Federal Register / Vol. 62, No. 151 / Wednesday, August 6, 1997 / Notices 42257

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 listed below.

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.

Infant Formula Requirements (21 CFR

106.100, 21 CFR 106.120(b), 21 CFR

107.10(a), 21 CFR 107.20, 21 CFR

107.50(e)(2), 21 CFR 107.50(b)(3), 21

CFR 107.50(b)(4), 21 CFR

107.50(c)(3))—(OMB Control Number

0910–0256)—Extension

Statutory requirements for infant

formula under the Federal Food, Drug,

and Cosmetic Act (the act) are strict to

protect the health of infants and include

a number of reporting and

recordkeeping requirements. Among

other things, section 412 of the act (21

U.S.C. 350a) requires manufacturers of

infant formula to establish and adhere to

quality control procedures, notify FDA

when a batch of infant formula that has

left the manufacturer’s control may be

adulterated or misbranded, and keep

records of distribution. FDA has issued

regulations to implement the act’s

requirements for infant formula in 21

CFR parts 106 and 107.

FDA also regulates the labeling of

infant formula under the authority of

section 403 (21 U.S.C. 343). Under the

labeling regulations for infant formula

in 21 CFR part 107, the label of an infant

formula must include nutrient

information and directions for use. The

purpose of these labeling requirements

is to ensure that consumers have the

information they need to prepare and

use infant formula appropriately.

In a notice published in the Federal

Register of July 9, 1996 (61 FR 36154),

FDA proposed changes in the infant

formula regulations, including some of

those listed below. The notice included

revised burden estimates for the

proposed changes and solicited public

comment. In the interim, however, FDA

is seeking an extension of OMB

approval for the current regulations so

that it can continue to collect

information while the proposal is

pending.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

106.120(b) 4 7 28 10 280

107.10(a)

107.20

107.50(b)(3),(b)(4) 3 4 12 5 60

107.50(e)(2)

Total 340

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

106.100 4 10 40 7,980 31,920

107.50(c)(3)

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

In compiling these estimates, FDA

consulted its records of the number of

infant formula submissions received in

the past. The figures for hours per

response are based on estimates from

experienced persons in the agency and

in industry. Because these infant

formula regulations implement statutory

information collection requirements,

only the additional burden attributable

to the regulations has been included in

the estimates.

Dated: July 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20633 Filed 8–5–97; 8:45 am]

BILLING CODE 4160–01–Fst

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0320]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.
42258 Federal Register / Vol. 62, No. 151 / Wednesday, August 6, 1997 / Notices

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 (the PRA).

DATES: Submit written comments on the

collection of information by September

5, 1997.

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: Desk

Officer for FDA.

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

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

Filing Objections and Requests for a

Hearing on a Regulation or Order—21

CFR Part 12—(OMB Control Number

0910–0184—Extension)

Under section 701(e)(2) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 371(e)(2)), within 30 days

after publication of a regulation or

order, any person adversely affected by

such regulations or order may file

objections and request a public hearing.

The implementing regulations for these

statutory requirements are found at 21

CFR 12.22, which sets forth the format

and instructions for filing objections

and requests for a hearing. Each

objection for which a hearing has been

requested must be separately numbered

and specify with particularity the

provision of the regulation or the

proposed order objected to. In addition,

each objection must include a detailed

description and analysis of the factual

information to be presented in support

of the objection as well as any report or

other document relied on, with some

exceptions. Failure to include this

information constitutes a waiver of the

right to a hearing on that objection. FDA

uses the description and analysis only

for the purpose of determining whether

a hearing request is justified. The

description and analysis do not limit the

evidence that may be presented if a

hearing is granted.

Respondents to this information

collection are those parties that may be

adversely affected by an order or

regulation.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

12.22 60 1 60 20 1,200

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

The burden estimate for this

collection of information is based on

agency data received on this

administrative procedure for the past 3

years. Agency personnel responsible for

processing the filing of objections and

requests for a public hearing on a

specific regulation or order, estimate

approximately 60 requests are received

by the agency annually, with each

requiring approximately 20 hours of

preparation time.

Dated: July 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20600 Filed 8–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Public Workshop on FDA Regulatory

Requirements for the Bioresearch

Industry

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA) (Office of Regulatory Affairs,

Florida District Office, and Center for

Drug Evaluation and Research) is

announcing the following meeting: A

public workshop on FDA regulatory

requirements for the bioresearch

industry. The workshop is designed to

assist the industry in complying with

regulations for institutional review

boards and clinical investigators. FDA’s

survey of the bioresearch industry

shows that many firms are either

unaware of applicable regulations and

guidelines or not in compliance with

applicable requirements.

Date and Time: The meeting will be

held on Monday, September 15, 1997,

8:30 a.m. to 5 p.m.

Location: The meeting will be held at

University of Florida Campus, Reitz

Union—The Rion Ballroom, Museum

Rd., Gainesville, FL 32611.

Contact: Julie D. Bringger,

Jacksonville Resident Post, Food and

Drug Administration, 400 West Bay St.,

Drawer #35069, Jacksonville, FL 32202,

904–232–3596, FAX 904–232–2880.

Registration and Requests for Oral

Presentations: Send registration

information (including name, title, firm

name, address, telephone, and facsimile

number) to the contact person by

September 1, 1997. There is no

registration fee for this workshop. Space

is limited, therefore interested parties

are encouraged to register early.

If you need special accommodations

due to a disability, please contact Julie

D. Bringger at least 7 days in advance.

Dated: July 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20599 Filed 8–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–77]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this