32674 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revised guidance for

industry and reviewers entitled ‘‘Repeal

of Section 507 of the Federal Food,

Drug, and Cosmetic Act.’’ The guidance

clarifies the processes that will be

followed in implementing this section

of the Food and Drug Administration

Modernization Act of 1997

(Modernization Act). This revision

includes clarification of the procedures

applicable to bulk drug substances for

products previously regulated under the

Federal Food, Drug, and Cosmetic Act

(the act).

DATES: General comments on the agency

guidance documents are welcome at any

time.

ADDRESSES: Copies of this guidance are

available on the Internet at http://

www.fda.gov/cder/guidance/index.htm.

Submit written requests for single

copies of this guidance to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

For general information regarding this

notice: Murray M. Lumpkin, Center

for Drug Evaluation and Research

(HFD–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

5400.

For issues on bulk drug substance

procedures: Gordon R. Johnston,

Center for Drug Evaluation and

Research (HFD–601), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

827–5845.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a revised

guidance for industry and reviewers

entitled ‘‘Repeal of Section 507 of the

Federal Food, Drug, and Cosmetic Act.’’

Section 125 of title I of the

Modernization Act (Pub. L. 105–115),

signed into law by President Clinton on

November 21, 1997, repealed section

507 of the act (21 U.S.C. 357). As a

result of the repeal of section 507 of the

act, which took effect immediately,

several of the agency’s administrative

processes for reviewing and approving

antibiotic drug applications had to be

changed. This guidance document,

intended to clarify several of the

administrative processes that will be

followed in implementing section 125 of

the Modernization Act, has now been

revised to include the procedures

applicable to bulk drug substances for

products previously marketed under

section 507 of the act.

This revised guidance document is a

level 1 guidance document consistent

with FDA’s good guidance practices (62

FR 8961, February 27, 1997). It

represents the agency’s current thinking

on the implementation of the repeal of

section 507 of the act. It does not create

or confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both.

Interested persons may, at any time,

submit comments on the guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: June 8, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–15769 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) will publish periodic

summaries of proposed projects being

developed for submission to OMB under

the Paperwork Reduction Act of 1995.

To request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Disadvantaged

Assistance Tracking and Outcome

Report (New)

The Health Careers Opportunity

Program (HCOP) and the Centers of

Excellence (COE) Program (sections 740

and 739 of the Public Health Service

(PHS) Act, respectively) provide

opportunities for under-represented

minorities and disadvantaged

individuals to enter and graduate from

health professions schools. The

Disadvantaged Assistance Tracking and

Outcome Report (DATOR) will be used

to track program participants through

the health professions pathway to a

health professions practice outcome.

The current inability to track students’

education progression in the health

professions is a major impediment in

assessing the outcome of these

programs. There is no identifier used

that transcends the various education

levels, professional disciplines, and

educational institutions.

The DATOR, to be completed

annually by HCOP and COE grantees,

includes basic data on student

participants (name, social security

number, gender, race/ethnicity; targeted

health professions, their status in the

educational pipeline from preprofessional through professional

training; financial assistance received

through the grants funded under

sections 739 and 740 of the PHS Act in

the form of stipends, fellowships or per

diem; and their employment or practice

setting following their entry into the

health care work force).

The proposed reporting instrument is

not expected to add significantly to the

grantees reporting burden. This

reporting instrument complements the

grantees internal automated reporting

mechanisms of using name and social

security number in tracking students.

Estimates of annualized burden are as

follows:
Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32675

Type of report Number of respondents

Responses

per respondent

Hours per responseTotal burden

hours

Disadvantaged Assistance Tracking Outcome Report (DATOR) .................... 200 1 10 2,000

Send comments to the HRSA Reports

Clearance Officer, Room 14–36,

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857; telephone number

(301) 443–1129. Written comments

should be received within 60 days of

this Notice.

Dated: June 5, 1998.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 98–15764 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Correction of Meeting Notice

Pursuant to Pub. L. 92–463, notice is

hereby given of a correction of a notice

of meeting of the SAMHSA Special

Emphasis Panel II meeting to be held in

July 1998.

Public notice was given in the Federal

Register on June 9, 1998 (Volume 63,

Number 110, page 31517) that the SEP

II would be meeting on July 1, 1998, at

the Parklawn Building, Room 16C–26.

The date of this meeting ha

subsequently changed to June 29, 1998.

The agenda of the meeting and the

contact for additional information

remain as announced.

Dated: June 9, 1998.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 98–15811 Filed 6–12–98; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4351–N–06]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Policy Development and

Research, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments are due on or before

August 14, 1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and should be

sent to: Reports Liaison Officer, Office

of Policy Development and Research,

Department of Housing and Urban

Development, 451 7th Street, SW.,

Room 8226, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Alan Fox, Economic and Market

Analysis Division, Office of Policy

Development and Research, Department

of Housing and Urban Development,

451 7th Street, SW., Room 8222,

Washington, DC 20410; telephone (202)

708–0614, Extension 5863; e-mail

alanlfox@hud.gov. This is not a tollfree number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Mr. Fox.

SUPPLEMENTARY INFORMATION: The

Department of Housing and Urban

Development will submit the proposed

information collection package to OMB

for review as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended.)

This Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(2) Evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information; (3) Enhance

the quality, utility, and clarity of the

information to be collected; and (4)

Minimize the burden of the collection of

information on those who are to

respond; including the use of

appropriate automated collection

techniques or other forms of information

technology, e.g., permitting electronic

submission of responses.

This Notice also lists the following

information:

Title of Proposal: Section 8 Random

Digit Dialing Fair Market Rent

Telephone Survey.

OMB Control Number: 2528–0142.

Description of the need for the

information and proposed use: This

provides HUD with a fast, inexpensive

way to estimate and update Section 8

Fair Market Rents (FMRs) in areas not

covered by AHS or CPI surveys, and in

areas where FMRs are believed to be

incorrect. It also provides estimates of

annual rent changes. Section 8(C)(1) of

the United States Housing Act of 1937

requires the Secretary to publish Fair

Market Rents (FMRs) annually to be

effective on October 1 of each year.

FMRs are used for the Section 8 Rental

Certificate Program (including space

rentals by owners of manufactured

homes under that program); the

Moderate Rehabilitation Single Room

Occupancy program; housing assisted

under the Loan Management and

Property Disposition programs; payment

standards for the Rental Voucher

program; and any other programs whose

regulations specify their use.

Random digit dialing (RDD) telephone

surveys have been used for several years

to adjust FMRs. These surveys are based

on a sampling procedure that uses

computers to select statistically random

samples of telephone numbers to locate

certain types of rental housing units for

surveying. HUD contracts with a private

company to conduct two types of RDD

surveys: (1) Approximately 50

individual FMR areas are surveyed

every year to test the accuracy of their

FMRs; (2) In addition, 20 RDD surveys

are conducted every year to provide

updating factors for FMRs not surveyed

individually and for Annual Adjustment

Factors (AAFs). These surveys are

conducted in the nonmetropolitan

portions of all 10 HUD regions, and in

the 10 metropolitan portions that do not

have their own Consumer Price Index

(CPI) surveys.

Members of affected public:

Individuals or households living in

areas surveyed.

Estimation of the total numbers of

hours needed to prepare the information

collection including number of

respondents, frequency of response, and

hours of response: The RDD surveys

require a great many telephone calls to

reach the required number of eligible

respondents—those living in 1 or 2

bedroom nonsubsidized rental housing,