Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 21767

submission of routine endorsements as

official recommendations.

Additionally, SPOCs are requested to

clearly differentiate between mere

advisory comments and those official

State process recommendations which

may trigger the accommodation or

explain rule.

When comments are submitted

directly to ACF, they should be

addressed to: William Wilson, Head

Start Bureau, 330 C Street, SW.,

Washington, DC 20447, Attn: Head

Start-Higher Education Hispanic/Latino

Service Partnerships. A list of the Single

Points of Contact (SPOCs) for each State

and Territory can be found on the

following web site: http://

www.whitehouse.gov/omb/grants/

spoc.html.

Dated: April 25, 2001.

Gail E. Collins,

Acting Deputy Commissioner, Administration

on Children, Youth and Families.

[FR Doc. 01–10720 Filed 4–30–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0174]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Recall Regulations

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

FDA’s recall regulations (guidelines)

and provides guidances to

manufacturers on recall responsibilities.

DATES: Submit written or electronic

comments on the collection of

information by July 2, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information via the Internet at 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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

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(c) 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.

FDA Recall Regulations—Part 7

(Subpart C) (21 CFR Part 7 (Subpart

C))—(OMB Control Number 0910–

0249)—Extension

Section 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 371) and 21

CFR part 7, subpart C sets forth the

recall regulations (guidelines) and

provides guidance to manufacturers on

recall responsibilities. The guidelines

apply to all FDA regulated products

(i.e., food, including animal feed; drugs,

including animal drugs; medical

devices, including in vitro diagnostic

products; cosmetics; and biological

products intended for human use).

These responsibilities include

development of a recall strategy that

requires time by the firm to determine

the actions or procedures required to

manage the recall (§ 7.42); providing

FDA with complete details of the recall

including reason(s) for the removal or

correction, risk evaluation, quantity

produced, distribution information,

firm’s recall strategy, copy of any recall

communication(s), and a contact official

(§ 7.46); notifying direct accounts of the

recall, providing guidance regarding

further distribution, giving instructions

as to what to do with the product,

providing recipients with a ready means

of reporting to the recalling firm (§ 7.49);

submitting periodic status reports so

that FDA may assess the progress of the

recall. Status report information may be

determined by, among other things,

evaluating return reply cards,

effectiveness checks and product

returns (§ 7.53); and providing the

opportunity for a firm to request in

writing that FDA terminate the recall

(§ 7.55).

A search of the FDA database was

performed to determine the number of

recalls that took place during fiscal year

2000. The resulting number of recalls

from this database search (1,933) is used

in estimating the current annual

reporting burden for this report. FDA

estimates the total annual industry

burden to collect and provide the above

information to 84,665 burden hours.

The following is a summary of the

estimated annual burden hours for

manufacturers, processors, and

distributors to comply with the

voluntary reporting requirements of

FDA’s recall regulations.

Recognizing that there may be a vast

difference in the information collection

and reporting time involved in different

recalls of FDA’s regulated products,

FDA estimates on average the burden of

collection for recall information as

follows:

21768 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

7.42 1,933 1 1,933 1.8 3,479

7.46 and 7.49 1,933 1 1,933 4.0 7,732

7.53 1,933 1 1,933 36.0 69,588

7.55(b) 1,933 1 1,933 2.0 3,866

Total 84,665

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

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10707 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1489]

Agency Information Collection

Activities; Announcement of OMB

Approval; Sterility Requirements for

Aqueous-Based Drug Products for

Oral Inhalation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information

entitled‘‘Sterility Requirements for

Aqueous-Based Drug Products for Oral

Inhalation’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

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 the

Federal Register of September 18, 2000

(65 FR 56314), 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 0910–0353. The

approval expires on March 31, 2004. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10708 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0511]

Agency Information Collection

Activities; Announcement of OMB

Approval; Hazard Analysis and Critical

Control Point (HACCP); Procedures for

the Safe and Sanitary Processing and

Importing of Juice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Hazard Analysis and Critical Control

Point (HACCP); Procedures for the Safe

and Sanitary Processing and Importing

of Juice’’ 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 January 19, 2001 (66

FR 6138 at 6194), 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 0910–0466. The

approval expires on March 31, 2004. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10709 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1502]

Agency Information Collection

Activities; Announcement of OMB

Approval; Adverse Experience

Reporting for Licensed Biological

Products and General Records

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Adverse Experience Reporting for

Licensed Biological Products and

General Records’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 26, 2000

(65 FR 81528), 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,