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Federal Register · Notice · Nov 29, 2010
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act … A license is required when the manufacture of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
75 FR 73101Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2015
Medical Device Recall Authority—21 CFR 810 (OMB Control Number 0910-0432)—Extension This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 … Request for Regulatory Hearing—810.11(a) 1 1 1 8 8 Written Request for Review—810.12(a-b) 1 1 1 8 8 Mandatory Recall Strategy—810.14 2 1 2 16 32 Periodic
80 FR 33523Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Apr 12, 2021
FDA-2011-N-0655] Animal Generic Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. … ; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's website.
86 FR 18986Health and Human Services DepartmentFood and Drug AdministrationAgency Emergency Processing Request Under OMB Review
Federal Register · Notice · Jun 11, 1998
This action is in response to provisions of the FDA Modernization Act of 1997 (FDAMA). DATES: Submit written comments on the collection of information by June 22, 1998. … The agency believes that this guidance will enable food producers to meet the criteria for notifications that are established in sections 403(r)(2)(G) and 403(r)(3)(C) of the act during the interim period
63 FR 32102Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 28, 2008
the Federal Food, Drug, and Cosmetic Act.” … To comply with this requirement, in the Federal Register of November 9, 2004 (69 FR 64962), FDA published a notice of availability of the draft guidance document providing a 60-day public comment period
73 FR 4875Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2015
The draft of this guidance was made available in the Federal Register on April 17, 2014 (79 FR 21777), and the comment period closed July 16, 2014. Only two sets of comments were received. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 49244Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2011
FDA is requesting public comment on estimates of annual submissions from these respondents, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462) and … Section 760(e) (21 U.S.C. 379aa(e)) of the FD&C Act also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of
76 FR 80946Health and Human Services DepartmentFood and Drug AdministrationMark Perkal; Grant of Special Termination; Final Order Terminating Debarment
Federal Register · Notice · Sep 11, 1998
Under section 306(d)(4)(D) of the act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Dr. … Perkal's period of debarment has lasted more than 1 year.
63 FR 48733Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 8, 2014
However, only one comment was PRA-related. (Comment) One comment was supportive of the information collection, stating that such “collections are, in fact, essential.” … Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period.
79 FR 72685Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 1999
Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193)-- Extension Section 10.85 (21 CFR 10.85), issued under section 701(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … In the Federal Register of September 28, 1999 (64 FR 52329), the agency requested comments on the proposed collection of information. No significant comments were received.
64 FR 73056Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 19, 2006
Background In the Federal Register of July 15, 2005 (70 FR 41043), FDA issued a notice of availability for, and an opportunity for public comment on, “The Mammography Quality Standards Act Final … During the public comment period, 6 respondents submitted a total of 38 comments.
71 FR 20111Health and Human Services DepartmentFood and Drug AdministrationAdministrative Practices and Procedures; Internal Agency Review of Decisions
Federal Register · Rule · Sep 23, 1998
, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … The comment period closed on August 31, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
63 FR 50757Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 31, 2023
Current Good Manufacturing Practice Regulations for Type A Medicated Articles—21 CFR Part 226 OMB Control Number 0910-0154—Extension Section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) … We review the records during the conduct of periodic plant inspections. This information is needed so that we can monitor drug usage and possible misformulation of Type A medicated articles.
88 FR 6281Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 6, 2004
The guidance responds to various questions raised about section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing … The agency is maintaining all responses to questions concerning food facility registration in a single document that is periodically updated as the agency responds to additional questions.
69 FR 47765Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Sep 30, 1997
DATES: Submit written comments on the collection of information by October 30, 1997. … Section 814.84 specifies the contents of periodic reports.
62 FR 51112Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 19, 2015
Specific Topics for Comment In addition to comments on the draft guidance as written, we are specifically requesting comments on the following issues: • Should the final guidance address the issue … It is only necessary to send one set of comments. Identify comments with Docket No. FDA-2015-D-1176.
80 FR 28624Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 30, 2020
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … We based our estimates in tables 1 and 2 on our experience with the MUMS indexing program and the requests for eligibility for indexing and for addition to the index, as well as the periodic drug experience
85 FR 23969Health and Human Services DepartmentFood and Drug AdministrationDavid Winne; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Aug 18, 2023
any drug product under the FD&C Act. … (7) of the FD&C Act).
88 FR 56636Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 13, 1998
The agency believes that this guidance will enable food producers to meet the criteria for notifications that are established in section 403(r)(2)(G) and (r)(3)(C) of the act during the interim period … while the agency is initiating notice-and-comment rulemaking in this matter.
63 FR 43400Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 7, 2005
the act. … To obtain this estimate, FDA averaged the number of requests for fast track designation received by CBER and CDER in the 3-year period from 2001 to 2003.
70 FR 33177Health and Human Services DepartmentFood and Drug Administration
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