66636 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 94D–0422 and 93N–0005]

Revocation of Certain Guidance

Documents on Positron Emission

Tomography Drug Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is revoking two

notices regarding guidance documents

affecting positron emission tomography

(PET) radiopharmaceutical drug

products. The guidance documents

address FDA’s regulatory approach to

PET drug products and current good

manufacturing practice (CGMP)

requirements for such products. FDA is

revoking these notices along with the

guidance documents to which the

notices relate in accordance with

provisions of the Food and Drug

Administration Modernization Act of

1997 (the Modernization Act).

Elsewhere in this issue of the Federal

Register, FDA is announcing the

revocation of a final rule.

EFFECTIVE DATE: December 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Brian L. Pendleton, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5649.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, President Clinton

signed into law the Modernization Act

(Pub. L. 105–115). Section 121(c)(1)(A)

of the Modernization Act directs FDA to

develop appropriate procedures for the

approval of PET drugs as well as CGMP

requirements for such drugs, taking into

account any relevant differences

between not-for-profit institutions that

compound PET drugs and commercial

manufacturers. FDA is to establish these

procedures and requirements not later

than 2 years after the date of enactment.

In doing so, the agency must consult

with patient advocacy groups,

professional associations,

manufacturers, and persons licensed to

make or use PET drugs.

Under section 121(c)(2) of the

Modernization Act, FDA cannot require

the submission of new drug applications

(NDA’s) or abbreviated new drug

applications (ANDA’s) for compounded

PET drugs that are not adulterated

under section 501(a)(2)(C) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

351(a)(2)(C)) for a period of 4 years after

the date of enactment, or 2 years after

the date that the agency adopts special

approval procedures and CGMP

requirements for PET drugs, whichever

is longer.

Section 121(d) of the Modernization

Act requires FDA, within 30 days of

enactment, to terminate the application

of two notices that were published in

the Federal Register on February 27,

1995 (60 FR 10593 and 10594). One

notice is entitled ‘‘Regulation of

Positron Emission Tomography

Radiopharmaceutical Drug Products;

Guidance; Public Workshop’’ (60 FR

10594). The notice included a guidance

document entitled ‘‘Regulation of PET

Radiopharmaceuticals.’’ This guidance

document, among other things, stated

that a manufacturer of a PET drug was

required to obtain FDA approval of an

NDA or ANDA in accordance with 21

CFR part 314.

In the other notice, FDA announced

the availability of its ‘‘Draft Guideline

on the Manufacture of Positron

Emission Tomography

Radiopharmaceutical Drug Products’’

(60 FR 10593). In the Federal Register

of April 22, 1997 (62 FR 19580), FDA

published a notice of availability of a

final version of this guidance entitled

‘‘Guidance for Industry: Current Good

Manufacturing Practices for Positron

Emission Tomographic (PET) Drug

Products; Availability.’’ The agency is

hereby revoking these notices as well as

the draft and final guidance documents

on CGMP’s for PET drugs.

Section 121(d) of the Modernization

Act also directs FDA to terminate the

application of a final rule, published in

the Federal Register of April 22, 1997

(62 FR 19493), permitting the agency to

approve requests from manufacturers of

PET drug products for exceptions or

alternatives to provisions of FDA’s

CGMP regulations (21 CFR 211.1(d)).

FDA is announcing the revocation of

this rule in a final rule published

elsewhere in this issue of the Federal

Register.

The notices and corresponding

guidance documents discussed

previously are revoked effective

December 21, 1997.

In accordance with section

121(c)(1)(A) of the Modernization Act,

FDA intends to begin the development

of new PET drug approval procedures

and CGMP requirements immediately

and will obtain appropriate public input

during this process.

Dated: December 16, 1997.

William B. Schultz,

Deputy Commissioner for Policy,

[FR Doc. 97–33188 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–3482–N–04]

Office of Lead Hazard Control; Notice

of Proposed Information Collection:

Comment Request

AGENCY: Office of Lead Hazard Control,

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 due: February 17,

1998.

ADDRESSES: Interesed persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Ms. Ruth Wright, Reports Liaison

Officer, Office of Lead Hazard Control

(L), Department of Housing & Urban

Development, 451—7th Street, SW,

Room B–133, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

David Levitt at (202) 755–1785,

extension 156 (this is not a toll-free

number), Office of Lead Hazard Control,

HUD, for copies of the proposed forms

and other available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

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

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and

affecting 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 through 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:
Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices 66637

Title of Proposal: Requirements for

Disclosure of Lead-Based Paint Hazards

in Residential Housing.

OMB Control Number, if applicable:

2539–0007.

Description of the need for the

information and proposed use: HUD is

requesting approval of a continuation of

current record keeping requirements to

ensure compliance for persons selling,

leasing or acting as agents in

transactions to sell or lease target

housing. This rule was issued on March

6, 1996 under the authority of section

1018 of the Residential Lead-Based

Paint Hazard Reduction Act of 1992.

The records acknowledge that the

sellers, lessors, and agents complied

with the HUD/Environmental Protection

Agency requirements. No changes to the

current requirements are being

requested.

Agency form numbers, if applicable:

None.

Members of affected public:

Individuals or Households, Businesses

or Other For-Profit, Federal Agencies or

Employees, Small Business or

Organizations.

Estimation of the total numbers of

hours needed to prepare the information

collection including number of

respondents, frequency of response, and

hours of response:

Number of

recordkeepers

Annual hours

per recordkeeperBurden hours

Real Estate Transaction Disclosures ............................................................................................. 15,441,000 15.4 min ...... 3,957,210

Total Estimated Burden Hours: 3,957,210.

Status of the proposed information

collection: Continuation.

Authority: Section 3506 of the Paperwork

Reduction Act of 1995, 44 U.S.C. Chapter 35,

as amended.

Dated: December 10, 1997.

David E. Jacobs,

Director, Office of Lead Hazard Control.

[FR Doc. 97–33148 Filed 12–18–97; 8:45 am]

BILLING CODE 4210–32–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–63]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Housing, 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 due: February 17,

1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Oliver Walker, Housing, Department of

Housing & Urban Development, 451—

7th Street, SW., Room 9116,

Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Maurice Gulledge, telephone number

(202) 708–6396 (this is not a toll-free

number) for copies of the proposed

forms and other available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

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

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and

affecting 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

through 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: Survey of Title I

Borrowers.

OMB Control Number: 2502–xxxx.

Description of the need for the

information and proposed use: This

survey is intended to identify significant

program abuses and develop a

comprehensive database of borrower

concerns. Reported instances of program

abuse will be reviewed and followed up

for complaint resolution, or, when

warranted, referred for civil/criminal

litigation.

Form numbers: None.

Members of affected public: Title I

borrowers.

An estimation of the total numbers of

hours needed to prepare the information

collection is .0833,the number of

respondents is 10,000, frequency of

response is on occasion, and the hours

of response is 833.

Status of the proposed information

collection: new collection.

Authority: Section 236 of the Paperwork

Reduction Act of 1995, 44 U.S.C. Chapter 35,

as amended.

Dated: December 15, 1997.

Nicolas P. Retsinas,

Assistant Secretary for Housing—Federal

Housing Commissioner.

[FR Doc. 97–33149 Filed 12–18–97; 8:45 am]

BILLING CODE 4210–27–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4254–N–02]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, 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 due: February 17,

1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Reports Liaison Officer Shelia E. Jones,

Department of Housing and Urban

Development, 451–7th Street, SW,

Room 7230, Washington, DC 20410.