Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices 32625

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

370 L’Enfant Promenade, SW.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments 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)

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.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: June 6, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–15123 Filed 6–14–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0249]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Consumer and

Producer Surveys on Economic Issues

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

proposed voluntary surveys of

consumers and producers in order to

help FDA comply with Executive Order

12866, the Regulatory Flexibility Act

(RFA), and the Small Business

Regulatory Enforcement Fairness Act of

1996 (SBREFA).

DATES: Submit written or electronic

comments on the collection of

information by August 14, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1227.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR 1320.3

and includes agency requests or

requirements that members of the public

submit reports, keep records, or provide

information to a third party. Section

3506(c)(2)(A) of the PRA (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies

to provide a 60-day notice in the

Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Consumer and Producer Surveys on

Economic Issues

Under section 903(d)(2) of the Federal

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

393(d)(2)), FDA is authorized to conduct

research relating to regulated articles

and to collect information relating to

responsibilities of the agency. Executive

Order 12866, RFA, and SBREFA direct

Federal agencies to conduct regulatory

impact analysis, and to consider flexible

regulatory approaches. In order to

perform the mandatory analysis it is

often necessary to survey: (1) Regulated

producers to determine existing

practices and the changes in those

practices likely under various policy

options, (2) both consumers and

manufacturers to explore attitudes

towards policy proposals, and (3)

industry experts to solicit expert

opinions. FDA is seeking OMB

clearance to conduct future surveys to

implement Executive Order 12866, RFA,

and SBREFA. Participation in the

surveys will be voluntary. This request

covers regulated entities, such as food

processors, dietary supplement

manufacturers, health professionals or

other experts, and consumers.

FDA will use the information

gathered from these surveys to identify

current business practices, expert

opinion, and consumer or manufacturer

attitudes towards existing or proposed

policy. FDA projects approximately 2 to

6 surveys per year, with a sample of

between 10 and 1,000 respondents each

for mail and telephone surveys, and a

sample of up to 3,000 respondents for

cable or internet surveys.

FDA estimates the upper bound

burden of this collection of information

as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Type of Survey No. of Respondents Annual Frequency

per Response Hours per Response Total Hours

Mail questionnaire ................................................... 1,000 1 3 3,000

32626 Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Type of Survey No. of Respondents Annual Frequency

per Response Hours per Response Total Hours

Phone survey .......................................................... 1,000 1 0.5 500

Internet or cable survey .......................................... 3,000 1 1 3,000

Total ........................................................................ 6,500

1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on the

expected number of respondents

necessary to obtain a statistically

significant stratification of the average

to large size industries—including small

business entities covered by FDA

regulations—and consumers of

regulated products.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15082 Filed 6–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0135]

Agency Information Collection

Activities; Announcement of OMB

Approval; Focus Group Study of

Radiation Disclosure Statement

Options for Foods Treated With

Ionizing Radiation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Focus Group Study of Radiation

Disclosure Statement Options for Foods

Treated with Ionizing Radiation’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 29, 2001 (66

FR 17183), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0468. The

approval expires on October 31, 2001. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15084 Filed 6–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1682]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Radioactive Drug Research Committee

Report on Research Use of

Radioactive Drugs Membership

Summary and Study Summary

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (PRA).

DATES: Submit written comments on the

collection of information by July 16,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Radioactive Drug Research Committee

Report on Research Use of Radioactive

Drugs Membership Summary and Study

Summary (OMB Control No. 0910–

0053)—Extension

Under sections 201, 505, and 701 of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 355, and 371), FDA

has the authority to issue regulations

governing the use of radioactive drugs

for certain research uses. The

regulations in § 361.1 (21 CFR 361.1)

establish the conditions under which

radioactive drugs are generally

recognized as safe and effective for

certain research purposes.

The regulations in § 361.1 set forth

specific requirements for the

establishment and composition of

Radioactive Drug Research Committees

(RDRCs) and their role in approving and

monitoring the use of radioactive drugs

in certain types of research. These

radioactive drugs may not be given to

human subjects without the

authorization of an FDA-approved

RDRC (§ 361.1(d)(7)). The types of

studies authorized under § 361.1 are

those intended to obtain basic

information on the metabolism of a

radioactively labeled drug or regarding

human physiology, pathophysiology, or

biochemistry. Research intended for

immediate therapeutic, diagnostic, or

similar purposes or to determine the

safety and effectiveness of a radioactive

drug in humans (i.e., to carry out a

clinical trial) may not be conducted

under an RDRC. Research for such

purposes requires the submission of an

investigational new drug application

under 21 CFR part 312.

Section 361.1 requires the RDRCs to

perform various activities involving the

collection of information and reporting

to FDA that are subject to the PRA.

Under § 361.1(c)(2), each RDRC must do

the following: (1) Select a chairman who

must sign all applications, minutes, and

reports of the committee; (2) meet at