12802 Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Notices

reuse or remanufacture devices are now

considered manufacturers under new

FDA guidance. It is estimated that out

of the 6,000 hospitals in the United

States, one-third of them (or 2,000

hospitals) will reuse or remanufacture

single use medical devices. Thus, the

number of manufacturers will increase

from 5,463 to 7,463 making the total

number of firms subject to CGMP’s

9,229.

• Potentially affected establishments:

Except for manufacturers, not every type

of firm is subject to every CGMP/QS

requirement. For example, all are

subject to quality policy (§ 820.20(a)),

document control (§ 820.40), and other

requirements, whereas only

manufacturers and specification

developers are subject to part 820

Subpart C—Design Controls. The type of

firm subject to each requirement was

identified by ERG.

FDA estimated the burden hours (and

costs) for the previous CGMP regulation

in 1992. That estimate was submitted to

OMB on May 4, 1992, under OMB

Paperwork Reduction Act submission

No. 0910–0073. It was approved by

OMB on July 16, 1992, and it expired on

June 30, 1995. The methodology used is

different than that used by ERG in

estimating incremental tasks when the

new CGMP/QS became a final rule.

Nevertheless, the agency believes its

1992 estimate adequately represents

labor hours (and costs) needed to

comply with previous CGMP

requirements carried over into the new

CGMP/QS regulation. The 1992 estimate

used 9,289 respondents (rather than

9,229 respondents), which compensates

for differences in methodology.

FDA estimates that some 650 ‘‘new’’

establishments (marketing devices for

the first time) will expend some 114,882

‘‘development’’ hours on a one-time

startup basis to develop records and

procedures for the CGMP/QS regulation.

FDA estimates that annual labor hours

are apportioned as follows: 40 percent—

to requirements dealing with

manufacturing specifications, process

controls and the DHR; 20 percent—to

requirements dealing with components

and acceptance activities; 25 percent—

to requirements dealing with

equipment, records (the DMR and QSR),

complaint investigations, labeling/

packaging and reprocessing/

investigating product nonconformance;

and 15 percent—to quality audit,

traceability, handling, distribution,

statistical, and other requirements.

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4850 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0069 ]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Information From

U.S. Processors That Export to the

European Community

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

the maintenance of lists of U.S.

processors that export certain animalderived foods (i.e., shell eggs, dairy

products, game meat, game meat

products, animal casings, and gelatin) to

the European Community (EC),

temporary exemptions from certain food

labeling requirements for the purpose of

conducting authorized food labeling

experiments, petitions for health claims,

and petitions for nutrient content

claims.

DATES: Submit written or electronic

comments on the collection of

information by April 30, 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,

301–827–1223.

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.

Request for Information From U.S.

Processors That Export to the European

Community (OMB Control Number

0910–0320)—Extension

EC is a group of 15 European

countries that have agreed to harmonize

their commodity requirements to

facilitate commerce among member

States. EC legislation for intra-EC trade

has been extended to trade with non-EC

countries, including the United States.

For certain food products, including

those listed below in this document, EC

legislation requires assurances from the

responsible authority of the country of

origin that the processor of the food is

in compliance with applicable

regulatory requirements.

With the assistance of trade

associations and State authorities, FDA

requests information from processors

Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Notices 12803

that export certain animal-derived

products (e.g., shell eggs, dairy

products, game meat, game meat

products, animal casings, and gelatin) to

EC. FDA uses the information to

maintain lists of processors that have

demonstrated current compliance with

U.S. requirements and provides the lists

to EC quarterly. Inclusion on the list is

voluntary. EC member countries refer to

the lists at ports of entry to verify that

products offered for importation to EC

from the United States are from

processors that meet U.S. regulatory

requirements. Products processed by

firms not on the list are subject to

detention and possible refusal at the

port. FDA requests the following

information from each processor:

1. Business name and address;

2. Name and telephone number of

person designated as business contact;

3. Lists of products presently being

shipped to EC and those intended to be

shipped in the next 6 months;

4. Name and address of

manufacturing plants for each product;

5. Names and affiliations of any

Federal, State, or local governmental

agencies that inspect the plant,

government-assigned plant identifier,

such as plant number, and last date of

inspection; and

6. Assurance that the firm or

individual representing the firm and

submitting a certificate for signature to

FDA is aware of and knows that they are

subject to the provisions of section 1001

of Title 18, United States Code. This law

provides that it is a criminal offense to

knowingly and willfully make a false

statement or alter or counterfeit

documents in a matter within the

jurisdiction of a U.S. agency.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Products No. of

respondents

Annual

frequency per

response

Total annual responsesHours per

response Total hours

Shell eggs 10 1 10 0.25 2.5

Dairy 100 1 100 0.25 25

Game meat and meat products 10 1 10 0.25 2.5

Animal casings 15 1 15 0.25 3.75

Gelatin 6 1 6 0.25 1.5

Total 35.25

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

The estimated number of respondents

is based on the volume of exports and

responses received to date. The

estimated number of yearly responses

has decreased from the estimate in

FDA’s previous notice seeking comment

for this collection of information (63 FR

29738, June 1, 1998) because the actual

number of responses has been

decreasing. Companies do not need to

reapply unless they have a compliance

problem. An estimate for processors that

export gelatin also has been added

because these processors are now being

included in the listing process.

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN (THIRD PARTY DISCLOSURE)1

Respondents No. of

respondents

Annual

frequency per

response

Total annual responsesHours per

response Total hours

Trade association 15 1 15 8 120

State 50 1 50 8 400

Total 520

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

The burden estimated for the trade

associations assumes the trade

associations will disseminate FDA’s

information request through mass

mailings to their membership or publish

it in their trade magazine or newsletter.

The burden estimated for State

authorities assumes dissemination of

information to the processors or

dissemination of information about

processors to FDA.

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4851 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1440]

Agency Information Collection

Activities; Announcement of OMB

Approval; User Fee Cover Sheet

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘User Fee Cover Sheet’’ 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 5, 2000

(65 FR 75942), 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 0910–0297. The

approval expires on February 29, 2004.