Agency Forms Undergoing Paperwork Reduction Act Review

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