# Agency Forms Undergoing Paperwork Reduction Act Review > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A95-16198 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** June 30, 1995 - **Citation:** 60 FR 34285 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency Forms Undergoing Paperwork Reduction Act Review Each Friday the Public Health Service (PHS) publishes a list of information collection requests under review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the PHS Reports Clearance Office on (202) 690- 7100. The following requests have been submitted for review since the list was last published on June 23. 1. National Health Services Corps Loan Repayment Program and the NHSC State Loan Repayment Program (42 CFR Part 62)--0915-0127-- Revision--Approval is requested for three data collections: Health professionals applying to the National Health Service Corps (NHSC) Loan Repayment Program (LRP), and holders of their loans, provide information needed to determine eligibility. NHSC LRP participants provide information annually on training status. States applying to the NHSC State LRP provide information needed to determine eligibility. Respondents: Individuals or households; Business or other-for-profit; State, Local or Tribal Government. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ NHSC/LRP........................ 1,000 1 1.5 Application..................... Lenders confirmation of loans... 1,600 1 .25 42 CFR 62.26 (b) (2) Training status documentation........... 1 1 1 *42 CFR 62.54 State Loan Repayment Program Application.. ........... .......... ............. [[Page 34286]] Estimated Total Annual Burden--1,901 hours ------------------------------------------------------------------------ * Burden carried with application--(OMB No. 0937-0189). 2. Community Partnership Demonstration Program National Evaluation: National Evaluation Survey and National Evaluation Survey for Supplemental Awards--New--Results from the National Evaluation Survey and Supplemental Awards Survey will be used by CSAP researchers to help assess the impact of the Community Partnership Demonstration Program on prevention outcomes. The surveys will be completed by partnership grantees. Respondents: Not-for-profit institutions; State, Local or Tribal Government. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ National Evaluation Survey...... 240 2 1.25 National Evaluation Survey for Supplemental Awards............ 87 1 0.5 Estimated Total Annual Burden--515 hours ------------------------------------------------------------------------ 3. Application for the Pharmacology Research Associate Program-- 0925-0378--Revision--The Pharmacology Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with a Ph.D. degree in pharmacology or a related science, M.D., or other professional degree through appointments as PRAT Fellows at the National Institutes of Health or Food and Drug Administration. The goal of the program is to develop leaders in pharmacological research for key positions in academic, industrial, and Federal research laboratories. Respondents: Individuals or households; Business or other for-profit. Send comments to James Scanlon, Office of the Assistant Secretary for health, Room 737-F, Humphrey Building, 200 Independence Ave., S.W. Washington, D.C. 20201. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ Applicants...................... 50 1 2.00 Referees........................ 150 1 .167 Estimated Total Annual Burden--125 hours ------------------------------------------------------------------------ 4. Tests and Requirements for Certification and Approval of Respiratory Protective Devices--42 CFR 84--0920-0109--Revision--NIOSH in accordance with regulations 42 CFR 84 certificates respirators. To implement these regulations NIOSH provides for the issuance by NIOSH/ MSHA of certificates of approval of respirators which meet specified construction performance, & protection requirements. Respondents: Business or other for-profit. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. ------------------------------------------------------------------------ Average No. of No. of burden/ respondents responses/ response respondent (hrs) ------------------------------------------------------------------------ Reporting: Application (42 CFR 84.11. 56 10.5 63.56 Modification (42 CFR 84.35).......... 56 10.5 79.45 Quality Control Plans (42 CFR 84.41). 56 10.5 22.70 Recordkeeping 42 CFR 84.43).......... 56 .......... 56.75 Disclosure-Labeling 42 CFR 84.33..... 56 10.5 1.54 42 CFR 84.257........................ 56 10.5 1.50 42 CFR 84.1103....................... 56 10.5 1.50 Estimated Total Annual Burden--133,474 hours ------------------------------------------------------------------------ 5. HRSA Noncompeting Training Grant Application, Supplements and Related Regulations--0915-0061--Revision--The Health Resources and Services Administration uses this information to determine the eligibility of grantees to continue their previously approved grant project. The review includes calculation of the amount of each award and the evaluation of progress made. Three new user programs are being added and some changes are being made to program supplemental instructions. Respondents: Not-for-profit institutions; Number of Respondents: 938; Number of Responses per Respondent: 1; Average Burden per Response: 25.5 hrs.; Estimated Total Annual Burden: 23,919 hours. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. 6. National Surveillance of Dialysis--Associated Diseases--0920- 0033--Revision--This annual survey of hemodialysis facilities is conducted to determine the incidence and trend of hemodialysis- associated diseases so that appropriate control measures can be devised. Respondents: Business of other for-profit; Number of Respondents: 2,340; Number of Responses per Respondent: 1; Average Burden per Response: .58 hr.; Estimated Total Annual Burden: 1,365 hours. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. 7. Good Laboratory Practices (GLP) Regulations for NonClinical Studies--21 CFR Part 58 0910-0119--Extension, no change--The GLP regulations are used to assure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products. The required information will help assure that only safe products are approved for marketing. Respondents: Business or other for-profit; Not- for-profit institutions; Federal Government. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. ------------------------------------------------------------------------ Average No. of No. of burden/ respondents responses/ response respondent (hrs) ------------------------------------------------------------------------ Reporting--21 CFR 58.35(b)(7)........ 400 60.2 1 Reporting--21 CFR 58.105(a)(b)....... 400 5.0 11.8 Reporting--21 CFR 58.113(a).......... 400 15.4 6.8 [[Page 34287]] Reporting--21 CFR 58.185............. 400 60.2 27.65 Recordkeeping--21 CFR 58.29(b)....... 400 20 4.25 Recordkeeping--21 CFR 58.35(b)(1)(2)(3)(c)................ 400 271 3.36 Recordkeeping--21 CFR 58.63(b)(c).... 400 250 5.5 Recordkeeping--21 CFR 58.51(a)(b)(c). 400 300 .14 Recordkeeping--CFR 58.90(c)(g)....... 400 5.7 .8 Recordkeeping--21 CFR 58.107(d)...... 400 1 4.25 Recordkeeping--21 CFR 58.120......... 400 15.4 32.7 Recordkeeping--21 CFR 58.195......... 400 250 3.9 Estimated Total Annual Burden--1,739,000 hours ------------------------------------------------------------------------ 8. Women's Health and Aging Study--0925-0376--Extension--This prospective epidemiologic study examines and follows, for a period of 3 years, 1,000 disabled elderly women living within a defined geographic area in Baltimore City and County. The overall goal of this study is to understand the causes and course of physical disability in women age 65 years and older. Respondents: Individual or households; Number of Respondents: 1,097; Number of Responses per Respondent: 2; Average Burden per Response: 1 hr; Estimated Total Annual Burden: 2,194 hours. Send comments to James Scanlon, Office of the Assistant Secretary for Health, Room 737-F, Humphrey Building, 200 Independence Ave., S.W., Washington, D.C. 20201. 9. Gonococcal Isolate Surveillance Project--0920--0307--Extension, no change--Gonococcal Isolate Surveillance Project (GISP) is a national sentinel surveillance system that monitors the trends in antimicrobial susceptibilities guidelines for the treatment of gonorrhea infections. The respondents are five regional laboratories and 25 sexually transmitted disease clinics. Respondents: Not-for-profit institutions; State, Local or Tribal Government; Number of Respondents: 33; Number of Responses per Respondent: 527.3; Average Burden per Response: 0.597 hr.; Estimated Total Annual Burden: 10,400 hours. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. 10. Phase I Implementation of the 1996 NHIS Basic Module--New--The National Health Interview Survey (NHIS) is a multi-purpose health survey, and is a principle source of information on the health of the civilian, household population of the United States. The NHIS is being redesigned for 1996, to implement the use of the Computer Assisted Personal Interview (CAPI) data collection system. This request is for approval of the first phase and the overall description. Respondents: Individuals or households; Number of Respondents: 1,500; Number of Responses per Respondent: 1; Average Burden per Response: 1.51 hr.; Estimated Total Annual Burden: 2,258 hours. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. 11. Application Form and Related Forms for the Operation of the National Death Index--Extension, no change--Researchers apply to use the National Death Index (NDI) to determine whether persons in their studies have died and to obtain the states of death and death certificate numbers of the decedents. The five administrative forms are completed by researchers in order to apply for NDI services and to submit records of study subjects for computer matching against the NDI file. Respondents: Not-for-profit institutions; Number of Respondents: 120; Number of Responses per Respondent: 6.5; Average Burden per Response: .291 hr., Estimated Total Annual Burden: 227 hours. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. 12. Healthy Schools, Healthy Communities Program National Evaluation: Master Survey Instrument--New--As part of the national evaluation of the Healthy Schools, Healthy Communities Program, surveys will be conducted of elementary, middle, and high school students in grantee schools and comparison schools, and parents of surveyed elementary school students. Data on health services utilization, health problems, and risk behaviors will be collected. Respondents: Individuals or households. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ Average No. of No. of burden/ respondents responses/ response respondent (hrs) ------------------------------------------------------------------------ Survey of Students................... 10,900 2 .69 Survey of Parents.................... 4,300 2 .29 Estimated Total Annual Burden--17,620 hours ------------------------------------------------------------------------ 13. Mammography Facilities--Requirements for Accrediting Bodies and Quality Standards and Certification Requirements--21 CFR Part 900-- New--These Interim Rules implement the accreditation, quality standards, and certification provisions of the Mammography Quality Standards Act of 1992. The intent of these interim rules is to assure safe, reliable, and accurate mammography on a nationwide level. Respondents: Business or other-for-profit. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ Average No. of No. of burden/ respondents responses/ response respondent (hrs) ------------------------------------------------------------------------ 21 CFR 900--Reporting................ 12,887 1 17.73 21 CFR 900--Recordkeeping............ 50,000 1 1 Estimated Total Annual Burden--82,810 hours ------------------------------------------------------------------------ 14. Women's Health Initiative: Modifications for An Investigation of Oral Hard Tissue Status in Relation to Skeletal Bone Mineral Density Measures and Osteoporosis--0925-0414--Revision--This study will evaluate the results of a study of tooth and oral bone status for a sample of 1,000 women [[Page 34288]] enrolled in the Observational Component of the Women's Health Initiative at a Bone Density Center and correlate these measures with skeletal bone density assessments. Results will provide critical information for addressing the oral health problems confronting peri- and post-menopausal women. Respondents: Individuals or households; Business or other for-profit. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ Currently approved.............. 51,250 1.66 1.114 Oral Hard Tissue Modification: Cohort Women................... 1,000 1 47 Their Dentists.................. 150 .......... .084 Estimated Total Annual Burden--94,916 hours ------------------------------------------------------------------------ 15. Community Partnership Demonstration Program Surveys: Student Survey and Adult Community 0930-0161--Revision--The Youth and Adult surveys collect alcohol and drug abuse data from communities that participate in the Community Partnership Demonstration Program (CPDP) as well as control communities, to provide estimates of the efficiency of the CPDP. Findings will be used by the Center for Substance Abuse Prevention and Congress to maximize the efficiency of future prevention programs. Respondents: Individuals or households. Send comments to James Scanlon, Office of the Assistant Secretary for Health, Room 737- F, Humphrey Building, 200 Independence Ave., S.W., Washington, D.C. 20201. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ Student Survey.................. 23,057 1 0.7 Adult Community Survey.......... 8,644 1 0.7 Estimated Total Annual Burden--22,190 hours ------------------------------------------------------------------------ 16. Joint FDA/NHLBI Health and Diet Survey, Cycle VI--New--A population sample of consumers will be interviewed about knowledge, awareness and practices with respect to ongoing health promotional initiatives in order to evaluate the impact of these initiatives and discern continuing educational needs. Respondents; Individuals or households. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ Screener........................ 4,400 1 .017 Main Survey..................... 4,000 1 .45 Estimated Total Annual Burden--1,875 hours ------------------------------------------------------------------------ 17. Human Tissue Intended for Transplantation, 21 CFR 1270--0910- 0302--Revision--This rule requires certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantations. Respondents: Business or other for-profit; Not-for-profit institutions. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ No. of Average No. of responses/ burden/ respondents respondent response(hrs) ------------------------------------------------------------------------ Recordkeeping: 21 CFR 1270.7(b). 400 1 48 21 CFR 1270.9(a) & .11(a)....... 400 1 3.75 21 CFR 1270.11(b)............... 400 1 3.50 Estimated Total Annual Burden--22,100 hours ------------------------------------------------------------------------ 18. Pretest of Round 2 and HIPS for the Household Components (FAMES) of the National Medical Expenditures Survey (NMES-3)--New--This includes a pretest of Round 2 of a household survey and a pretest of a survey of employers and health insurance providers identified in the Round 1 pretest household interviews. No interviews will be administered in the Round 2 pretest. The purpose of the round is to collect signed permission forms from persons in sample households. These forms are needed to field the survey of employer and health insurance providers (HIPS). HIPS will verify and supplement health insurance coverage details reported by household respondents. Respondents: Individuals or housholds; Business or other for-profit. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, D.C. 20503. ------------------------------------------------------------------------ Average No. of No. of burden/ respondents responses/ response respondent (hrs) ------------------------------------------------------------------------ Round 2 Pretest for NMES-3 Household Component........................... 218 1 .509 HIPS Pretest......................... 307 1 .495 Estimated Total Annual Burden--263 hours. ------------------------------------------------------------------------ 19. Requirement for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States--0920-0263--Extension, no change--Under a special permit arrangement importers must submit a plan to CDC for the importation/quarantine of specific monkeys covered. Information requested is necessary to make public health decisions, evaluate compliance with the standards, and determine the adequacy of measures taken to prevent exposure of persons and animals during importation. Respondents: Business or other for-profit; Not-for-profit institutions; Number of Respondents: 20; Number of Responses per Respondent: 5; Average Burden per Response: 0.14 hr.; Estimated Total Annual Burden: 14 hours. Send comments to James Scanlon, Office of the Assistant Secretary for Health, Room 737-F, Humphrey Building, 200 Independence Ave., S.W., Washington, D.C. 20201. 20. Pilot Test of Revisions to the National Health Service Corps Scholarship Program--New--A Pilot Study is proposed of a consolidated application and interview process for the National Health Service Corps (NHSC) Scholarship Program. The revised application process is designed to improve the Agency's ability to identify applicants likely to remain in primary care after they have completed their service obligation. Respondents: Individuals or housholds; Number of Respondents: 300; Number of Responses per Respondent: 1; Average Burden per Response: 3.2 hrs.; Estimated Total Annual Burden: 963 hours. Send comments to Shannah Koss, Human Resources and Housing Branch, New Executive office Building, Room 10235, Washington, D.C. 20503. Written comments and recommendations concerning the proposed information collections should be sent within 30 days of this notice directly to the individual designated. [[Page 34289]] Dated: June 27, 1994. James Scanlon, Director, Data Policy Staff, Office of the Assistant Secretary for Health and PHS Reports Clearance Officer. [FR Doc. 95-16198 Filed 6-29-95; 8:45 am] BILLING CODE 4160-01-M --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-16198. Public record. Not legal advice.