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.

41474 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

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.

DATES: Submit written comments on the

collection of information by August 4,

2000.

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.

Guidance for Industry: Submitting and

Reviewing Complete Responses to

Clinical Holds

On November 21, 1997, the President

signed into law the Food and Drug

Administration Modernization Act (the

Modernization Act) (Public Law 105–

115). Section 117 of the Modernization

Act provides that a written request to

FDA from the applicant of an

investigation that a clinical hold be

removed shall receive a decision in

writing, specifying the reasons for that

decision, within 30 days after receipt of

such request. A clinical hold is an order

issued by FDA to the applicant to delay

a proposed clinical investigation or to

suspend an ongoing investigation for a

drug or biologic. An applicant may

respond to a clinical hold.

Section 505(i)(3)(C) of the Federal

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

355(i)(3)(C)) requires that any written

request to FDA from the sponsor of an

investigation that a clinical hold be

removed must receive a decision, in

writing and specifying the reasons,

within 30 days after receipt of the

request. The request must include

sufficient information to support the

removal of the clinical hold.

In the Federal Register of May 14,

1998 (63 FR 26809), FDA published a

notice of availability of a guidance that

described how applicants should submit

responses to clinical holds so that they

may be identified as complete

responses, and the agency can track the

time to respond. FDA is now issuing a

revised guidance.

The revised guidance states that FDA

will respond in writing within 30

calendar days of receipt of a sponsor’s

request to release a clinical hold and a

complete response to the issue(s) that

led to the clinical hold. An applicant’s

complete response to an investigational

new drug application (IND) clinical

hold is a response in which all clinical

hold issues identified in the clinical

hold letter have been addressed.

The guidance requests that applicants

type in large, bold letters at the top of

the cover letter of the complete response

‘‘Clinical Hold Complete Response’’ to

expedite review of the response. The

guidance also requests that applicants

submit the complete response letter in

triplicate to the IND, and that they fax

a copy of the cover letter to FDA’s

contact, listed in the clinical hold letter,

who is responsible for the IND. The

guidance requests more than an original

and two copies, i.e., three copies, of the

cover letter in order to ensure that the

submission is received and handled in

a timely manner.

Based on data concerning the number

of complete responses to clinical holds

received by the Center for Drug

Evaluation and Research (CDER) from

July 1, 1998, to June 30, 1999, CDER

estimates that approximately 48

responses are submitted annually from

approximately 43 applicants, and that it

takes approximately 284 hours to

prepare and submit to CDER each

response.

Based on data concerning the number

of complete responses to clinical holds

received by the Center for Biologics

Evaluation and Research (CBER) in

fiscal year 1999, CBER estimates that

approximately 134 responses are

submitted annually from approximately

110 applicants, and that it takes

approximately 284 hours to prepare and

submit to CBER each response.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Complete responses to clinical holds No. of

respondents

No. of

responses per

respondent

Total annual

responses

Hours per

response Total hours

CDER 43 approx. 1 48 284 13,632

CBER 110 approx. 1 134 284 38,056

Total 51,688

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

In the Federal Register of April 13,

2000 (65 FR 19911), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16813 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Microbiology Devices Panel of the

Medical Devices Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Microbiology

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 27, 2000, 10:30 a.m. to 5:30

p.m. and July 28, 2000, 8 a.m. to 5 p.m.

Location: Holiday Inn, Walker/

Whetstone Rooms, Two Montgomery

Village Ave., Gaithersburg, MD.