[Federal Register Volume 60, Number 126 (Friday, June 30, 1995)]
[Notices]
[Pages 34285-34289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16198]



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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