42256 Federal Register / Vol. 62, No. 151 / Wednesday, August 6, 1997 / Notices

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: July 29, 1997.

Bob Driscoll,

Reports Clearance Officer.

[FR Doc. 97–20679 Filed 8–5–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: State Developmental Disabilities

Council Annual Program Performance

Report.

OMB No.: 0980–0172.

Description: Section 107 of the DD

Act requires the State DD Councils of

each State to prepare and transmit to the

Secretary, DHHS, an annual Report for

the preceding fiscal year. It is to

describe the activities and resultant

accomplishments carried out with Part

B funds received for the Federal fiscal

year, and the general situation in the

States for individuals with

developmental disabilities. The

information is necessary for annual

technical assistance and monitoring, as

well as, preparation of the Secretary’s

Annual Report to the President, the

Congress, and the National Council on

Disabilities.

Respondents: Individuals and

Households; Not-for-Profit Institutions;

and State, Local or Tribal Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average burden hours

per response

Total

burden

hours

DD Council PPR ....................................................................................................... 55 1 44 2,240

Estimated total annual burden hours: ............................................................... ...................... ...................... ...................... 2,420

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Service, 370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Ms.

Wendy Taylor.

Dated: July 29, 1997.

Robert Driscoll,

Reports Clearance Officer.

[FR Doc. 97–20680 Filed 8–5–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0309]

Agency Information Collection

Activities: Proposed Collection;

Extension

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

information collection regarding the

manufacture of infant formula,

including infant formula labeling,

quality control procedures, notification

requirements, and recordkeeping.

DATES: Submit written comments on the

collection of information by October 6,

1997.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, 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
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.