41472 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

National Institute for Occupational

Safety and Health; Approval of

Respiratory Devices Used to Protect

Workers in Hazardous Environments

AGENCY: Centers for Disease Control and

Prevention (CDC), National Institute for

Occupational Safety and Health

(NIOSH), Department of Health and

Human Services (DHHS).

ACTION: Notice of public meetings

concerning quality assurance and

administrative approval requirements

for respiratory protective devices.

DATES: August 8, 2000, 9 a.m.–5 p.m., in

the Washington DC Area. August 16,

2000, 9 a.m.–5 p.m., in the San

Francisco, CA Area.

PLACES: 

Washington DC Area—Quality Hotel &

Suites; Courthouse Plaza, Jefferson

Room, 1200 N. Courthouse Road,

Arlington, VA 22201. Phone: 1–888–

987–2555 or 703–524–4000. Phone by

July 21, 2000 to receive the NIOSH

group rate of $118.00.

San Francisco, CA Area—Embassy

Suites, Ambassador Ballroom, 150

Anza Boulevard, Burlingame,

California 94010. Phone: 650–340–

0327. Phone by July 24, 2000 to

receive the NIOSH group rate of

$164.00.

The meetings will be open to the

public, limited only by the space

available. Each meeting room

accommodates approximately 120

people.

Requests to make presentations at the

public meetings should be mailed to the

NIOSH Docket Officer, Robert A. Taft

Laboratories, M/S C34, 4676 Columbia

Parkway, Cincinnati, Ohio 45226,

telephone 513–533–8450, fax 513–533–

8285, or e-mail to

NIOCINDOCKET@CDC.GOV on or

before July 30, 2000.

SUMMARY: The National Institute for

Occupational Safety and Health

(NIOSH) is in the process of developing

a proposed rule on the quality assurance

and administrative requirements for the

approval of respirators and is seeking

individual stakeholder input for this

process. The purpose of these meetings

is to provide an opportunity for an

exchange of information between the

Agency and respirator manufacturers,

industry representatives, labor

representatives, and others with an

interest in respiratory protection.

Attendees will be given an opportunity

to ask questions; submit verbal and

written comments they wish to have

included in the regulatory record; and

provide individual input into potential

changes to the applicable regulations

and policies.

Discussion and Comment Topics

NIOSH has not determined the final

content of its proposed rulemaking but

is considering the regulatory actions

listed below. NIOSH is specifically

asking for comments on these proposed

actions, but would also welcome

comments on additional areas that the

commenters believe may need to be

addressed.

NIOSH is Considering

(1) Proposing quality assurance

requirements for the approval holder’s

manufacturing process that are

consistent with international standards,

specifically the International

Organization for Standards (ISO) 9000

guidelines. These international

standards would be supplemented by

respirator-specific quality measures.

(2) Proposing new quality

requirements, such as mandatory preapproval audits for new manufacturing

sites, more stringent quality sampling

plans, critical classification of defects

for all types of respirators, and records

retention schedules;

(3) Proposing to enhance quality

monitoring activities by NIOSH by

increasing the frequency of both site and

product audits, requiring an approval

holder to supply free product audit

samples for product audits, requiring

approval holders to self-audit their

product and present those results to

NIOSH, accepting ISO certification in

lieu of a NIOSH-performed site audit,

employing contract laboratories to do

certain tests for the approval program,

and requiring the approval holder to

report all customer complaints and noncompliance findings to NIOSH; and

(4) Implementing a new fee structure

to recover costs of approval application

processing (approximately a 2.5 times

increase over the current application

fees), approval records maintenance (a

new annual fee of approximately $36

per approval), and auditing costs (a new

charge computed based on the hourly

rate of government personnel

[approximately $50 per hour] plus

expenses) for the chargeable services

received by the applicant or approval

holder.

Comments on the concepts presented

in this notice should be mailed to the

NIOSH Docket Office, Robert A. Taft

Laboratories, M/S C34, 4676 Columbia

Parkway, Cincinnati, Ohio 45226,

telephone 513–533–8450, fax 513–533–

8285. Comments may also be submitted

by e-mail to:

NIOCINDOCKET@CDC.GOV. E-mail

attachments should be formatted as

WordPerfect 6/7/8/9 or Microsoft Word.

Submitted comments should reference

docket number, NIOSH–001, in the

subject heading.

FOR FURTHER INFORMATION CONTACT: Matt

Bowyer or Roland BerryAnn, NIOSH,

1095 Willowdale Road, Morgantown,

West Virginia 26505–2888, telephone

304–285–5907, fax 304–285–6030 and/

or E-mail:respcert@cdc.gov.

In addition to these public meetings,

NIOSH invites individuals,

organizations and companies to meet

with the staff of its Respirator Branch.

Requests for such meetings should be

made on or before July 31, 2000 to Matt

Bowyer or Roland BerryAnn. NIOSH

will prepare summaries of these

meetings and place them in the

regulatory docket.

Linda Rosenstock,

Director, National Institute for Occupational

Safety and Health, Centers for Disease Control

and Prevention.

[FR Doc. 00–16849 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1359]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Affirmation of

Generally Recognized as Safe (GRAS)

Status

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 information

collection, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements for

reporting and recordkeeping, general

and specific requirements, and

availability of sample electronic product

for manufacturers and distributors of

electronic products.

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41473

DATES: Submit written comments on the

collection of information by September

5, 2000.

ADDRESSES: 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.

Affirmation of Generally Recognized As

Safe (GRAS) Status (21 CFR

170.35(c)(1))—(OMB Control Number

0910–0132)—Extension

Under authority of sections 201, 402,

409, and 701 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

321, 342, 348, and 371), FDA reviews

petitions for affirmation as GRAS that

are submitted on a voluntary basis by

the food industry and other interested

parties. Under section 409 of the act, the

agency has the authority to regulate food

additives. Section 201(s) of the act,

defines ‘‘food additive’’ and expressly

excludes from the definition substances

GRAS for use in food.

Specifically under section 201(s) of

the act, a substance is GRAS if it is

generally recognized among experts

qualified by scientific training and

experience to evaluate its safety, to be

safe through either scientific procedures

or common use in food. The act has

historically been interpreted to permit

food manufacturers to make their own

determination that use of a substance in

food is GRAS. To implement the GRAS

provisions of the act, FDA has issued

procedural regulations under

§ 170.35(c)(1) (21 CFR 170.35(c)(1)).

These regulations establish a process by

which a person may obtain FDA

concurrence with a GRAS

determination; this concurrence is

referred to as ‘‘GRAS affirmation.’’

These regulations set forth the

information to be submitted to FDA to

obtain agency concurrence that a

substance is GRAS (§ 170.35(c)(1)).

GRAS petitions are reviewed by FDA

to ascertain whether the available data

establish that the intended use of the

substance is GRAS based upon either a

history of the safe use of the substance,

or upon widely available safety data

(scientific procedures). The GRAS

affirmation process is a voluntary one,

and there is some risk that FDA may not

agree with the petitioner’s GRAS

determination. The GRAS petition

process does provide a public procedure

for coordinating GRAS determinations.

The process reduces the potential for

public health problems when

substances are marketed based upon

unwarranted safety determinations and

allows a food manufacturer to rely on

the lawful status of a substance that has

been affirmed by FDA as GRAS.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section No. of

respondents

Annual

frequency per

response

Total annual

responses

Hours per

response

Total

hours

170.35(c)(1) 1 1 1 2,614

(average)

2,614

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

FDA estimates that it may receive one

GRAS petition annually. Although the

burden varies with the type, size, and

complexity of the petition submitted,

GRAS petitions may involve analytical

work, analysis of appropriate

toxicological studies, and the work of

drafting the petition itself. Since 1980,

FDA has not received any petitions for

affirmation of GRAS status under 21

CFR part 186—Indirect Food Substances

Affirmed As Generally Recognized As

Safe. Section 184.1(a) (21 CFR 184.1(a))

affirms the use of those substances

affirmed as GRAS in 21 CFR part 184—

Direct Food Substances Affirmed As

Generally Recognized As Safe, for use as

indirect food ingredients.

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16812 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1224]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Guidance

for Industry: Submitting and Reviewing

Complete Responses to Clinical Holds

AGENCY: Food and Drug Administration,

HHS.