# Developmental Disabilities Program > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2015-18070 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** July 27, 2015 - **Citation:** 80 FR 44796 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 1385, 1386, 1387, and 1388 RIN 0970-AB11 Developmental Disabilities Program AGENCY: Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living, HHS. ACTION: Final rule. SUMMARY: This rule implements the Developmental Disabilities Assistance and Bill of Rights Act of 2000. The previous regulations were completed in 1997 before the current law was passed. The rule will align the regulations and current statute and will provide guidance to AIDD grantees. DATES: These final regulations are effective August 26, 2015. FOR FURTHER INFORMATION CONTACT: Andrew Morris, Administration on Intellectual and Developmental Disabilities, telephone (202) 357-3424 (Voice). This is not a toll-free number. This document will be made available in alternative formats upon request. Written correspondence can be sent to Administration on Intellectual and Developmental Disabilities, U.S. Department of Health and Human Services, One Massachusetts Ave, Washington, DC 20201. SUPPLEMENTARY INFORMATION: I. Developmental Disabilities Assistance and Bill of Rights Act of 2000 In 1963, the President signed into law the Mental Retardation Facilities and Construction Act (Pub. L. 88-164). It gave the authority to plan activities and construct facilities to provide services to persons with “mental retardation”. 1 This legislation was significantly amended a number of times since 1963 and most recently by the Developmental Disabilities Assistance and Bill of Rights Act of 2000, Public Law 106-402 (the DD Act of 2000). 1 While developmental disability is the preferred contemporary language, mental retardation was the term used in 1963. Key changes in the DD Act of 2000 include: • The DD Act of 2000 requires State Councils on Developmental Disabilities (“Councils” or “SCDDs”) to set-aside 70 percent of the Federal funds for activities tied to Council goals (section 124(c)(5)(B)(i)). The previous amount was 65 percent. Also, the DD Act of 2000 increases the percentage from 50 percent to 60 percent of representation by individuals with developmental disabilities on Councils (section 125(b)(3)). • The DD Act of 2000 strengthens provisions regarding access to records of individuals with developmental disabilities that service providers hold, in order to investigate potential abuse and neglect. Also, the State must now provide information to a Protection and Advocacy (P&A) agency about the adequacy of health care and other services, supports, and assistance that individuals with developmental disabilities receive through home and community-based waivers. The DD Act of 2000 also defines the P&A governing board. The governing board is subject to section 144 of the Act. • Additionally, under the Act, the University Affiliated Programs are renamed University Centers for Excellence in Developmental Disabilities Education, Research, and Service (referred to as UCEDDs). Each UCEDD receives a core award. When appropriations are sufficient to provide at least $500,000, as adjusted for inflation, in funding to each existing UCEDD, AIDD, subject to availability of appropriations, awards grants for national training initiatives and is authorized to create additional UCEDDs or to make additional grants to existing UCEDDs. New UCEDDS created under this authority or additional grants to existing UCEDDs must be targeted to states or populations that are unserved or underserved (section 152(d)). • The DD Act of 2000 authorizes the Projects of National Significance (section 161) to carry out projects relating to the development of policies that reinforce and promote the self-determination, independence, productivity, and inclusion in community life of individuals with developmental disabilities. • Finally, the DD Act of 2000 also established two additional program authorities, Title II—Families of Children with Disabilities Support Act of 2000, and Title III—Program for Direct Support Workers Who Assist Individuals with Developmental Disabilities. Titles II and III of the DD Act of 2000 have not had funds appropriated by Congress and are not addressed in this rule. II. Grantees of the Administration on Intellectual and Developmental Disabilities (AIDD) Under the Act A. Federal Assistance to State Councils on Developmental Disabilities As stated in section 121 of the DD Act, formula grants are made to each State and other eligible jurisdictions to support a State Council on Developmental Disabilities (SCDD) to engage in advocacy, capacity building, and systemic change activities that assure that individuals with developmental disabilities and their families participate in service and program design, and have access to needed community services. These grants provide assistance that promotes self-determination, independence, productivity, and integration and inclusion in all facets of community living. Activities contribute to a coordinated, person and family-centered, person and family-directed, comprehensive system that includes needed community services, individualized supports, and other forms of assistance that promote self-determination for individuals with developmental disabilities and their families. It is noted that section 143 of the Act requires that a state have a functioning P&A system in order for the SCDD to receive funds. B. Protection and Advocacy for Individuals With Developmental Disabilities Formula grants are made to each State and other eligible jurisdictions to support a P&A system to protect and advocate for the rights of individuals with developmental disabilities. The system must have the authority to pursue legal, administrative, and other appropriate remedies or approaches to ensure the protection, advocacy and rights of individuals with developmental disabilities who are or who may be eligible for treatment, services, or habilitation, or who are being considered for a change in living arrangement. The system must provide information and referral for programs and services addressing the needs of individuals with developmental disabilities, and have the authority to investigate incidents of abuse and neglect of individuals with developmental disabilities if the incidents are reported to the system, or if there is probable cause to believe that the incidents occurred. C. Projects of National Significance Under subtitle E of title I of the Act, AIDD may award grants, contracts or cooperative agreements for Projects of National Significance (PNS) to create opportunities for individuals with developmental disabilities to directly and fully contribute to, and participate in, all facets of community life. Generally, projects are to support the development of national and state policies that reinforce and promote self- determination, independence, productivity, integration, and inclusion in all facets of community living. D. National Network of University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs) Grants are awarded to entities designated as University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs) in the States and other eligible jurisdictions to provide leadership; advise federal, state, and community policymakers; and promote self-determination, independence, productivity, and full integration of individuals with developmental disabilities. The UCEDDs are interdisciplinary education, research, and public service units of universities, or public or not-for-profit entities associated with the universities that engage in the core functions of interdisciplinary pre-service preparation and continuing education of students and fellows, provision of community services, conduct of research, and dissemination of information related to activities undertaken to address the purpose of title I of the Act. III. Discussion of Final Rule A Notice of Proposed Rule Making (NPRM) to address the requirements of the DD Act of 2000 was published on April 10, 2008 (73 FR 19708) and a subsequent document published on July 29, 2008 (73 FR 43904) reopened the comment period through September 29, 2008. This rule finalizes many of the policies that were included in the NPRM, as well as reorganizes some provisions based on court rulings and to provide clarity. The majority of comments received supported the focus on individuals with developmental disabilities living and participating in all aspects of community living. The following discusses issues raised in the NPRM: a. The NPRM substantially reorganized the regulatory text of 45 CFR chapter XIII, subchapter I, the Administration on Developmental Disabilities, Developmental Disabilities Program in full. To this end we have revised citations and made technical changes as necessary. The Administration on Developmental Disabilities became the Administration on Intellectual and Developmental Disabilities (AIDD) (as published in the Federal Register on April 18, 2012 (77 FR 23250). b. AIDD has made technical changes to make the rule consistent with the statute and related to the delegations of authorities published in the Federal Register on March 15, 2013 (78 FR 16511). These technical revisions further implement the Secretary's recent reorganization of the functions of the U.S. Department of Health and Human Services that created the Administration for Community Living (ACL). The new terminology “Secretary, or his or her designee,” is used to replace such terms as “Assistant Secretary” (referring to the Assistant Secretary of the Administration on Children and Families) and “Commissioner” (referring to the Administration on Disabilities Commissioner). c. The NPRM requested comment on “whether the current process involving class action lawsuits provides adequate protection for individuals with developmental disabilities,” and specifically, “on the procedures used to reach decisions on whether to pursue class action lawsuits and the method of informing/obtaining consent.” AIDD received many comments, both raising concerns about the use of class actions by P&As and expressing support for the outcomes P&As have accomplished via their legal advocacy generally, and the use of class action lawsuits specifically. Many commenters suggested that request for such comments deals with issues beyond the scope of AIDD's authority. AIDD considered the comments received and has chosen not to adopt new rules specifically governing the process for P&A's pursuing class action lawsuits. Some commenters recommended adding requirements for notification of ICF/IID 2 residents, families and legal guardians/representatives where applicable, as well as a specific “opt out” provision for this population. As explained above, we determined not to adopt new rules governing class action lawsuits. Class action lawsuits are governed by the Federal Rules of Civil Procedure, which already include notice provisions and we do not believe additional rules specific to P&A's pursuing class actions are required. The DD Act has as its mission protecting people with developmental disabilities from abuse and neglect, and class action lawsuits are an essential tool for such protection. Additional requirements creating procedural obstacles that do not exist for other civil rights enforcement actions may impede litigation that protects and enhances the rights of people with developmental disabilities. These suggested “opt out” and notice provisions singular to these types of cases may create additional hurdles and undermine the purposes of the DD Act, the Americans with Disabilities Act, and the Supreme Court decision in Olmstead . 2 In keeping with the rule from the Centers for Medicare and Medicaid Services, “Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction CMS-9070-F,” which took effect on July 12, 2012, this rule substitutes the term Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) for the former term Intermediate Care Facilities for Persons with Mental Retardation (ICF/MR). In addition, as many commenters noted, P&As utilize the tool of class actions lawsuits judiciously. For example see the 2003 report from GAO, “P&A Involvement in Deinstitutionalization Lawsuits on Behalf of Individuals with Development Disabilities,” available at http://www.gao.gov/new.items/d031044.pdf . The DD Act is clear in prioritizing full integration and inclusion of people with developmental disabilities, promoting self-determination, independence, productivity and integration and inclusion in all facets of community life. P&As have a central role in protecting the rights of individuals with developmental disabilities. Additional provisions beyond what is required in the Federal Rules of Civil Procedure could prevent P&As from fulfilling their mandate to enforce the rights of individuals with disabilities in the most effective manner. d. Many of the comments asked AIDD to define what a UCEDD is. The previous term “University Affiliated Program” was defined in previous regulations, but the new term “UCEDD” was not defined in the 2008 NPRM. We reviewed the comments and concurred that a clear definition for the UCEDD is necessary. To that end, part 1388 has been reorganized from what was in the NPRM, and language for Governance and Administration (which defines the structure of a UCEDD) has been restored from the previously published regulations to reflect the change from University Affiliated Programs to University Centers of Excellence in Developmental Disabilities. e. The NPRM invited comment on the question of activities to “advise,” “inform,” and/or “educate” federal, state, and local policymakers. The NPRM sought comment on the possible distinction between lobbying and the educational activities included in the statute. Sections 125(c)(5)(J), 143(a)(2)(L), and 153(a)(1), of the DD Act authorize the State Councils, P&As, and UCEDDS to engage in education, advising, and support of policymakers. Additionally, section 102(27)(E) defines the term “self-determination activities,” to envision self-advocacy, whereby individuals with developmental disabilities, themselves, educate policymakers and play a role in the development of public policies that affect them. Section 161(2)(D)(iii) also states that one of the purposes of the Projects of National Significance is to support the development of national and State policies that reinforce and promote such self-determination and inclusion through projects that provide education for policymakers. The majority of commenters stated support for educational activities while recognizing the restrictions with federal funds. AIDD issued guidance (ADD-01-1 dated September 20, 2001) on lobbying activities. AIDD grantees should continue to present information in a balanced and non-partisan manner that is consistent with the principles of the DD Act. Grantees may use non-federal funds for other policy related activities in accordance with relevant federal and state laws. We understand that grantees may have questions regarding the practice of advocacy. Many provisions of the DD Act specifically require grantees to engage in such activities as advocacy, capacity building, and/or systems change activities (sections 101(b)(1); 104(a)(3)(D)(ii)(I-III); 121(1); 124(c)(4); 124(c)(4)(L); 125(c)(2); 143(a)(2)(A)(i); 161(2)). AIDD may work with stakeholders to issue new or revised guidance on the subject to address these issues. Below is a section-by-section discussion of changes made between the NPRM and final rule: Part 1385—Requirements Applicable to the Developmental Disabilities Programs Section 1385.1 General Commenters suggested that the term “Protection and Advocacy of Individual Rights” (PAIR) be changed to “Protection and Advocacy for Individuals with Developmental Disabilities” (PADD) throughout the regulation. Though the term “Protection and Advocacy of Individual Rights” is used in the DD Act, the name is identical to a similar program administered by the Department of Education. For the sake of clarity, and as the term “Protection and Advocacy for Individuals with Developmental Disabilities” (PADD) is already regularly used to refer to the P&A program under the DD Act, we have substituted this terminology throughout the regulations. Section 1385.2 Purpose of the Regulation No changes were made from the NPRM. Section 1385.3 Definitions This section of the final rule updates definitions from the NPRM. The definitions in § 1385.3 are applicable to the rule in its entirety. Some definitions have been changed because the NPRM definitions went beyond the scope of the law. Accessibility The definition of accessibility has been changed to reflect the most current and up to date laws and regulations regarding section 504 of the Rehabilitation Act of 1973, and the Americans with Disabilities Act of 1990, and the Americans with Disabilities Act Amendments Act of 2008 (Pub. L. 110-325). AIDD This definition was added to reflect the change in organizational names from the Administration on Developmental Disabilities to the Administration on Intellectual and Developmental Disabilities in the process of the creation of the Administration for Community Living. Advocacy Activities AIDD received comments asking for the inclusion of systems change in the definition of “advocacy activities” and we concurred with comments. A minority of comments suggested removing “families” from the definition. AIDD disagreed with removing families from the definition as they play a key role in the lives of people with developmental disabilities and are specifically referenced throughout the statute, including in the purpose of the law. AIDD concurred with requests for a broader definition of advocacy activities, and expanded Advocacy Activities to include all aspects of community living. AIDD has revised the term “advocacy activities”. Assistive Technology Device AIDD received comments asking that the definition of “assistive technology device” be changed to the wording of the statute. AIDD concurred with the comments. Assistive Technology Service AIDD received comments asking that the definition of “assistive technology service” be changed to the wording of the statute. AIDD concurred with the comments. Capacity Building Activities AIDD received comments that the definition of “capacity building activities” did not include key processes and limited activities. Also, the NPRM changed the application of capacity building activities from the UCEDDs to all DD Act programs.. Based on comments received, the definition of capacity building activities has been clarified to include elements of community living, and made applicable to all the DD Act programs. Developmental Disability AIDD received multiple objections that the insertion of the term “determined on a case by case basis” regarding a developmental disability, with some commenting that it constituted an additional requirement not included in the statute.. AIDD concurred and removed it from the definition. The definition as passed in the 2000 reauthorization did not include such language requiring that each person with a developmental disability be determined on a case by case basis. Multiple commenters opined that that phrase excessively puts a medical diagnosis on developmental disabilities. Inclusion We received comments asking that the definition of “inclusion” be changed to the wording of the statute. We concurred with the comments. State We made a technical revision that was an error in the NPRM for the definition of “State”. For the purposes of the UCEDD grants, American Samoa and the Commonwealth of the Northern Mariana Islands are not considered States. See section 155 of the DD Act, 42 U.S.C. 15065. Supported Employment Services We received comments asking that the definition for “supported employment services” be changed to the wording of the statute. We concurred with the comments. Section 1385.4 Rights of Individuals With Developmental Disabilities No changes were made from the NPRM. Section 1385.5 Program Accountability and Indicators of Progress This section of the NPRM is not being developed into a final rule. We generally received unfavorable comments from stakeholders that the requirements would place an administrative and cost burden on grantees. We concurred, as AIDD does not want to place undue hardships on grantees. We have concluded that additional guidance is unnecessary at this time. Since the law was passed AIDD has issued OMB approved reporting requirements that are consistent with the Act. See OMB approved reporting in the Impact Statement of the Preamble. Section 1385.6 Employment of Individuals With Disabilities There were no changes made to this section in the final rule from the NPRM. Section 1385.7 Reports of the Secretary There were no changes made to this section in the final rule from the NPRM. Section 1385.8 Formula for Determining Allotment To reflect the accuracy of the allotment process as defined in the statute, the final rule has been amended to replicate sections 122 and 142 of the Act. Section 1385.9 Grants Administration There were no changes made to this section in the final rule from the NPRM. Part 1386—Formula Grant Programs Subpart A—Basic Requirements Section 1386.1 General The final rule makes technical changes to § 1386.1 to update the terminology. Section 1386.2 Obligation of Funds Similarly, the final rule revises § 1386.2 to update terminology. Subpart B—Protection and Advocacy for Individuals with Developmental Disabilities (PADD). We have revised the title of subpart B to read: Subpart B—Protection and Advocacy for Individuals with Developmental Disabilities (PADD). Section 1386.19 Definitions A number of comments were received on the definitions proposed in the NPRM with respect to subparts B, § 1386.19, requesting that modifications be made to the below definitions of “Abuse,” “Complaint,” “Legal Guardian, Conservator and Legal Representative,” “Neglect,” “Probable Cause,” and “Service Provider.” Abuse AIDD received numerous comments on the definition of “abuse.” Commenters recommended including the language “willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish” in the definition. The DD Act authorizes P&As to investigate incidents of abuse and neglect, as in section 143(a)(2)(B), to protect individuals with developmental disabilities, regardless of the intent of the alleged abuser. Determining “willful infliction” may also require further information to establish such intent, which would, in turn, complicate and even potentially eliminate, a P&A's ability to conduct an appropriate investigation. After careful consideration, AIDD did not include this recommended change in the final rule. Some commenters suggested removing the phrase “repeated and/or egregious,” from the definition of abuse. AIDD removed “repeated and egregious,” as suggested. This change is consistent with the language of the DD Act, which states that one of its purposes is to provide individuals with developmental disabilities the opportunity and support “to live free of abuse, neglect, financial and sexual exploitation, and violations of their legal and human rights” (section 101(a)(16)(F) of the DD Act, 42 U.S.C. 15001(a)(16)(F)). Even a single instance of the aforementioned treatment is should be sufficient to constitute the type of circumstance that would give a P&A authority to initiate an investigation. Commenters also recommended substituting “legal” for “statutory and constitutional” in the definition. AIDD made the recommended change, as P&A authority must include the ability to investigate violations of regulations and judicial precedent; P&A investigatory authority is not limited only to violations of statutory or constitutional law. Finally, some commenters suggested deleting the phrase “which may prevent the individual from providing for his or her basic needs such as food and shelter” from the definition with respect to financial exploitation. Financial exploitation is a type of abuse which falls within the investigatory authority of P&As, and individuals with developmental disabilities can be subject to this type of abuse even when the individual is able to take care of basic food and shelter needs. AIDD adopted the recommendation and removed the phrase “which may prevent the individual from providing for his or her basic needs such as food and shelter” from the final rule. Complaint Commenters suggested that “complaint” be defined to include “from any source relating to alleged abuse or neglect,” rather than “from any source relating to status or treatment,” as “status” and “treatment” are not defined in the proposed regulations. The language “from any source alleging abuse or neglect,” was adopted into the final rule as it is consistent with the prior DD Act regulations, as well as with the Protection and Advocacy for Individuals with Mental Illness (PAIMI regulations, 42 CFR 51.2). Another commenter recommended that the definition include a clarification that an individual's residential placement does not, alone, constitute a complaint issue. Related, other commenters expressed concern that residential status in the context of the definition would lead to potentially inappropriate investigations by the P&As, and recommended that the definition include specific language stating that an individual's residential placement, if not related to quality issues, does not constitute a complaint issue. AIDD has considered these suggestions and did not adopt the suggested change. Residential status may be a part of the determination of whether an investigation should be initiated by a P&A under the DD Act. The DD Act includes the authority to protect and advocate for the rights of individuals “who . . . are being considered for a change in living arrangements” in section 143(a)(2)(A)(i), and P&As must apply these principles in accordance with the intent of the law. An example of such principles can be found in section 109(a)(2), “treatment, services, and habitation for an individual with developmental disabilities should be designed to maximize the potential of the individual and should be provided in the setting that is least restrictive of the individual's personal liberty.” Commenters also suggested the term “alleging” be added to modify “abuse or neglect.” AIDD adopted this change, as the P&A may not yet have determined whether abuse or neglect has actually occurred at the complaint stage. AIDD also included “electronic communications,” and other media to provide an additional, relevant and technologically up-to-date example of a type of communication that a P&A may receive that may fall under this definition. Legal Guardian, Conservator and Legal Representative Based on comments received, AIDD has modified the definition of “legal guardian, conservator and legal representative,” to include “a parent of a minor, unless the State has appointed another legal guardian under applicable State law,” to be consistent with the findings of the district court in State of Connecticut Office of Protection and Advocacy for Persons with Disabilities v. Hartford Bd. of Ed, 464 F.3d 229 (2d Cir. 2006) (holding that P&A has access to names and contact information for parents and/or guardians of certain students). Commenters also recommended adding “executors and administrators of estates,” to the list of excluded categories, a change AIDD instituted for the sake of clarity. Finally, commenters recommended substituting “services, supports and other assistance” for “treatment and habilitation services,” and AIDD made that change, to be consistent with the principles of the DD Act and to explicitly express that the DD Act covers a broad range of services. Neglect Some commenters recommended the addition of “failure to take appropriate steps to prevent harassment or assault by a peer or self-abuse” to the term “neglect.” P&As need the authority to investigate acts or omissions leading to this type of situation, which can put the health, safety and life of an individual with a developmental disability at risk. AIDD accepted the proposed change. Another commenter recommended alternative modifications, including concerns similar to the issue raised regarding the definition of abuse, suggesting that “repeated” be part of the definition. The DD Act seeks to ensure that people with developmental disabilities “live free of . . . neglect” in section 101(a)(16)(F). AIDD did not accept the proposed change, as the DD Act does not require “repeated” incidents to qualify under this definition. One commenter objected to the continued inclusion of the existence of a discharge plan in the definition of “neglect.” AIDD considered this comment, and rejected it. Since at least 1996, the regulations have contained language about failing to establish or carry out a discharge plan. Probable Cause Commenters suggested adding language to the body of the rule to the effect that the definition is not intended to affect the authority of the courts to review the determinations of P&As as to whether probable cause exists. However, we did not accept this change, as AIDD does not have authority over court jurisdiction. Commenters also suggested removing the phrase “depending on the context,” as ambiguous and unnecessary. AIDD agreed and removed the phrase accordingly. Some commenters suggested that the definition in the NPRM failed to provide constitutionally mandated due process and was unclear. The NPRM stated that “the P&A system is the final arbiter of probable cause between itself and the organization or individuals from whom it is seeking records.” We agreed that the language is unnecessary and deleted it. Where a P&A determines it has reasonable belief that an individual with developmental disabilities has been, or may be, subject to abuse or neglect, it has a legally enforceable right to access the records or individuals sought, in compliance with relevant statutes and regulatory provisions. A commenter suggested creating an alternative process to address circumstances when a service provider wants to withhold access and challenges the standard. AIDD believes that would be excessively burdensome and did not incorporate the suggestion. Where there is controversy between the P&A and service provider, the P&A makes the relevant determination, in the interest of providing strong protection of and advocacy for people with developmental disabilities in keeping with the purpose of the DD Act. In situations regarding abuse and neglect, the court remains the “final arbiter” with respect to determining whether an adequate basis for probable cause exists. Service Provider The NPRM proposed a new definition of “Service Provider,” but has chosen not to finalize it. This is due to the rapidly changing nature of who provides services, and the tremendous variation in the delivery of supports in a broad range of settings. To define an exemplary list of “service providers” in a regulation would not allow for the broad range of entities currently providing services to be inclusively represented. The DD Act is clear that P&As have access to people with developmental disabilities, “in a location in which services, supports, and other assistance are provided . . .” (section 143(a)(2)(H)). However the law is not explicit about who might be providing such services, intentionally leaving this flexibility to evolve with systems. Twenty years ago it was common for an individual to live in a large congregate setting. Now an individual is more likely to be living in a small group home, in an adult supported living (foster) home, with his or her own family or family member, or independently in his or her own home. AIDD received comments asking for possible types of service providers to be listed, but determined that publishing a specific list might create a perception that any list is exhaustive or potentially over-inclusive. Service Recipient Commenters recommended replacing the term “service recipient” with “individual with developmental disabilities,” where appropriate, throughout the regulations. The term “service recipient” was not defined in the proposed regulation, and it also represents passive language not in alignment with the DD Act. To reflect the fact that service recipient is not a defined term, the final rule alters terminology was altered in §§ 1386.26, 1386.27, and 1386.28 and in relevant subject headings to refer to “individuals with developmental disabilities”. This change is not intended to affect the scope of the P&A's legal authority as outlined in the regulations. Section 1386.20 Agency Designated as the State Protection and Advocacy System Similar to the proposed rule, the final rule revises the heading of § 1386.20 to Agency Designated as the State Protection and Advocacy System from Designated State Protection and Advocacy Agency. Commenters recommended that the redesignation process described in paragraph (d) include an opportunity for an oral administrative hearing before an independent authority. AIDD considered this comment, but declines to make that addition to the regulations as the requested change would necessitate an undue administrative burden on the agency. AIDD made technical changes in § 1386.20(d)(2)(vi) and (d)(3) requiring accessible formats and access for individuals with limited English proficiency. AIDD removed examples of outdated technology in § 1386.20(d)(3). Section 1386.21 Requirements and Authority of the State Protection and Advocacy System AIDD revised the title to include a reference to “State” in relation to the Protection and Advocacy System and updated terminology and statutory cites. Commenters expressed support for § 1386.21(c) as written in the NPRM, which revised the regulation to include additional language regarding prohibited State actions which would diminish or interfere with the exercise of the required authority of the P&As. No changes were made to the language in this section of the final rule. In paragraph (g), we are adding a statement indicating governing boards are also required to have a majority of individuals with disabilities or their family members. This brings the rule in alignment with the statute. Regarding § 1386.21(j), commenters recommended the inclusion of a new subsection to allow the P&As to enter into contracts for part of their programs. AIDD agreed that this option would allow greater flexibility for monitoring in remote areas, and for entering into special initiatives. P&As have explicit oversight responsibilities to ensure the contractor organizations meets all of the standards and requirements applicable to the P&As. The language in § 1386.21(j) reflects the field's evolving understanding of legal standing in the P&A context. Section 1386.22 Periodic Reports: State Protection and Advocacy System The P&A system shall continue to comply with the reporting requirements of the law and applicable regulations, in accordance with OMB approved reports. Section 1386.23 Non-allowable costs for the State Protection and Advocacy System No changes were made in this section. Section 1386.24 Allowable litigation costs for the State Protection and Advocacy System No substantive changes from the NPRM were made in this section. Subpart C—Access to Records, Service Providers and Individuals With Developmental Disabilities As noted above, the terminology in the title of subpart C of part 1386—Formula Grant Programs was changed from “Service Recipients” to “Individuals with Developmental Disabilities,” to be consistent with changes made in response to comments received, emphasizing clearer and more active language. General Context—Subpart C As explained in the NPRM, this rule addresses key provisions in Subtitle C of the Act (42 U.S.C. 15043)(a)(1); (2)(A), (H), (I), (J); and (c)) on Protection and Advocacy for Individuals with Developmental Disabilities. These provisions of the DD Act pertain to P&A access to service providers, access to individuals with developmental disabilities, and access to records. The rule also offers some examples of records to which a P&A shall have access. Given the obligation of P&As to conduct investigations of incidences of abuse and neglect, as well as the statutory authority under section 143(a)(2)(I) to, in certain circumstances, contact an individual's guardian, conservator or legal representative, AIDD has taken the position that a P&A shall have prompt access to contact information of such individuals. AIDD's determination also is supported by law by the Second Circuit Court decision in the case, State of Conn. Office of Protection and Advocacy for Persons with Disabilities v. Hartford Board of Education, 464 F.3d 229 (2nd Cir. 2006) (holding that the P&A had the right to access a learning academy to investigate complaints of abuse and neglect at the school and to obtain the directory of students with contact information for parents and guardians). AIDD notes the importance of accessing records of individuals with developmental disabilities in order for the P&A system to investigate suspected cases of abuse and neglect. As discussed in the NPRM, many of the changes in this subpart reflect the access authority language contained in sections 143(a)(2)(I) and (J) of the Act (42 U.S.C. 15043(a)(2)(I) and (J)). Where we exercise discretion, we do so in the belief that the proposed provisions are necessary to meet Congress' underlying intent to ensure necessary access to records to promote the P&A's authority to investigate abuse and neglect and to ensure the protection of rights. This broad interpretation of available records and reports also is consistent with the requirements of the PAIMI regulations (42 CFR 51.41). Ensuring that interpretations of statutory authority are included in regulation also allows P&As to minimize the amount of resources spent on determining the standards for access, in service of protecting and advocating for the legal and human rights of individuals with developmental disabilities. The DD Act and this rule are very specific in terms of when consent for records is required. In situations in which an individual's health and safety are in immediate jeopardy or a death has occurred, no consent is required and access to records must be provided no later than within 24 hours (42 U.S.C. 15043(a)(2)(J)(ii)). AIDD recognizes that P&As are charged with engaging in a range of activities that necessitate access to people with developmental disabilities. Examples of such activities include but are not limited to protecting the legal and human rights of individuals with developmental disabilities, monitoring for incidents of abuse or neglect, and monitoring health and safety. The DD Act requires that a P&A have access at reasonable times to any individual with a developmental disability in a location in which services, supports, and other assistance are provided to such an individual, in order to carry out the purpose of Subtitle C (42 U.S.C. 15043)(a)(2)(H)). It is important to note that neither the DD Act, nor this rule, makes a distinction on the basis of age with regard to access of an individual with a developmental disability by the P&A. Specific Changes/Additions to Subpart C Section 1386.25 Access to Records Regarding § 1386.25(a)(1), commenters recommended replacing the term “client” with “individual with a developmental disability.” AIDD considered that comment and rejected it. The term “client” connotes a specific relationship, which implies certain duties between the client and the P&A system. Though P&A access authority is not limited to clients, the term “client,” is not interchangeable with “individual with a developmental disability.” The term client is also used in the Act in section 143(a)(2)(I)(i). Regarding § 1386.25(a)(2)(iii), commenters recommended removing “about his or her status or treatment,” as the term “complaint” is adequately defined in § 1386.19. For clarity, the phrase has been removed. Commenters also recommended removal of “by any other individual or has subjected him or herself to self-abuse,” to modify “neglect.” This language was removed, as it is now included in the definition of neglect in § 1386.19. In § 1386.25(a)(3), AIDD removed “by any other individual or has subjected him or herself to self-abuse,” as this language has been added to the definition of neglect in § 1386.19. Regarding § 1386.25(a)(3)(i), we added a requirement for disclosure of the name and address of a representative be given to the P&A promptly. In response to comments and to improve clarity, AIDD has added “telephone number(s)” of the legal guardian, conservator, or other legal representative, to be consistent with proposed § 1386.26, and “within the timelines set forth in § 1386.25(c),” to be consistent with the express time periods established in that section. Regarding § 1386.25(a)(3)(iii), commenters suggested replacing “act” with “provide consent” and AIDD made this change to clarify the intent of the provision, in accordance with judicial interpretation and the intent of the law. AIDD finds the DD Act encourages the broad applicability of access authority to records when there is a complaint or probable cause of abuse and neglect. For example, a P&A may need to access records in a situation where the guardian is allegedly abusing or neglecting his/her ward. A majority of courts have recognized that P&As should be permitted to access records in these situations when a guardian has refused to consent to their release. 3 AIDD had included this change in language to reflect an interpretation weighted toward the protection of individuals with developmental disabilities. 3 See, e.g., Pennsylvania Protection & Advocacy, Inc. v. Royer-Greaves Sch. for the Blind, 1999 WL 179797, *8 (E.D. Pa., March 25, 1999)(permitting P&A to access records even when guardian expressly refused to consent to release of records); Disability Law Center v. Reil, 130 F. Supp. 2d 294 (D. Ma. 2001)(court ordered service provider to release records notwithstanding the guardian`s good faith refusal to do so). But see, Disability Law Center v. Millcreek Health Center, 339 F.Supp.2d 1280 (D. Utah 2004), vacated, 428 F.3d 992 (10th Cir. 2005) (court denied P&A`s access to records because an actively involved guardian refused to give consent). For the final rule, AIDD also added § 1386.25(a)(4) and (5) to include language from commenters, regarding P&A access authority to records without consent in cases where an individual with developmental disabilities has died, or if the P&A has probable cause to believe that the health or safety of an individual with developmental disabilities is in serious and immediate jeopardy, consistent with the DD Act, 42 U.S.C. 15043(a)(2)(J)(ii)(I) and (II). Regarding § 1386.25(b)(1), commenters suggested adding language to include records that were not prepared by the service provider, but received by the service provider from other service providers. AIDD amended the section accordingly, per the authority of the DD Act, that a P&A be able to access “all records” of an individual with a developmental disability, 42 U.S.C. 15043(a)(2)(I), to the extent allowed by law. Such records may include information that is relevant to the P&A's work, and shall be accessible to P&A's. A commenter recommended deleting § 1386.25(b)(1), describing this section as providing “inappropriate access to records” because it would give P&As too broad of access to records and be duplicative of existing requirements for providers with oversight by the Centers for Medicare and Medicaid Services. Congress intended to ensure access to records consistent with the P&A's authority to investigate abuse or neglect and ensure the protection of rights. AIDD did not accept the suggested change. Regarding § 1386.25(b)(2), commenters suggested removing: “The reports subject to this requirement include, but are not limited to, those prepared or maintained by agencies with responsibility for overseeing human services systems.” AIDD eliminated the sentence, as “human services system” is undefined, potentially unclear, and this phrase may serve to unduly limit the types of reports P&As can receive. Commenters also recommended numerous additions to this section regarding the organizations whose reports are subject to this requirement. AIDD included various additional examples that may be helpful for clarifying the types of facilities and organizations providing services, supports and other assistance to individuals with developmental disabilities from which P&As have access to records. These additions are clarifying examples and are not intended to limit the types of organizations whose reports are subject to this requirement. With respect to the reports subject to this requirement, commenters recommended adding “or by medical care evaluation or peer review committees, regardless of whether they are protected by federal or state law” to § 1386.25(b)(2). AIDD has adopted the recommended change because this addition facilitates the P&As fulfilling their responsibilities under the DD Act, maximizes the most efficient use of resources, and is consistent with court decisions allowing P&As access to all records of an individual. 4 Peer review records shall be handled in accordance with the confidentiality requirements as described in § 1386.28 of this rule. 4 See, e.g. Pennsylvania Protection and Advocacy, Inc. v. Houstoun, 228 F.3d 423, 428 (3rd Cir. 2000); Center for Legal Advocacy v. Hammons, 323 F.3d 1262, 1270 (10th Cir. 2003); Protection & Advocacy for Persons with Disabilities v. Mental Health & Addiction Services, 448 F.3d 119 (2d Cir. 2006); Missouri Prot. & Advocacy Servs. v. Missouri Dep't of Mental Health, 447 F.3d 1021, 1023-1024 (8th Cir. 2006); Protection & Advocacy for Persons with Disabilities, Conn. v. Mental Health & Addiction Servs., 448 F.3d 119, 128 (2d Cir. 2006); Indiana Prot. & Advocacy Servs. v. Indiana Family & Social Servs. Admin., 603 F.3d 365, 382-383 (7th Cir. 2010) (en banc), petition for cert. pending, No. 10-131(filed July 21, 2010); Disability Law Center of Alaska v. North Star Behavioral Health, 3:07-cv-00062 JWS, 2008 WL 853639 (D. Alaska, March 27, 2008). Regarding § 1386.25(b)(4), commenters recommended adding “information in professional, performance building, or other safety standards, demographic and statistical information relating to a service provider.” AIDD restored the language that the NPRM deleted, as found in § 1386.22(c)(2) of the 1997 regulations. This is consistent with the DD Act provision, 42 U.S.C. 15043(a)(2)(I), that a P&A be able to access “all records” of an individual with a developmental disability, 42 U.S.C 15043(a)(2)(J), and we have substituted “service provider” for “facility,” as discussed previously. Commenters suggested reformulation of the NPRM § 1386.25(c) regarding time periods. AIDD added additional § 1386.25(a)(4) and (5), regarding access to records without consent when a P&A determines there is probable cause to believe the health and safety of an individual is in serious or immediate jeopardy, and in the case of death of an individual with a developmental disability. With the additions of § 1386.25(a)(4) and (5), AIDD has removed the NPRM language defining access to records in the case of death. AIDD has retained § 1386.25(c)(1) from the NPRM, to address circumstances where access to records must be provided within 24 hours of receipt of a written request from P&As. AIDD has also retained § 1386.25(c)(2), specifying access within three business days from receipt of written request in all other cases. AIDD considered recommended revisions, and determined that the current formulation best captures the specifics of section 143(a)(2)(J)(i) and (ii) of the DD Act. Section 1386.25(d) addresses the remaining provisions regarding sharing and copying of records, consistent with the corresponding PAIMI regulation, (42 CFR 51.41) which states that the P&A system may not be charged for copies more than is “reasonable” according to prevailing local rates, certainly not a rate higher than that charged by any other service provider, and that nothing shall prevent a system from negotiating a lower fee or no fee. Regarding § 1386.25(d), commenters recommended adding a specific monetary cap to the amount charged by a service provider or its agents to copy records for the P&A system. AIDD added a provision linking the amount charged in these circumstances to the amount customarily charged other non-profit or State government agencies for reproducing documents, to avoid prohibitive charges as a barrier to accessing appropriate records. AIDD recognizes that many records are now being transitioned and maintained electronically. To that end, when records are kept or maintained electronically they shall be provided electronically to the P&A. Regarding § 1386.25(e), commenters recommended adding a provision making explicit that the Health Insurance Portability and Accountability Act (HIPAA) permits the disclosure of protected health information (PHI) without the authorization of the individual to a P&A system to the extent that such disclosure is required by law and the disclosure complies with the requirements of that law. This provision accords with the HIPAA Privacy Rule, 5 and AIDD has included it in this rule. Readers may refer to sections 143(a)(2), (A)(i), (B), (I) and (J) of the DD Act for provisions governing disclosure required by law. We consider a disclosure to be required by law under the DD Act where the access is required under 45 CFR 1386.25 and the disclosure is in accordance with such regulation. 5 See Dep't of Health and Human Services, Health Information Privacy, Frequently Asked Questions, at http://www.hhs.gov/ocr/privacy/hipaa/faq/disclosures_required_by_law/909.html (last visited March 1, 2012) (“May a covered entity disclose protected health information to a Protection and Advocacy system where the disclosure is required by law? Answer: Yes.”). Regarding § 1386.25(f), commenters recommended the addition of a provision specifying the authority of P&As to access records of schools, educational agencies, etc. An amicus brief submitted by the Department of Justice (DOJ), on behalf of the Department of Education and the Department of Health and Human Services, took the position that a school must provide a P&A with the name and contact information for the parent or guardian of a student for whom the P&A has the requisite degree of probable cause to obtain records under the DD Act ( State of Connecticut Office of Protection and Advocacy for Persons with Disabilities v. Hartford Bd. of Ed, 464 F.3d 229 (2nd Cir. 2006) ). DOJ also asserted that a P&A may interview a minor student suspected of being subject to abuse or neglect without prior consent from a parent or guardian. In addition, “[i]f the P&A has probable cause `to believe that the health and safety of the individual is in serious and immediate jeopardy,' it shall have access to records immediately without notice to or consent from a parent or guardian.” The Second Circuit adopted DOJ's position on both of these issues. DOJ also asserted the government's position that the Court should “construe the DD Act [and PAIMI Act] as an override of the Family Educational Rights and Privacy Act (FERPA) non-disclosure requirements, in the narrow context where those statutes require that a P&A have authority to obtain student records held by an institution servicing disabled and/or mentally ill students.” However, after the government submitted its brief, Appellants abandoned their FERPA arguments. Consequently, the Court did not issue an opinion with respect to the interplay of FERPA and the PAIMI and DD Acts. Additionally, in 2009 the Ninth Circuit Court ruled in Disability Law Center of Alaska, Inc. v. Anchorage School District that P&As have an override of FERPA to have access to contact information for parents, guardians, or representatives of student. 581 F. 3d 936 (9th Cir. 2009). It remains AIDD's position that the role of P&As as established in the DD Act provides for an override of FERPA to permit a P&A to access names and contact information for the parents or guardians of students with developmental disabilities, where the P&A's determination of probable cause satisfies the substantive standards for record access. Section 1386.26 Denial or Delay of Access to Records P&As must be able to obtain the identities of individuals with developmental disabilities from service providers (who have control of this information). In emergency situations or in the case of the death of an individual with developmental disabilities receiving services, section 143(a)(2)(J)(ii) of the DD Act requires that P&As have access to records of individuals with developmental disabilities receiving services within 24 hours after written request is made and without consent. AIDD believes that establishing a deadline for providing the written justification denying access is necessary in recognition of the consequences of not accessing relevant information quickly. This is particularly necessary when there are allegations of abuse or neglect, probable cause to believe that the health or safety of the individual is in serious and immediate jeopardy, or in the case of a death. Some commenters expressed the need for a specific penalty in cases of denial or delay if a service provider fails to provide a written statement giving reason for denial of access to records. AIDD considered the comment, but is not attempting to impose penalties via these regulations, as AIDD does not have the authority to do so. Commenters also recommended the inclusion of [individuals with] “intellectual disabilities.” That term is not included in the DD Act nor defined with respect to the scope of individuals included in that category for the purposes of these regulations; we have not included it in this section. AIDD modified the section to clarify that § 1386.26 is applicable specifically to access to records, to effectuate the purposes of Sec. 143(a)(2)(J)(ii) of the DD Act and to address comments submitted regarding possible confusion of timing implications of these denial or delay of access provisions, and the provisions for access in § 1386.27. Section 1386.27 Access to Service Providers and Individuals With Developmental Disabilities AIDD again notes the change from the term “service recipients” to “individuals with developmental disabilities” in the heading and throughout the section, with the same justification as in § 1386.22. Under this section, the term “service provider” is substituted throughout for the term “facility.” The term “programs” is undefined in the regulations, and the final language more precisely expresses the parties and items with respect to whom the P&As seek access, with more active language than “recipients.” Section 143(a)(2)(H) of the DD Act (42 U.S.C. 15043) requires that P&As “have access at reasonable times to any individual with a developmental disability in a location in which services, supports, and other assistance are provided to an individual.” P&A systems must not be required to provide advance notice to a service provider when investigating an allegation of abuse or neglect, when they have probable cause to believe that the health or safety of the individual is in serious and immediate jeopardy, or in the case of a death. To serve the monitoring function described in section 143(a)(2)(I) of the Act, P&As must also have the ability to make unannounced visits to check for compliance regarding the health and safety of individuals with developmental disabilities. Immediate access may also be necessary, for example, to prevent interested parties from concealing situations involving abuse or neglect or taking actions that may compromise evidence related to such incidents (such as intimidating staff or individuals with developmental disabilities who are receiving services). Thus, AIDD added the following provision, in keeping with the recommendation from commenters: “Service providers shall provide such access without advance notice from the P&A.” Some commenters recommended creating separate sections for access to “locations” and access to “individuals with developmental disabilities and other individuals.” To minimize confusion, AIDD maintained the original structure from the proposed regulations, with modifications and reordering where needed for clarity. Regarding § 1386.27(c) in the NPRM, commenters suggested adding the following language to the section on consent to attend treatment planning meetings, “except that no consent is required if (1) the individual, due to his or her mental or physical condition, is unable to authorize the system to have access to a treatment planning meeting, and (2) the individual does not have a legal guardian, conservator or other legal representative, or the individual's guardian is the State (or one of its political subdivisions).” The proposed language addresses potential conflicts of interest regarding consent to P&A access to attend a treatment planning meeting. AIDD adopted this change and included parallel language to the similar provisions regarding state guardians in records access provisions § 1386.25(a)(2)(i). AIDD received a comment asking that a physician note be required if the service provider denies the P&A access to an individual. We concurred with the comment and added language setting forth the specific process to be followed in situations where access is denied based on the justification that it would interfere with an individual's treatment, this was done to minimize confusion and to underscore section 143(a)(2)(H) of the Act. Section 143(a)(2)(H) gives P&As access at reasonable times to any individual with a developmental disability in a location in which services, supports and other assistances are provided in order to carry out the purposes of P&As under the DD Act. AIDD included these changes to clarify that access be permitted to treatment planning meetings (with the consent of the individual or his or her guardian), as such access is needed to assure that service providers are protecting the health and safety of individuals with developmental disabilities receiving services. AIDD also explained in the proposed rule that the regulations are supported by the legislative history of the PAIMI Act, which provides that P&As must be afforded “access to meetings within the facility regarding investigations of abuse and neglect and to discharge planning sessions.” S. Rep. 454, 100th Cong., 2d Sess. (1988). To assure consistency with the PAIMI program, P&As are authorized to attend treatment team meetings, which serve some of the same purposes as discharge planning sessions. The DD Act supports broad access to individuals to monitor conditions relating to safety and health. With respect to § 1386.27(c)(3) in the NPRM, commenters suggested a number of modifications. In response to such comments, AIDD has specified that access is “including but not limited to” inspecting, viewing, and photographing all areas of a service provider's premises. We have also added the phrase “or under the service provider's supervision or control,” to more clearly specify the areas covered under this section. Commenters suggested including “video recording” to the list of access activities: inspecting, viewing, and photographing. AIDD adopted this change as a helpful clarification. AIDD also included the following carve out, to safeguard the privacy and preferences of individuals with developmental disabilities, in keeping with the values of choice and self-determination in the DD Act: “but shall not include photographing or video recording individuals with developmental disabilities unless they consent or state laws allow such activities.” Commenters suggested replacing the NPRM language, “at reasonable times” in the introductory portion of § 1386.27(c) with “at all times.” AIDD did not make the change, as the DD Act provision regarding access to an individual with a developmental disability states a P&A shall have access at “reasonable times” 42 U.S.C. 15043(a)(2)(H). With respect to § 1386.27(d) in the NPRM, commenters recommended adding provisions on the specifics of the ability of P&As to access individuals with developmental disabilities. AIDD added language with specifics on the P&A's access authority for these individuals. This includes protection of P&As against compulsion to disclose the identity of such individuals to the service provider, except as required by law. The P&As were established under the DD Act to protect and advocate for the legal and human rights of people with developmental disabilities. That purpose would be defeated if individuals with developmental disabilities or their guardians, conservators, or other legal representatives become subject to retribution for reaching out to a P&A seeking information about a P&A and their services, or to report a suspected incident of abuse or neglect. A few commenters recommended that § 1386.27 should clarify that P&A access to service providers and “recipients” must be based on substantial allegations of wrongdoing and should only involve individuals with developmental disabilities that are the subject of wrongdoing. AIDD carefully considered these comments and determined that the DD Act expresses a broader intent, that includes, e.g., the authority to “have access . . . to any individual with a developmental disability in a location in which services, supports, and other assistance are provided to such an individual,” section 143(a)(2)(H). This includes a P&A role of monitoring, as well as, “providing information . . . and referral,” as stated in section 143(a)(2)(A)(ii) which allows for access in circumstances beyond where there is a pre-existing substantial allegation of wrongdoing. Commenters suggested adding a section on access to Individuals with Developmental Disabilities and Locations for the purpose of providing information, training, and referral for programs. The recommended language includes the following: “P&As shall have access to individuals with disabilities and the locations in which they are receiving services, supports and other assistance for the purpose of providing information, training, and referral for programs addressing the needs of individuals with developmental disabilities, and information and training about individual rights, and the protection and advocacy services available from the P&A system, including the name, address, and telephone number of the P&A system. Service providers shall post, in an area which is used by individuals with developmental disabilities, a poster which states the protection and advocacy services available from the P&A system, including the name, address, and telephone number of the P&A system.” AIDD agrees that for P&As to accomplish the goal of protecting the legal and human rights of individuals with developmental disabilities, the people who need these services should be aware that such services are available, as well as how to access this resource. AIDD has included a clarification that P&As may have access for purposes of providing such information at § 1327(c)(2)(i). Finally, § 1386.27 has been reorganized and renumbered to clarify the access requirements and authorities when P&As investigate incidents of abuse and neglect of individuals with developmental disabilities, as well as in implementing their additional responsibilities under the DD Act. This addresses conflicting comments suggesting that the access authority as identified in this section is both overbroad and too limited. AIDD carefully considered the input, and revised the section to reflect the agency's understanding of P&A access authority to protect the legal and human rights of individuals with developmental disabilities under the DD Act. Section 1386.28 Confidentiality of Protection and Advocacy System Records Similar to the approach used in the PAIMI regulation at 42 CFR 51.45, AIDD, in the NPRM, incorporated a new section at § 1386.28, Confidentiality of Protection and Advocacy Systems Records. This section will replace the current AIDD regulation in 45 CFR 1386.22(e), Access to Records, Facilities and Individuals that deals with P&A access authority. Some commenters recommended an essential rewriting of § 1386.28, stating that some provisions of these regulations could be interpreted to “thwart the fundamental P&A mandate of protecting individuals with [developmental] disabilities from abuse or neglect while maintaining appropriate confidentiality.” However, the commenters were not specific with problems that an essential rewrite would resolve. AIDD did not accept wholesale language commenters proposed; however AIDD did make the following changes below. Commenters recommended new language with respect to confidentiality provisions. AIDD included the following § 1386.28(a), as it explicitly articulates existing applicable duties: “A P&A shall, at minimum, comply with the confidentiality provisions of all applicable Federal and State laws.” Commenters also requested additions clarifying circumstances where information can be disclosed, citing shortcomings in the NPRM, but without offering specific examples of the problems raised by the proposed language. AIDD has maintained the language from the NPRM (renumbered where necessary), for the sake of consistency with the PAIMI confidentiality provisions, at 42 CFR 51.45, to ensure strong confidentiality protections and certainty of integrity are maintained. In addition, one commenter suggested that the regulations must make clear that the DD Act funding shall not be used to advocate against and in any way undermine, downsize or close a Medicaid certified and licensed facility [ICF/IDD]. The purpose of the Act clearly articulated, in 42 U.S.C. 15001(b), “to assure that individuals with developmental disabilities and their families participate in the design of and have access to needed community services, individualized supports, and other forms of assistance that promote self-determination, independence, productivity, and integration and inclusion in all facets of community life, through culturally competent programs authorized under this title . . .” applies broadly. The law makes no provision to carve out a category of care facilities to which the provisions of the Act do not apply, and AIDD does not do so here. A commenter also stated that “the regulations must clearly state that a P&A is not permitted to access private homes, unless accompanied by the existing state authorities which evaluate accusations of abuse and neglect of children and vulnerable adults.” AIDD considered this comment, but notes that other government oversight entities may not be able to investigate instances of abuse/neglect in a timely fashion as a result of limited resources. For example, Congress created the P&A system, to, among other responsibilities, investigate abuse and neglect and to take appropriate steps to protect and advocate for individuals with developmental disabilities, 42 U.S.C. 15043(a)(2)(A), (B) and (G). Congress has also explicitly recognized that P&As may learn of abuse and neglect by monitoring service providers, 42 U.S.C. 15043(a)(2)(L)(ii)(III). Again, the DD Act does not carve out exceptions for a category of care facilities or service providers, even in cases where services may be provided in a private home. P&As must not be constrained in carrying out their statutory mandate to protect individuals with developmental disabilities from abuse or neglect, and must not have their investigation and monitoring efforts hampered based on the responsiveness and timeliness of other government agencies or authorities. With respect to § 1386.28(b)(2), AIDD added the term “disposal” to the list of required written policies regarding information from client records to help ensure the protection of confidentiality and help ensure the prevention of inappropriate or unintentional disclosure of such information. The addition of “disposal” conforms to prudent modern data management practices. Subpart D—Federal Assistance to State Councils on Developmental Disabilities The final rule redesignates subpart C as subpart D and revises the material to update statutory and U.S. Code citations to conform to the Developmental Disabilities Act of 2000 and update the wording of the State Councils on Developmental Disabilities. Section 1386.30 State Plan Requirements The NPRM placed a five year time limit on demonstration projects to coincide with the State Plan submission and approval process, as well as to ensure consistency with the Act (42 U.S.C. 125(c)(5)(K)(i) and (ii)). A number of commenters relayed concerns that a five year time limit on demonstration projects would have unintended consequences. For example, Web sites, employment activities, self-advocacy activities and programs such as Partners in Policymaking could be impacted. Therefore, AIDD has modified paragraphs (e) and (f) so that States desiring to receive assistance beyond five years, under this subtitle, shall include, in the State plan, the estimated period for the project's continued duration, justification of why the project cannot be funded by the State, other public or private sources of funding, justification as to why a project receive continued funding, and intention to provide data outcomes showing evidence of success. Councils must also develop and include strategies to locate on-going funding from other sources after five years. AIDD clarified in paragraphs (e) that it reserves the right as the overseeing agency to deny the continuation of demonstration projects past five years. Although no adverse comments were received on paragraph (f), AIDD has amended this section to make it consistent with section 124(a)(5) of the Act (42 U.S.C. 15024). Section 1386.31 State Plan Submittal and Approval Although we received no adverse comments on paragraph (a), we are making technical changes to the proposed regulation to provide examples of formats accessible to individuals with developmental disabilities and the general public to reflect current technology. AIDD chose not to finalize the requirement in § 1386.31(b) that, “the State plan or amendment must be approved by the entity or individual authorized to do so under State law.” We did not finalize this because it is not a requirement under the Act and could potentially create conflict with the law in section 124(c)(5)(L) that requires a State not interfere with the State plan development or implementation. Section 1386.33 Protection of Employee Interests Commenters requested clarification that the State would be responsible for the protection of employees who are displaced by institutional closures rather than the operator of the institution. AIDD has not made any changes to this section as the NPRM clearly states that specific arrangements for the protection of affected employees must be developed through negotiations between the State authorities and employees or their representatives. Section 1386.34 Designated State Agency No comments were received however technical changes we made to reflect the move of AIDD to ACL. Section 1386.35 Allowable and Non-Allowable Costs for Federal Assistance to State Councils on Developmental Disabilities Some respondents requested that § 1386.35 be revised to allow for State Councils on Developmental Disabilities' rapid response to the emergency needs of impacted citizens such as those affected by a national disaster or time of war. While we appreciate the comments received, AIDD does not find it necessary to make changes to this section. Under the existing law, the State Councils on Developmental Disabilities can use their funding to work with emergency responders to assist them with planning for the support needs of individuals with developmental disabilities in the event of a national disaster or time of war. Section 1386.36 Final Disapproval of the State Plan or Plan Amendments No comments were received however AIDD has made technical changes to reflect the move of AIDD to ACL. Sections 1386.80 through 1386.112 Subpart E—Practice and Procedure for Hearings Pertaining to State's Conformity and Compliance With Developmental Disabilities State Plans, Reports and Federal Requirements, Formerly Subpart D No comments were received; however, AIDD has made technical changes to reflect the move of AIDD to ACL and related delegations. Part 1387—Projects of National Significance Section 1387.1 General Requirements No comments were received on this section of the NPRM. However, AIDD made an administrative change and removed § 1387.1(b) as PNS program announcements are not required by the Act to be published in the Federal Register . Part 1388—National Network of University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDS) Significant changes were made to part 1388 from the NPRM based on comments received. Section 153(a)(1) of the Act directed the Secretary to define the term “UCEDD”. The NPRM removed language from previous regulations that defined the term University Affiliated Program, which was the previous name of the program. Many of the comments asked AIDD to define what a UCEDD is. The previous term “University Affiliated Program” was defined in previous regulations, but the new term “UCEDD” was not defined in the 2008 NPRM. We reviewed the comments and concurred that a clear definition for the UCEDD is necessary. To that end, part 1388 has been reorganized, and language for Governance and Administration has been restored from the previously published regulations. Section 1388.1 Definitions As a technical correction AIDD added the definition of “State” to part 1388 so that it matches the statute. Under Subtitle D, section 155, the statutory definition of “State” that applies to UCEDDs differs from the definition of “State” in the rest of the Act. Section 1388.2 Purpose In paragraph (a)(2), the wording “(as defined by the Secretary)” was removed because AIDD has defined a UCEDD, in § 1388.6, in response to comments received. Section 1388.3 Core Functions This section was renumbered from § 1388.2 to § 1388.3. No other changes were made. Section 1388.4 National Training Initiatives on Critical and Emerging Needs This section was renumbered from § 1388.3 to § 1388.4. No other changes were made. Section 1388.5 Applications This section was renumbered from § 1388.4 to § 1388.5. Additional technical changes were made. Section 1388.6 Governance and Administration In the NPRM, this language had been deleted. Many commenters disagreed with the deletion, expressing concern that the elimination of this language would undermine the effectiveness of the UCEDD programs and allow for diversion of funds for inappropriate purposes. AIDD concurred with the commenters and has restored the original regulatory language prescribing the governance and administration of UCEDDs. Section 1388.7 Five-Year Plan and Annual Report This section was renumbered from § 1388.5 to § 1388.7. Amended regulations: 45 CFR parts 1385, 1386, 1387, and 1388. In 2008, a Notice of Proposed Rulemaking was promulgated by the Administration on Intellectual and Developmental Disabilities. This final rule presents 45 CFR parts 1385, 1386, 1387, and 1388 as amended in their entirety. IV. Impact Analysis A. Executive Order 12866 Executive Order 12866 requires that regulations be drafted to ensure that they are consistent with the priorities and principles set forth in Executive Order 12866. The Department has determined that this rule is consistent with these priorities and principles. Executive Order 12866 encourages agencies, as appropriate, to provide the public with meaningful participation in the regulatory process. The rule implements the Developmental Disabilities Act of 2000. In developing the final rule, we considered input we received from the public including stakeholders. B. Regulatory Flexibility Analysis The Secretary certifies under 5 U.S.C. 605(b), the Regulatory Flexibility Act (Pub. L. 96-354), that this regulation will not have a significant economic impact on a substantial number of small entities. The primary impact of this regulation is on State Councils on Developmental Disabilities (SCDDs), State Protection and Advocacy Systems (P&As), and University Centers of Excellence in Developmental Disabilities (UCEDDs). This final rule will support the work of the P&As in investigating potential abuse and neglect by providing guidance regarding access to service providers and records of individuals. Service providers will be impacted if a complaint is made against them. Similarly, this regulation will support the work of UCEDDs by providing guidance on the administration and operation standards of the programs. The regulation does not have a significant economic impact on these entities. AIDD estimates an impact of less than $100,000 across the DD entities. C. Paperwork Reduction Act of 1995 Sections 1386.22, 1386.32, and 1388.5 contain information collection requirements. In part 1386 of the NPRM, the State Council on Developmental Disabilities Program Performance Report and the Protection and Advocacy Statement of Goals and Priorities required renewal from OMB. Reporting and Recordkeeping Requirements in Part 1386 and 1388 of the Final Rule Expires Annual # of respondents Ave. burden response Annual burden hours 1386.23(a) SF-PPR 0980-0027 08/31/2017 57 44 hours 2,508 1386.23(c) P&A SGP Reinstatement 0980-0270 11/30/2015 57 44 hours 2,508 1386.30(c) Council State Plan 0980-0029 11/30/2017 56 367 hours 20,552 1386.32(b) Council PPR Reinstatement 0980-0172 08/31/2015 56 138 hours 7,728 1386 32(a) Council Financial Status Report (AIDD-02B) AIDD-02 Council 0985-0026 11/30/2015 56 8 hours 842 1388.5(b) UCEDD Annual Report 0970-0289 09/30/2016 67 1,412 hours 94,604 D. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) requires that a covered agency prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in expenditures by State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million, adjusted for inflation, or more in any one year. If a covered agency must prepare a budgetary impact statement, section 205 further requires that it select the most cost-effective and least burdensome alternatives that achieves the objectives of the rule and is consistent with the statutory requirements. In addition, section 203 requires a plan for informing and advising any small government that may be significantly or uniquely impacted by a rule. AIDD has determined that this rule does not result in the expenditure by State, local, and Tribal government in the aggregate, or by the private sector of more than $100 million in any one year. E. Congressional Review This rule is not a major rule as defined in 5 U.S.C. 804(2). F. Assessment of Federal Regulations and Policies on Families Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal agencies to determine whether a policy or regulation may affect family well-being. If the agency's conclusion is affirmative, then the agency must prepare an impact assessment addressing seven criteria specified in the law. These regulations do not have an impact on family well-being as defined in the legislation. G. Executive Order 13132 Executive Order 13132 on “federalism” was signed August 4, 1999. The purposes of the Order are: “. . . to guarantee the division of governmental responsibilities between the national government and the States that was intended by the Framers of the Constitution, to ensure that the principles of federalism established by the Framers guide the executive departments and agencies in the formulation and implementation of policies, and to further the policies of the Unfunded Mandates Reform Act. . .” The Department certifies that this rule does not have a substantial direct effect on States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. AIDD is not aware of any specific State laws that would be preempted by the adoption of the regulation in subpart C of 45 CFR part 1386. This rule does contain regulatory policies with federalism implications that require specific consultation with State or local elected officials. However, prior to the development of the rule, the Administration on Intellectual and Developmental Disabilities consulted with SCDDs, P&As, and UCEDDs to minimize any substantial direct effect on them and indirectly on States. List of Subjects 45 CFR Part 1385 Disabled, Grant programs—education, Grant program—social programs, Reporting and recordkeeping requirements 45 CFR Part 1386 Administrative practice and procedures, Grant programs—education, Grant programs—social programs, Individuals with disabilities, Reporting and recordkeeping requirements. 45 CFR Part 1387 Administration practice and procedures, Grant programs—education, Grant programs—social programs, Individuals with disabilities. 45 CFR Part 1388 Colleges and universities, Grant programs—education, Grant programs—social programs, Individuals with disabilities, Research. Dated: July 16, 2015. Kathy Greenlee, Administrator, Administration for Community Living, Assistant Secretary for Aging, Administration on Aging. Approved: July 17, 2015. Sylvia M. Burwell, Secretary. Regulation Text For reasons set forth in the preamble, under the authority of 42 U.S.C. 15001 et seq., the Department of Health and Human Services revises subchapter I, chapter XIII, of title 45 of the Code of Federal Regulations to read as set forth below: CHAPTER XIII—OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subchapter I—The Administration on Intellectual and Developmental Disabilities, Developmental Disabilities Program PART 1385—REQUIREMENTS APPLICABLE TO THE DEVELOPMENTAL DISABILITIES PROGRAM 1386—FORMULA GRANT PROGRAMS 1387—PROJECTS OF NATIONAL SIGNIFICANCE 1388—THE NATIONAL NETWORK OF UNIVERSITY CENTERS FOR EXCELLENCE IN DEVELOPMENTAL DISABILITIES, EDUCATION, RESEARCH, AND SERVICE Subchapter I—The Administration on Intellectual and Developmental Disabilities, Developmental Disabilities Program PART 1385—REQUIREMENTS APPLICABLE TO THE DEVELOPMENTAL DISABILITIES PROGRAM Sec. 1385.1 General. 1385.2 Purpose of the regulations. 1385.3 Definitions. 1385.4 Rights of individuals with developmental disabilities. 1385.5 [Reserved] 1385.6 Employment of individuals with disabilities. 1385.7 Reports to the Secretary. 1385.8 Formula for determining allotments. 1385.9 Grants administration requirements. Authority: 42 U.S.C. 15001 et seq. § 1385.1 General. Except as specified in § 1385.4, the requirements in this part are applicable to the following programs and projects: (a) Federal Assistance to State Councils on Developmental Disabilities; (b) Protection and Advocacy for Individuals with Developmental Disabilities; (c) Projects of National Significance; and (d) National Network of University Centers for Excellence in Developmental Disabilities Education, Research, and Service. § 1385.2 Purpose of the regulations. These regulations implement the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 et seq. ). § 1385.3 Definitions. For the purposes of parts 1385 through 1388 of this chapter, the following definitions apply: ACL. The term “ACL” means the Administration for Community Living within the U.S. Department of Health and Human Services. Act. The term “Act” means the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000) (42 U.S.C. 15001 et seq. ). Accessibility. The term “Accessibility” means that programs funded under the DD Act of 2000 and facilities which are used in those programs meet applicable requirements of section 504 of the Rehabilitation Act of 1973 (Pub. L. 93-112), its implementing regulation, 45 CFR part 84, the Americans with Disabilities Act of 1990, as amended , Title VI of the Civil Rights Act of 1964 (Pub. L. 88-352), and its implementing regulation, 45 CFR part 80. (1) For programs funded under the DD Act of 2000, information shall be provided to applicants and program participants in plain language and in a manner that is accessible and timely to: (i) Individuals with disabilities, including accessible Web sites and the provision of auxiliary aids and services at no cost to the individual; and (ii) Individuals who are limited English proficient through the provision of language services at no cost to the individual, including: (A) Oral interpretation; (B) Written translations; and (C) Taglines in non-English languages indicating the availability of language services. AIDD. The term “AIDD” means the Administration on Intellectual and Developmental Disabilities, within the Administration for Community Living at the U.S. Department of Health and Human Services. Advocacy activities. The term “advocacy activities” means active support of policies and practices that promote systems change efforts and other activities that further advance self-determination and inclusion in all aspects of community living (including housing, education, employment, and other aspects) for individuals with developmental disabilities, and their families. Areas of emphasis. The term “areas of emphasis” means the areas related to quality assurance activities, education activities and early intervention activities, child care-related activities, health-related activities, employment-related activities, housing-related activities, transportation-related activities, recreation-related activities, and other services available or offered to individuals in a community, including formal and informal community supports that affect their quality of life. Assistive technology device. The term “assistive technology device” means any item, piece of equipment, or product system, whether acquired commercially, modified or customized, that is used to increase, maintain, or improve functional capabilities of individuals with developmental disabilities. Assistive technology service. The term “assistive technology service” means any service that directly assists an individual with a developmental disability in the selection, acquisition, or use of an assistive technology device. Such term includes: Conducting an evaluation of the needs of an individual with a developmental disability, including a functional evaluation of the individual in the individual's customary environment; purchasing, leasing, or otherwise providing for the acquisition of an assistive technology device by an individual with a developmental disability; selecting, designing, fitting, customizing, adapting, applying, maintaining, repairing or replacing an assistive technology device; coordinating and using another therapy, intervention, or service with an assistive technology device, such as a therapy, intervention, or service associated with an education or rehabilitation plan or program; providing training or technical assistance for an individual with a developmental disability, or, where appropriate, a family member, guardian, advocate, or authorized representative of an individual with a developmental disability; and providing training or technical assistance for professionals (including individuals providing education and rehabilitation services), employers, or other individuals who provide services to, employ, or are otherwise substantially involved in the major life functions of, an individual with developmental disabilities. Capacity building activities. The term “capacity building activities” means activities ( e.g. training and technical assistance) that expand and/or improve the ability of individuals with developmental disabilities, families, supports, services and/or systems to promote, support and enhance self-determination, independence, productivity and inclusion in community life. Center. The term “Center” means a University Center for Excellence in Developmental Disabilities Education, Research, and Service (UCEDD) established under subtitle D of the Act. Child care-related activities. The term “child care-related activities” means advocacy, capacity building, and systemic change activities that result in families of children with developmental disabilities having access to and use of child care services, including before-school, after-school, and out-of-school services, in their communities. Culturally competent. The term “culturally competent,” used with respect to services, supports, and other assistance means that services, supports, or other assistance that are conducted or provided in a manner that is responsive to the beliefs, interpersonal styles, attitudes, language, and behaviors of individuals who are receiving the services, supports or other assistance, and in a manner that has the greatest likelihood of ensuring their maximum participation in the program involved. Department. The term “Department” means the U.S. Department of Health and Human Services. Developmental disability. The term “developmental disability” means a severe, chronic disability of an individual that: (1) Is attributable to a mental or physical impairment or combination of mental and physical impairments; (2) Is manifested before the individual attains age 22; (3) Is likely to continue indefinitely; (4) Results in substantial functional limitations in three or more of the following areas of major life activity: (i) Self-care; (ii) Receptive and expressive language; (iii) Learning; (iv) Mobility; (vi) Self-direction; (vii) Capacity for independent living; and (viii) Economic self-sufficiency. (5) Reflects the individual's need for a combination and sequence of special, interdisciplinary or generic services, individualized supports, or other forms of assistance that are of lifelong or extended duration and are individually planned and coordinated. (6) An individual from birth to age nine, inclusive, who has a substantial developmental delay or specific congenital or acquired condition, may be considered to have a developmental disability without meeting three or more of the criteria described in paragraphs (1) through (5) of this definition, if the individual, without services and supports, has a high probability of meeting those criteria later in life. Early intervention activities. The term “early intervention activities” means advocacy, capacity building, and systemic change activities provided to infants and young children described in the definition of “developmental disability” and their families to enhance the development of the individuals to maximize their potential, and the capacity of families to meet the special needs of the individuals. Education activities. The term “education activities” means advocacy, capacity building, and systemic change activities that result in individuals with developmental disabilities being able to access appropriate supports and modifications when necessary, to maximize their educational potential, to benefit from lifelong educational activities, and to be integrated and included in all facets of student life. Employment-related activities. The term “employment-related activities” means advocacy, capacity building, and systemic change activities that result in individuals with developmental disabilities acquiring, retaining, or advancing in paid employment, including supported employment or self-employment, in integrated settings in a community. Family support services. The term “family support services” means services, supports, and other assistance, provided to families with a member or members who have developmental disabilities, that are designed to: Strengthen the family's role as primary caregiver; prevent inappropriate out-of-the-home placement of the members and maintain family unity; and reunite, whenever possible, families with members who have been placed out of the home. This term includes respite care, provision of rehabilitation technology and assistive technology, personal assistance services, parent training and counseling, support for families headed by aging caregivers, vehicular and home modifications, and assistance with extraordinary expenses associated with the needs of individuals with developmental disabilities. Fiscal year. The term “fiscal year” means the Federal fiscal year unless otherwise specified. Governor. The term “Governor” means the chief executive officer of a State, as that term is defined in the Act, or his or her designee who has been formally designated to act for the Governor in carrying out the requirements of the Act and the regulations. Health-related activities. The term “health-related activities” means advocacy, capacity building, and systemic change activities that result in individuals with developmental disabilities having access to and use of coordinated health, dental, mental health, and other human and social services, including prevention activities, in their communities. Housing-related activities. The term “housing-related activities” means advocacy, capacity building, and systemic change activities that result in individuals with developmental disabilities having access to and use of housing and housing supports and services in their communities, including assistance related to renting, owning, or modifying an apartment or home. Inclusion. The term “inclusion”, used with respect to individuals with developmental disabilities, means the acceptance and encouragement of the presence and participation of individuals with developmental disabilities, by individuals without disabilities, in social, educational, work, and community activities, that enable individuals with developmental disabilities to have friendships and relationships with individuals and families of their own choice; live in homes close to community resources, with regular contact with individuals without disabilities in their communities; enjoy full access to and active participation in the same community activities and types of employment as individuals without disabilities; and take full advantage of their integration into the same community resources as individuals without disabilities, living, learning, working, and enjoying life in regular contact with individuals without disabilities. Individualized supports. The term “individualized supports” means supports that: Enable an individual with a developmental disability to exercise self-determination, be independent, be productive, and be integrated and included in all facets of community life; designed to enable such individual to control such individual's environment, permitting the most independent life possible; and prevent placement into a more restrictive living arrangement than is necessary and enable such individual to live, learn, work, and enjoy life in the community; and include early intervention services, respite care, personal assistance services, family support services, supported employment services support services for families headed by aging caregivers of individuals with developmental disabilities, and provision of rehabilitation technology and assistive technology, and assistive technology services. Integration. The term “integration,” means exercising the equal rights of individuals with developmental disabilities to access and use the same community resources as are used by and available to other individuals. Not-for-profit. The term “not-for-profit,” used with respect to an agency, institution or organization, means an agency, institution, or organization that is owned or operated by one or more corporations or associations, no part of the net earnings of which injures, or may lawfully inure, to the benefit of any private shareholder or individual. Personal assistance services. The term “personal assistance services” means a range of services provided by one or more individuals designed to assist an individual with a disability to perform daily activities, including activities on or off a job, that such individual would typically perform if such individual did not have a disability. Such services shall be designed to increase such individual's control in life and ability to perform everyday activities, including activities on or off a job. Prevention activities. The term “prevention activities” means activities that address the causes of developmental disabilities and the exacerbation of functional limitation, such as activities that: Eliminate or reduce the factors that cause or predispose individuals to developmental disabilities or that increase the prevalence of developmental disabilities; increase the early identification of problems to eliminate circumstances that create or increase functional limitations; and mitigate against the effects of developmental disabilities throughout the lifespan of an individual. Productivity. The term “productivity” means engagement in income-producing work that is measured by increased income, improved employment status, or job advancement, or engagement in work that contributes to a household or community. Protection and Advocacy (P&A) Agency. The term “Protection and Advocacy (P&A) Agency” means a protection and advocacy system established in accordance with section 143 of the Act. Quality assurance activities. The term “quality assurance activities” means advocacy, capacity building, and systemic change activities that result in improved consumer and family-centered quality assurance and that result in systems of quality assurance and consumer protection that include monitoring of services, supports, and assistance provided to an individual with developmental disabilities that ensures that the individual will not experience abuse, neglect, sexual or financial exploitation, or violation of legal or human rights; and will not be subject to the inappropriate use of restraints or seclusion; include training in leadership, self-advocacy, and self-determination for individuals with developmental disabilities, their families, and their guardians to ensure that those individuals will not experience abuse, neglect, sexual or financial exploitation, or violation of legal or human rights; and will not be subject to the inappropriate use of restraints or seclusion; or include activities related to interagency coordination and systems integration that result in improved and enhanced services, supports, and other assistance that contribute to and protect the self-determination, independence, productivity, and integration and inclusion in all facets of community life of individuals with developmental disabilities. Rehabilitation technology. The term “rehabilitation technology” means the systematic application of technologies, engineering methodologies, or scientific principles to meet the needs of, and address the barriers confronted by individuals with developmental disabilities in areas that include education, rehabilitation, employment, transportation, independent living, and recreation. Such term includes rehabilitation engineering, and the provision of assistive technology devices and assistive technology services. Required planning documents. The term “required planning documents” means the State plans required by § 1386.30 of this chapter for the State Council on Developmental Disabilities, the Annual Statement of Goals and Priorities required by § 1386.22(c) of this chapter for P&As, and the five-year plan and annual report required by § 1388.7 of this chapter for UCEDDs. Secretary. The term “Secretary” means the Secretary of the U.S. Department of Health and Human Services. Self-determination activities. The term “self-determination activities” means activities that result in individuals with developmental disabilities, with appropriate assistance, having the ability and opportunity to communicate and make personal decisions; the ability and opportunity to communicate choices and exercise control over the type and intensity of services, supports, and other assistance the individuals receive; the authority to control resources to obtain needed services, supports, and other assistance; opportunities to participate in, and contribute to, their communities; and support, including financial support, to advocate for themselves and others to develop leadership skills through training in self-advocacy to participate in coalitions, to educate policymakers, and to play a role in the development of public policies that affect individuals with developmental disabilities. State. The term “State”: (1) Except as applied to the University Centers of Excellence in Developmental Disabilities Education, Research and Service in section 155 of the Act, includes each of the several States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. (2) For the purpose of UCEDDs in section 155 of the Act and part 1388 of this chapter, “State” means each of the several States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, and Guam. State Council on Developmental Disabilities (SCDD). The term “State Council on Developmental Disabilities (SCDD)” means a Council established under section 125 of the DD Act. Supported employment services. The term ”supported employment services” means services that enable individuals with developmental disabilities to perform competitive work in integrated work settings, in the case of individuals with developmental disabilities for whom competitive employment has not traditionally occurred; or for whom competitive employment has been interrupted or intermittent as a result of significant disabilities; and who, because of the nature and severity of their disabilities, need intensive supported employment services or extended services in order to perform such work. Systemic change activities. The term “systemic change activities” means a sustainable, transferable and replicable change in some aspect of service or support availability, design or delivery that promotes positive or meaningful outcomes for individuals with developmental disabilities and their families. Transportation-related activities. The term “transportation-related activities” means advocacy, capacity building, and systemic change activities that result in individuals with developmental disabilities having access to and use of transportation. UCEDD. The term “UCEDD” means University Centers for Excellence in Developmental Disabilities Education, Research, and Service, also known by the term “Center” under section 102(5) of the Act. Unserved and underserved. The term “unserved and underserved” includes populations such as individuals from racial and ethnic minority backgrounds, disadvantaged individuals, individuals with limited English proficiency, individuals from underserved geographic areas (rural or urban), and specific groups of individuals within the population of individuals with developmental disabilities, including individuals who require assistive technology in order to participate in community life. § 1385.4 Rights of individuals with developmental disabilities. (a) Section 109 of the Act, Rights of Individuals with Developmental Disabilities (42 U.S.C. 15009), is applicable to the SCDD. (b) In order to comply with section 124(c)(5)(H) of the Act (42 U.S.C. 15024(c)(5)(H)), regarding the rights of individuals with developmental disabilities, the State participating in the SCDD program must meet the requirements of 45 CFR 1386.30(f). (c) Applications from UCEDDs also must contain an assurance that the human rights of individuals assisted by this program will be protected consistent with section 101(c) (see section 154(a)(3)(D) of the Act). § 1385.5 [Reserved] § 1385.6 Employment of individuals with disabilities. Each grantee which receives Federal funding under the Act must meet the requirements of section 107 of the Act (42 U.S.C. 15007) regarding affirmative action. The grantee must take affirmative action to employ and advance in employment and otherwise treat qualified individuals with disabilities without discrimination based upon their physical or mental disability in all employment practices such: Advertising, recruitment, employment, rates of pay or other forms of compensation, selection for training, including apprenticeship, upgrading, demotion or transfer, and layoff or termination. This obligation is in addition to the requirements of 45 CFR part 84, subpart B, prohibiting discrimination in employment practices on the basis of disability in programs receiving assistance from the Department. Recipients of funds under the Act also may be bound by the provisions of the Americans with Disabilities Act of 1990 (Pub. L. 101-336, 42 U.S.C. 12101 et seq. ) with respect to employment of individuals with disabilities. Failure to comply with section 107 of the Act may result in loss of Federal funds under the Act. If a compliance action is taken, the State will be given reasonable notice and an opportunity for a hearing as provided in subpart E of 45 CFR part 1386. § 1385.7 Reports to the Secretary. All grantee submission of plans, applications and reports must label goals, activities and results clearly in terms of the following: Area of emphasis, type of activity (advocacy, capacity building, systemic change), and categories of measures of progress. § 1385.8 Formula for determining allotments. The Secretary, or his or her designee, will allocate funds appropriated under the Act for the State Councils on Developmental Disabilities and the P&As as directed in sections 122 and 142 of the Act (42 U.S.C. 15022 and 15042). § 1385.9 Grants administration requirements. (a) The following parts of this title and title 2 CFR apply to grants funded under parts 1386 and 1388 of this chapter, and to grants for Projects of National Significance under section 162 of the Act (42 U.S.C. 15082): (1) 45 CFR part 16—Procedures of the Departmental Grant Appeals Board. (2) 45 CFR part 46—Protection of Human Subjects. (3) 45 CFR part 75—Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Award. (4) 2 CFR part 376—Nonprocurement Debarment and Suspension. (5) 45 CFR part 80—Nondiscrimination under Programs Receiving Federal Assistance through the Department of Health and Human Services Effectuation of title VI of the Civil Rights Act of 1964. (5) 45 CFR part 81—Practice and Procedure for Hearings under part 80 of this title. (6) 45 CFR part 84—Nondiscrimination on the Basis of Handicap in Programs and Activities Receiving Federal Financial Assistance. (7) 45 CFR part 86—Nondiscrimination on the Basis of Sex in Education Programs and Activities Receiving Federal Financial Assistance. (8) 45 CFR part 91—Nondiscrimination on the Basis of Age in Programs or Activities Receiving Federal Financial Assistance from HHS. (9) 45 CFR part 93—New Restrictions on Lobbying. (b) The Departmental Appeals Board also has jurisdiction over appeals by any grantee that has received grants under the UCEDD programs or for Projects of National Significance. The scope of the Board's jurisdiction concerning these appeals is described in 45 CFR part 16. (c) The Departmental Appeals Board also has jurisdiction to decide appeals brought by the States concerning any disallowances taken by the Secretary, or his or her designee, with respect to specific expenditures incurred by the States or by contractors or sub grantees of States. This jurisdiction relates to funds provided under the two formula programs—subtitle B of the Act—Federal Assistance to State Councils on Developmental Disabilities, and subtitle C of the Act—Protection and Advocacy for Individuals with Developmental Disabilities. Appeals filed by States shall be decided in accordance with 45 CFR part 16. (d) In making audits and examination to any books, documents, papers, and transcripts of records of SCDDs, the P&As, the UCEDDs and the Projects of National Significance grantees and sub grantees, as provided for in 45 CFR part 75, the Department will keep information about individual clients confidential to the maximum extent permitted by law and regulations. (e)(1) The Department or other authorized Federal officials may access client and case eligibility records or other records of a P&A system for audit purposes, and for purposes of monitoring system compliance pursuant to section 103(b) of the Act. However, such information will be limited pursuant to section 144(c) of the Act. No personal identifying information such as name, address, and social security number will be obtained. Only eligibility information will be obtained regarding the type and level of disability of individuals being served by the P&A and the nature of the issue concerning which the system represented an individual. (2) Notwithstanding paragraph (e)(1) of this section, if an audit, monitoring review, evaluation, or other investigation by the Department produces evidence that the system has violated the Act or the regulations, the system will bear the burden of proving its compliance. The system's inability to establish compliance because of the confidentiality of records will not relieve it of this responsibility. The P&A may elect to obtain a release regarding personal information and privacy from all individuals requesting or receiving services at the time of intake or application. The release shall state that only information directly related to client and case eligibility will be subject to disclosure to officials of the Department. PART 1386—FORMULA GRANT PROGRAMS Subpart A—Basic Requirements Sec. 1386.1 General. 1386.2 Obligation of funds. 1386.3 Liquidation of obligations. 1386.4 [Reserved] Subpart B—Protection and Advocacy for Individuals With Developmental Disabilities (PADD) 1386.19 Definitions. 1386.20 Agency designated as the State Protection and Advocacy System. 1386.21 Requirements and authority of the State Protection and Advocacy System. 1386.22 Periodic reports: State Protection and Advocacy System. 1386.23 Non-allowable costs for the State Protection and Advocacy System. 1386.24 Allowable litigation costs. Subpart C—Access to Records, Service Providers, and Individuals With Developmental Disabilities 1386.25 Access to records. 1386.26 Denial or delay of access to records. 1386.27 Access to service providers and individuals with developmental disabilities. 1386.28 Confidentiality of State Protection and Advocacy System records. Subpart D—Federal Assistance to State Councils on Developmental Disabilities 1386.30 State plan requirements. 1386.31 State plan submittal and approval. 1386.32 Periodic reports: Federal assistance to State Councils on Developmental Disabilities. 1386.33 Protection of employees interest. 1386.34 Designated State Agency. 1386.35 Allowable and non-allowable costs for Federal assistance to State Councils on Developmental Disabilities. 1386.36 Final disapproval of the State plan or plan amendments. Subpart E—Practice and Procedure for Hearings Pertaining to States' Conformity and Compliance With Developmental Disabilities State Plans, Reports, and Federal Requirements General 1386.80 Definitions. 1386.81 Scope of rules. 1386.82 Records to the public. 1386.83 Use of gender and number. 1386.84 Suspension of rules. 1386.85 Filling and service of papers. Preliminary Matters—Notice and Parties 1386.90 Notice of hearing or opportunity for hearing. 1386.91 Time of hearing. 1386.92 Place. 1386.93 Issues at hearing. 1386.94 Request to participate in hearing. Hearing Procedures 1386.100 Who presides. 1386.101 Authority of presiding officer. 1386.102 Rights of parties. 1386.103 Discovery. 1386.104 Evidentiary purpose. 1386.105 Evidence. 1386.106 Exclusion from hearing for misconduct. 1386.107 Unsponsored written material. 1386.108 Official transcript. 1386.109 Record for decision. Post-Hearing Procedures, Decisions 1386.110 Post-hearing briefs. 1386.111 Decisions following hearing. 1386.112 Effective date of decision by the Secretary. Authority: 42 U.S.C. 15001 et seq. Subpart A—Basic Requirements § 1386.1 General. All rules under this subpart are applicable to both the State Councils on Developmental Disabilities and the agency designated as the State Protection and Advocacy (P&As) System. § 1386.2 Obligation of funds. (a) Funds which the Federal Government allots under this part during a Federal fiscal year are available for obligation by States for a two-year period beginning with the first day of the Federal fiscal year in which the grant is awarded. (b)(1) A State incurs an obligation for acquisition of personal property or for the performance of work on the date it makes a binding, legally enforceable, written commitment, or when the State Council on Developmental Disabilities enters into an Interagency Agreement with an agency of State government for acquisition of personal property or for the performance of work. (2) A State incurs an obligation for personal services, for services performed by public utilities, for travel or for rental of real or personal property on the date it receives the services, its personnel takes the travel, or it uses the rented property. (c)(1) A Protection & Advocacy System may elect to treat entry of an appearance in judicial and administrative proceedings on behalf of an individual with a developmental disability as a basis for obligating funds for the litigation costs. The amount of the funds obligated must not exceed a reasonable estimate of the costs, and the way the estimate was calculated must be documented. (2) For the purpose of this paragraph (c), litigation costs means expenses for court costs, depositions, expert witness fees, travel in connection with a case and similar costs, and costs resulting from litigation in which the agency has represented an individual with developmental disabilities ( e.g., monitoring court orders, consent decrees), but not for salaries of employees of the P&A. All funds made available for Federal assistance to State Councils on Developmental Disabilities and to the P&As obligated under this paragraph (c) are subject to the requirement of paragraph (a) of this section. These funds, if reobligated, may be reobligated only within a two-year period beginning with the first day of the Federal fiscal year in which the funds were originally awarded. § 1386.3 Liquidation of obligations. (a) All obligations incurred pursuant to a grant made under the Act for a specific Federal fiscal year, must be liquidated within two years of the close of the Federal fiscal year in which the grant was awarded. (b) The Secretary, or his or her designee, may waive the requirements of paragraph (a) of this section when State law impedes implementation or the amount of obligated funds to be liquidated is in dispute. (c) Funds attributable to obligations which are not liquidated in accordance with the provisions of this section revert to the Federal Government. § 1386.4 [Reserved] Subpart B—Protection and Advocacy for Individuals With Developmental Disabilities (PADD) § 1386.19 Definitions. As used in this subpart and subpart C of this part, the following definitions apply: Abuse. The term “abuse” means any act or failure to act which was performed, or which was failed to be performed, knowingly, recklessly, or intentionally, and which caused, or may have caused, injury or death to an individual with developmental disabilities, and includes but is not limited to such acts as: Verbal, nonverbal, mental and emotional harassment; rape or sexual assault; striking; the use of excessive force when placing such an individual in bodily restraints; the use of bodily or chemical restraints which is not in compliance with Federal and State laws and regulations, or any other practice which is likely to cause immediate physical or psychological harm or result in long term harm if such practices continue. In addition, the P&A may determine, in its discretion that a violation of an individual's legal rights amounts to abuse, such as if an individual is subject to significant financial exploitation. American Indian Consortium. The term “American Indian Consortium” means any confederation of 2 or more recognized American Indian Tribes, created through the official resident population of 150,000 enrolled tribal members and a contiguous territory of Indian lands in two or more States. Complaint. The term “complaint” includes, but is not limited to, any report or communication, whether formal or informal, written or oral, received by the P&A system, including media accounts, newspaper articles, electronic communications, telephone calls (including anonymous calls) from any source alleging abuse or neglect of an individual with a developmental disability. Designating official. The term “designating official” means the Governor or other State official, who is empowered by the State legislature or Governor to designate the State official or public or private agency to be accountable for the proper use of funds by and conduct of the agency designated to administer the P&A system. Full investigation. The term “full investigation” means access to service providers, individuals with developmental disabilities and records authorized under these regulations, that are necessary for a P&A system to make a determination about whether alleged or suspected instances of abuse and neglect are taking place or have taken place. Full investigations may be conducted independently or in cooperation with other agencies authorized to conduct similar investigations. Legal guardian, Conservator, and Legal representative. The terms “legal guardian,” “conservator,” and “legal representative” all mean a parent of a minor, unless the State has appointed another legal guardian under applicable State law, or an individual appointed and regularly reviewed by a State court or agency empowered under State law to appoint and review such officers, and having authority to make all decisions on behalf of individuals with developmental disabilities. It does not include persons acting only as a representative payee, persons acting only to handle financial payments, executors and administrators of estates, attorneys or other persons acting on behalf of an individual with developmental disabilities only in individual legal matters, or officials or their designees responsible for the provision of services, supports, and other assistance to an individual with developmental disabilities. Neglect. The term “neglect” means a negligent act or omission by an individual responsible for providing services, supports or other assistance which caused or may have caused injury or death to an individual with a developmental disability(ies) or which placed an individual with developmental disability(ies) at risk of injury or death, and includes acts or omissions [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2015-18070. Public record. Not legal advice.