[Federal Register Volume 59, Number 130 (Friday, July 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16486]
[[Page Unknown]]
[Federal Register: July 8, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Agency Forms Submitted to the Office of Management and Budget for
Clearance
Each Friday the Public Health Service (PHS) publishes a list of
information collection requests it has submitted to the Office of
Management and Budget (OMB) for clearance in compliance with the
Paperwork Reduction Act (44 U.S.C. chapter 35). The following requests
have been submitted to OMB since the list was last published on Friday,
June 24, 1994.
(Call PHS Reports Clearance Officer on 202-690-7100 for copies of
request).
1. Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution--0910-0045 (Revision)--This revision
incorporates the Food and Drug Administration's new regulation,
``Imprinting of Solid Oral Dosage Form Drug Products for Human Use--
Final Rule.'' Information must be provided to insure agency regulatory
action and surveillance of drug products. Information is also used to
publish the NDC Directory which is used by the drug industry, third
party reimbursement firms, insurance companies, and other government
regulatory agencies.
Respondents: Businesses or other for-profit; Small Businesses or
organizations.
------------------------------------------------------------------------
Number of
Number of responses Average
Title respondents per burden per
respondent response
------------------------------------------------------------------------
21 CFR, 207.25(c) Imprint-- 1,500 12.04 .05 hour.
Reporting.
Currently Approved Reporting.... 14,500 2.31 .50 hour.
Currently Approved Recordkeeping 14,500 N/A .039 hour.
------------------------------------------------------------------------
Estimated Total Annual Burden: 31,367 hours.
2. Portable Self-Recording Flow-Meter in the Investigation of
Occupational Airways Disorders--0920-0279 (Revision)--This submission
is for extension of current approval for the National Institute of
Occupational Safety and Health to test a newly developed portable self-
recording flow meter which may offer important advantages in the
investigation of occupational asthma and acutely toxic or irritating
environments. The new device offers investigators the potential for
reducing the requirements for recording results while obtaining
multiple, accurate and valid lung function measures before, during and
after the workshift.
Respondents: Individuals or households.
------------------------------------------------------------------------
Number of
Number of responses Average
Title respondents per burden per
respondent response
------------------------------------------------------------------------
Phase 1-5....................... 230 2 1.84 hours.
Screener........................ 275 1 .10 hour.
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Estimated Total Annual Burden: 873 hours.
3. Health Education Assistance Loan (HEAL) Program Regulations--42
CFR Part 60--0915-0108 (Revision)--These notification, reporting and
recordkeeping requirements insure that the lenders, holders and schools
participating in the HEAL program follow sound management procedures in
the administration of federally-insured student loans.
Respondents: Individuals or households; Businesses or other for-
profit; Non-profit institutions.
------------------------------------------------------------------------
Number of
Number of responses Average
Title respondents per burden per
respondent response
------------------------------------------------------------------------
Reporting....................... 351 1.9 2.5 hours.
Notification.................... 31,255 13.8 .25 hour.
Recordkeeping................... 351 1,114 .19 hour.
------------------------------------------------------------------------
Estimated Total Annual Burden: 183,544 hour.
4. Evaluation of the Ryan White Title IV HIV Demonstration Program
for Children, Adolescents, and Families--New--Information needed to
evaluate the Ryan White Title IV HIV Demonstration Program for
Children, Adolescents, and Families will be collected from project
staff and clients. Multiple data collection mechanisms will be used,
including self-administered questionnaires (all 36 grantees), site
visits to 18 grantees, and focus groups with clients at ten grantee
sites.
Respondents: Individuals or households; Non-profit institutions;
Small businesses or organizations.
------------------------------------------------------------------------
Number of
Number of responses Average
Title respondents per burden per
respondent response
------------------------------------------------------------------------
Self-Study Guide................ 36 1 4 hours.
Site Visits..................... 180 1 3 hours.
Focus Groups.................... 120 1 3 hours.
------------------------------------------------------------------------
Estimated Total Annual Burden: 1,044 hours.
5. Deferment Request Form for the National Health Service Corps and
Native Hawaiian Health Scholarship Programs--New--Scholars
participating in the National Health Service Corps or Native Hawaiian
Health Scholarship Programs who wish to defer their service obligation
in order to complete advanced training must submit information on the
training program to the Secretary. This is a request for approval of
the deferment form and associated requirements.
Respondents: Individuals or households.
------------------------------------------------------------------------
Number of
Number of responses Average
Title respondents per burden per
respondent response
------------------------------------------------------------------------
Deferment Request Form.......... 200 1 .5 hour.
Associated Notification 30 1 1 hour.
Requirements.
------------------------------------------------------------------------
Estimated Total Annual Burden: 130 hours.
6. Evaluation of Learning Needs in AETC Service Areas--New--AIDS
Education and Training Centers (AETCs) are required, as a condition of
award, to conduct an assessment of training needs in their service
areas every three years. A standardized protocol has been developed for
identifying training needs of physicians, physician assistants, nurses,
certified nurse practitioners, dentists, and dental hygienists.
Respondents: Individuals or households; Number of Respondents: 13,561;
Number of Responses per Respondent: 1; Average Burden per Response: .19
hour; Estimated Annual Burden: 2,557 hours.
7. Responsibility of Applicants for Promoting Objectivity in
Research for Which PHS Funding is Sought: 42 CFR Part 50 and 48 CFR
Part 309--NPRM--New--The purpose of this rule is to protect the
objectivity with which PHS-funded research is conducted. Disclosure of
financial interests related to PHS-funded research by personnel who
have decision making responsibilities that could affect the outcome of
the research is required. The NPRM appeared in the Federal Register on
June 28, 1994 (Vol. 59, No. 123, pp. 33242-33251). Respondents:
Individuals or households; State or local governments; Businesses or
other for-profit; Non-profit institutions; Small businesses or
organizations; Estimated Annual Burden: 1 hour.
Written comments and recommendations concerning the proposed
information collections should be sent within 30 days of this notice
directly to the OMB Desk Officer designated below at the following
address: Shannah Koss, Human Resources and Housing Branch, New
Executive Office Building, room 10235, Washington, DC 20503.
Dated: June 30, 1994.
James Scanlon,
Director, Division of Data Policy, Office of Health Planning and
Evaluation.
[FR Doc. 94-16486 Filed 7-7-94; 8:45 am]
BILLING CODE 4160-17-M
