49244 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

Office contributes to the development of

national policy based on regional

perspectives for all ACF programs. It

oversees ACF operations and the

management of ACF regional staff;

coordinates activities across regional

programs; and assures that goals and

objectives are carried out. The Office

alerts the Assistant Secretary for

Children and Families to problems and

issues that may have significant regional

or national impact. It represents ACF at

the regional level in executive

communications within ACF, with the

HHS Regional Director, other HHS

operating divisions, other federal

agencies, and public or private local

organizations representing children and

families.

Within the Office of the Regional Hub

Director, an administrative staff assists

the Regional Hub Director. The staff

directs the development of regional

work plans related to the overall ACF

strategic plan; tracks, monitors and

reports on regional progress in the

attainment of ACF national goals and

objectives; and manages special and

sensitive projects. It serves as the focal

point for public affairs and contacts

with the media, public awareness

activities, information dissemination

and education campaigns in accordance

with the ACF Office of Public Affairs

and in conjunction with the HHS

Regional Director; and assists the

Regional Hub Director in the

management of cross-cutting initiatives

and activities among the regional

components.

The Office provides day-to-day

support for regional administrative

functions, oversees the management and

coordination of automated systems in

the region, and provides data

management support to all Regional

Office components. Administrative

functions include budget planning and

execution, facility management,

employee relations, and human

resources development. Data

management responsibilities include the

development of automated systems

application to support and enhance

program, fiscal, and administrative

operation, and the compilation and

analysis of data on demographic and

service trends that assist in monitoring

and oversight responsibilities.

The Office is responsible for the

effective and efficient management of

internal ACF automation process. Staff

performs an independent grants

management function to support the

grants processing in the office.

B. The Office of Self-Sufficiency

Programs is headed by an Assistant

Regional Administrator who reports to

the Regional Hub Director and consists

of Child Support Enforcement Branch;

Child Welfare Branch; and Family

Independence/Child Care Branch.

The Office is responsible for

providing centralized program, financial

management and technical

administration of certain ACF formula,

entitlement, discretionary and block

grant programs, such as Temporary

Assistance for Needy Families, Child

Support Enforcement, Child Care and

Development Fund, Child Welfare

Services, Family Preservation and

Support, Foster Care and Adoption

Assistance, and Child Abuse and

Neglect and for oversight of state

systems projects for ACF programs. In

coordination with other Regional Office

components, it monitors state systems

projects and is the focal point for

technical assistance to states and

grantees on the development and

enhancement of automated systems.

In that regard the Office provides

policy guidance to states to assure

consistent and uniform adherence to

federal requirements governing formula

and entitlement programs. The Office

reviews cost estimates and reports from

ACF entitlement and formula grant

programs, and recommends funding

levels.

A Financial/Grants Management

Officer is located in each Branch of the

Office of Self-Sufficiency Programs to

provide expertise in business and other

non-programmatic areas of grants

administration and to help ensure that

grantees fulfill requirements of law,

regulations and administrative policies.

The Office establishes regional

financial management priorities;

reviews cost allocation plans, and

makes recommendations to the Regional

Hub Director to approve, defer or

disallow claims for federal financial

participation in ACF formula and

entitlement programs. As applicable, it

makes recommendations on the

clearance and closure of audits of state

and grantee programs, paying particular

attention to deficiencies that decrease

the efficiency and effectiveness of ACF

programs and taking steps to resolve

such deficiencies.

The Office represents the Regional

Hub Director in dealing with ACF

central office, states and grantees on all

program and financial management

policy matters for programs under its

jurisdiction. It alerts the Regional Hub

Director to problems or issues that have

significant implications for the

programs.

C. The Office of Community Programs

is headed by an Assistant Regional

Administrator who reports to the

Regional Hub Director and consists of

three Head Start and Youth Branches.

The Office is responsible for

providing centralized program, financial

management and technical

administration of certain ACF

discretionary programs, such as Head

Start and Runaway and Homeless

Youth, as well as the Developmental

Disabilities program.

A Financial/Grants Management

Officer is located in each Branch of the

Office of Community Programs to

provide expertise in business and other

non-programmatic areas of grants

administration and to help ensure that

grantees fulfill requirements of law,

regulations and administrative policies.

The Office establishes regional

financial management priorities;

reviews cost allocation plans, and

makes recommendations to the Regional

Hub Director to approve or disallow

costs under ACF discretionary grant

programs. The Office issues certain

discretionary grant awards based on a

review of project objectives, budget

projections and proposed funding

levels. As applicable, it makes

recommendations on the clearance and

closure of audits of state and grantee

programs, paying particular attention to

deficiencies that decrease the efficiency

and effectiveness of ACF programs and

taking steps to resolve such deficiencies.

The Office represents the Regional

Hub Director in dealing with ACF

central office, states and grantees on all

program and financial management

policy matters for programs under its

jurisdiction. It alerts the Regional Hub

Director to problems or issues that have

significant implications for the

programs.

Dated: September 12, 1997.

Olivia A. Golden,

Principal Deputy Assistant Secretary for

Children and Families.

[FR Doc. 97–24989 Filed 9–18–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0182]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collections of

information listed below have been
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices 49245

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 October 20,

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:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

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

submitted the following proposed

collections of information to OMB for

review and clearance.

1. Requests for Samples and Protocols:

Official Release—(OMB Control

Number 0910–0206—Reinstatement)

Under section 351 of the Public

Health Service Act (the PHS Act) (42

U.S.C. 262), FDA has the responsibility

to issue regulations that prescribe

standards designed to assure the safety,

purity, and potency of biological

products and to ensure that licenses for

such products are only issued when a

product meets the prescribed standards.

Since January 8, 1948, there has been

a regulation, now codified under § 610.2

(21 CFR 610.2), that gives authority to

FDA to require manufacturers of

licensed biological products to submit

lot samples and protocols prior to

marketing the lot of product. These lot

samples and protocols are required by

FDA when necessary for the safety,

purity, or potency of the product. This

requirement remains essential because

of the potential lot-to-lot variability of

many biological products. In cases of

certain biological products (e.g.,

Albumin, Plasma Protein Fraction, and

specified biotechnology and specified

synthetic biological products) that are

known to have lot-to-lot stability,

official lot release is normally not

required. In addition to § 610.2, there

are other regulations that require

additional standards for the submission

of samples and protocols for specific

licensed biological products:

§§ 640.101(f) (21 CFR 640.101(f))

(Immune Globulin (Human)), 660.6 (21

CFR 660.6) (Antibody to Hepatitis B

Surface Antigen), 660.36 (21 CFR

660.36) (Reagent Red Blood Cells), and

660.46 (21 CFR 660.46) (Hepatitis B

Surface Antigen).

Respondents to this collection of

information are manufacturers of

licensed biological products that are

subject to lot release. Approximately 80

manufacturers are subject to lot release.

Previously, 90 firms were subject to lot

release, however, 10 of those firms have

been exempted from this reporting

requirement because the firms

manufacture specified biotechnology

and/or specified synthetic biological

products. FDA estimates are based on

data on lot releases submitted in fiscal

year 1995. The estimated burdens for

§§ 640.101(f), 660.6, 660.36, and 660.46

are included in the estimated annual

reporting burden for § 610.2.

In the Federal Register of May 30,

1997 (62 FR 29353), the agency

requested comments on the proposed

collection of information for ‘‘Requests

for Samples and Protocols: Official

Release.’’ The agency received one

comment, which suggested a higher

estimated average for the time to

prepare a protocol for submission to

FDA than the agency had estimated.

Subsequently, FDA contacted another

representative from industry in August

1997 regarding the lot release

requirements for § 610.2. The average

time estimated herein was adjusted

accordingly to reflect the comment

received and all four contacts with

industry. The burden estimate ranged

from 1 to 5.6 hours and the average was

rounded to 3 hours.

FDA estimates the burden of this

information collection 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

610.2 80 75 6,500 1 6,500

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

2. Transmittal of Labels and Circulars,

Form FDA 2567—21 CFR 601.2(a) and

601.12(a) (OMB Control Number 0910–

0039—Reinstatement)

Under section 351 of the PHS Act,

FDA reviews the labeling for biological

products prior to marketing of the

licensed product and when changes to

labeling are proposed. Section 601.2(a)

(21 CFR 601.2(a)) requires

manufacturers of biological products to

submit an establishment and product, or

biologics license application for review

and approval to the Center for Biologics

Evaluation and Research (CBER) prior to

marketing a biological product in

interstate commerce. Specimens of the

label are required to be submitted as

part of the approval process. Section

601.12(a) (21 CFR 601.12(a)) requires

proposed changes to labeling to be

submitted to CBER for approval. For

these labeling requirements, Form FDA

2567 is used to determine the type of

labeling being submitted (container

label, package label, diluent label and/

or circular) and the type of change(s) to

the labeling. This form is also used for

the submission of advertising and

promotion labeling. The form is

composed of two parts: Part I is for the

submission of draft and preliminary

proof labeling and is completed by

manufacturers of biological products,

and Part II of the form is submitted

upon implementation of final printed

labeling. Parts I and II of the form are

submitted separately. Respondents to

this collection of information are

manufacturers of biological products.

FDA estimates the burden of this

collection of information as follows:
49246 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN

Form No. 21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA Form 2657

Transmittal of Labels

and Circulars 601.2(a) and 601.12(a) 387 7.2 2,800 .16 448

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

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24954 Filed 9–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0378]

Food Code; 1997 Revision; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the 1997 revision of the

Food Code. This 1997 revision was

initiated in cooperation with the

Conference for Food Protection (CFP) to

help ensure that safe, unadulterated,

and honestly presented food is sold or

offered for human consumption by retail

food establishments.

ADDRESSES: The 1997 revision of the

Food Code is available for public

examination in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Regarding questions about this

document: Betty Harden, Office of

Field Programs, Center for Food

Safety and Applied Nutrition (HFS–

627), 200 C St. SW., Washington,

DC 20204, 202–205–8140.

Regarding additional information

about the CFP: Leon Townsend,

Conference for Food Protection, 110

Tecumseh Trail, Frankfort, KY

40601, 502–695–0253.

SUPPLEMENTARY INFORMATION: FDA

provides assistance to local, State, and

Federal governmental bodies to ensure

that the food that is provided to

consumers by retail food establishments

is not a vector of communicable

diseases. One mechanism for providing

that assistance is the publication of a

model code that sets out FDA’s best

advice for a uniform system of

regulation to ensure that the food sold

or offered for human consumption at

retail is safe, properly protected, and

accurately presented.

The CFP was originally established in

1971 by State and Federal officials and

by representatives of industry. In 1988,

the CFP adopted a constitution and bylaws to provide a formal structure under

which State regulatory authorities could

meet and consider guidelines for

improving food safety in the retail

segment of the food industry.

At the 1986 CFP meeting, FDA

presented a White Paper that

recommended combining the three

distinct model codes that existed at that

time (retail food stores, food service

facilities, and vending) into a Food

Protection Unicode. The CFP endorsed

the approach that FDA would develop

a model Food Protection Unicode as a

priority project. FDA formed a Unicode

Task Group and published a notice of

the Unicode’s availability for comment

in the Federal Register of May 9, 1988

(53 FR 16472), when the Task Group

completed a draft. Based on comments

submitted in response to that notice,

and in consideration of subsequent

comments provided by regulatory

officials, industry representatives,

academia, and consumer representatives

at the CFP meetings in 1988, 1990, and

1992, FDA modified the document and

finalized it as the 1993 Food Code.

Based on field application trials, further

comment, and input from the 1994 CFP

meeting, FDA issued a revised version

of the 1993 Food Code as the 1995 Food

Code.

The CFP wrote a letter to FDA on May

28, 1996, and suggested changes in the

1995 Food Code. The CFP developed

these suggestions in cooperation with

the Association of Food and Drug

Officials (AFDO).

The 1997 Food Code responds to

those suggestions. Noteworthy changes

from the 1995 Food Code include the

following:

(1) Modification of the definition of

potentially hazardous food to

specifically state that a food might

contain pathogens even though it does

not qualify as a potentially hazardous

food;

(2) Identification of three methods of

complying with the knowledge

requirements for the person in charge;

(3) Addition of Shigella spp. and E.

coli O157:H7 to the list of organisms

that warrant restriction or exclusion if a

food worker is found to be an

asymptomatic shedder;

(4) Removal of the special

handwashing procedures and

reservation of that section;

(5) Allowance for the storage of

potentially hazardous food at 45 °F (7

°C) under certain conditions;

(6) Adjustment of the number of days

that prepared foods may be stored at 41

°F (5 °C) and 45 °F from 10 to 7 and

from 3 to 4, respectively;

(7) Revision of certain cooking

temperatures and times, e.g., for

preparing ratites and formed roast beef

and for microwave cooking;

(8) Modifications throughout the

document to coincide with the seafood

hazard analysis critical control point

rule at 21 CFR parts 123 and 1240;

(9) Provision for the regulatory

authority to approve alternatives to the

rule of no bare hand contact with readyto-eat food;

(10) Insertion of an explanation of the

current status of the consumer advisory

language recommended by the CFP;

(11) Use of the term ‘‘raw shell eggs’’

to distinguish provisions that apply to

in-shell eggs versus in-shell eggs that

were subjected to in-shell pasteurization

at a food processing plant;

(12) Addition of a statement that shell

eggs placed, upon receipt, in a

refrigerated unit that maintains food at

the required temperature constitutes

satisfactory compliance;

(13) Addition of a section that collates

and expands the Food Code’s special

precautions for highly susceptible

populations;

(14) Removal of the requirement for a

specified carbonator backflow

prevention device and reservation of the

section; and

(15) Update of information and

addition of user aides in the annexes.

The 1997 revision of the Food Code

is available for public examination in