65976 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices

each function or activity in such terms

as the number of people to be served

and the number of activities

accomplished. When accomplishments

cannot be quantified by activity or

function, list them in chronological

order to show the schedule of

accomplishments and their target dates.

If any data is to be collected,

maintained, and/or disseminated,

clearance may be required from the U.S.

Office of Management and Budget

(OMB). This clearance pertains to any

‘‘collection of information that is

conducted or sponsored by ACF.’’

List organizations, cooperating

entities, consultants, or other key

individuals who will work on the

project along with a short description of

the nature of their effort or contribution.

Criterion 4. Budget and Budget

Justification (15 points)

Provide line item detail and detailed

calculations for each budget object class

identified on the Budget Information

form. Detailed calculations must

include estimated methods, quantities,

unit costs, and other similar quantitative

detail sufficient for the calculation to be

duplicated. The detailed budget must

also include by the funding sources

identified in Block 15 of the SF–424.

Provide a narrative budget

justification that describes how the

categorical costs are derived. Discuss

the necessity, reasonableness, and

allocability of the proposed costs.

Required Notification of the State

Single Point of Contact

This program is covered under

Executive Order 12372,

Intergovernmental Review of Federal

Programs and 45 CFR part 100,

Intergovernmental Review of

Department of Health and Human

Services Program and Activities. Under

the Order, States may design their own

processes for reviewing and

commenting on proposed Federal

assistance under covered programs.

All States and Territories except

Alabama, Alaska, Colorado,

Connecticut, Hawaii, Idaho, Kansas,

Louisiana, Massachusetts, Minnesota,

Montana, Nebraska, New Jersey, New

York, Ohio, Oklahoma, Oregon,

Pennsylvania, South Dakota, Tennessee,

Vermont, Virginia, Washington,

American Samoa, and Palau have

elected to participate in the Executive

Order process and have established

Single Points of Contact (SPOCs).

Applicants from these twenty-five

jurisdictions need take no action

regarding E.O. 12372. Applicants for

projects to be administered by

Federally-recognized Indian Tribes are

also exempt from the requirements of

E.O. 12372. Otherwise, applicants

should contact their SPOCs as soon as

possible to alert them of the prospective

applicants and receive any necessary

instructions. Applicants must submit

any required material to the SPOCs as

soon as possible so that the program

office can obtain and review SPOC

comments as part of the award process.

It is imperative that the applicant

submit all required materials, if any, to

the SPOC and indicate the date of this

submittal (or the date or contact if no

submittal is required) on the Standard

Form 424, Item 16a.

Under 45 CFR 100.8(a)(2), a SPOC has

60 days from the application deadline to

comment on proposed new or

competing continuation awards.

SPOCs are encouraged to eliminate

the submission of routine endorsements

as official recommendations.

Additionally, SPOCs are requested to

clearly differentiate between mere

advisory comments and those official

State recommendations which may

trigger the ‘‘accommodate or explain’’

rule.

When comments are submitted

directly to ACF, they should be

addressed to: William Wilson, Head

Start Bureau, 330 C Street, SW.,

Washington, DC 20447, Attn: Head

Start—Child Development Associate

Credentialing Program.

A list of Single Points of Contact for

each State and Territory can be found

on the web site. http://

www.whitehouse.gov/omb/grants/

spoc.html.

Dated: December 18, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–31500 Filed 12–20–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

FDA Food Labeling and Allergen

Declaration; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA), Southwest

Regional Small Business Program (Small

Business Program), Office of Regulatory

Affairs, in collaboration with FDA’s

Center for Food Safety and Applied

Nutrition, the State of Missouri

Department of Public Health, the Kansas

City Department of Health and the

Missouri Milk, Food and Environmental

Health Association is announcing a

public workshop entitled ‘‘FDA Food

Labeling and Allergen Declaration.’’

This public workshop is intended to

provide information about FDA food

regulations, food labeling allergen

declaration, good manufacturing

practices, and other related matters to

the regulated industry, particularly

small businesses and startups.

Date and Time: The public workshop

will be held on January 10 and 11, 2001,

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

Location: The public workshop will

be held at the Kansas City Department

of Health Auditorium, 2400 Troost Ave.,

Kansas City, MO.

Contact: Gala Jaramillo, Missouri

Milk, Food and Environmental Health

Association, P.O. Box 105017, Jefferson

City, MO 65110–5017, 573–634–6418,

or Sue Thomason, FDA, 7920 Elmbrook

Dr., suite 102, Dallas, TX 75247–4982,

214–655–8100, ext. 128, FAX 214–655–

8114.

Registration: Preregistration by

January 3, 2002, is encouraged. The

Missouri Milk, Food and Environmental

Health Association has a $20

preregistration fee to cover the cost of

breaks. To preregister, please complete

the form below and send along with a

check or money order for $20 payable to

The Missouri Milk, Food and

Environmental Health Association

(address above). As an alternative, the

registration form and directions to the

facility can also be obtained on the

Internet at http://www.fda.gov/ora/

indust_assit/Default.htm. Seats are

limited, please submit registration form

as soon as possible. Course space will be

filled in order of receipt of registration.

Those accepted into the course will

receive written confirmation.

Registration will close when the course

is filled. Registration at the site will be

done on a space available basis on the

day of the public workshop beginning at

8 a.m. The cost of registration at the site

is $25 payable to The Missouri Milk,

Food and Environmental Health

Association. If you need special

accommodations due to a disability,

please contact Leslie Foresberg at 816–

513–6315 at least 7 days in advance.

Name: llllll

Agency: llllll

Mailing Address: llllll

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices 65977

City: llllll

State: llllll

Zip Code: llllll

Phone: ( ) llllll

FAX: ( ) llllll

E-mail: llllll

Transcripts: Transcripts of the public

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

public workshop at a cost of 10 cents

per page.

SUPPLEMENTARY INFORMATION: The

workshop is being held in response to

a request by the State of Missouri to

present information that would be

helpful to regulated industry. The Small

Business Program presents this

workshop to help achieve objectives set

forth in section 406 of the Food and

Drug Administration Modernization Act

of 1997 (21 U.S.C. 393), which include

working closely with stakeholders and

maximizing the availability and clarity

of information to stakeholders and the

public. This is consistent with the

purposes of the Small Business

Program, which are in part to respond

to industry inquiries, develop

educational materials, sponsor

workshops and conferences to provide

firms, particularly small businesses,

with firsthand working knowledge of

FDA’s requirements and compliance

policies. This workshop is also

consistent with the Small Business

Regulatory Enforcement Fairness Act of

1996 (Public Law 104–121), as outreach

activities by Government agencies to

small businesses.

The goal of the workshop is to present

information that will enable

manufacturers and regulated industry to

better comply with labeling

requirements, especially in light of

growing concerns about food allergens.

Information presented will be based on

agency position as articulated through

regulation, compliance policy guides,

and information previously made

available to the public. Topics to be

discussed at the workshop include: (1)

FDA food regulations, (2) food labeling,

(3) allergen declaration, (4) good

manufacturing practices, and (5) the

Nutrition Labeling Education Act. FDA

expects that participation in this

workshop will provide regulated

industry with greater understanding of

the regulatory and policy perspectives

on food labeling and allergen

declaration.

Dated: December 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31572 Filed 12–19–01; 12:37

pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0465]

Guidance for Industry on Major, Minor,

and Telephone Amendments to

Abbreviated New Drug Applications;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Major, Minor, and Telephone

Amendments to Abbreviated New Drug

Applications.’’ This guidance is a

second revision of the guidance entitled

‘‘Major, Minor, FAX, and Telephone

Amendments to Original Abbreviated

New Drug Applications.’’ FDA’s Office

of Generic Drugs (OGD) determined that

further revision of the policy regarding

determination of major, minor, and

telephone amendments was necessary to

help streamline the review of

abbreviated new drug applications

(ANDAs).

DATES: Submit written or electronic

comments on the guidance by March 21,

2002. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Submit written requests for

single copies of this guidance to the

Division of Drug Information (HFD–

240), Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

electronic comments to http://

www.fda.gov/dockets/ecomments. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the guidance

document.

FOR FURTHER INFORMATION CONTACT: Rita

R. Hassall, Center for Drug Evaluation

and Research (HFD–600), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

5845.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled ‘‘Major,

Minor, and Telephone Amendments to

Abbreviated New Drug Applications.’’

The guidance is intended to document

OGDs policy regarding the

determination of major, minor, and

telephone amendments to original and

supplemental ANDAs. This guidance

first published in August 1999 and was

originally entitled ‘‘Major, Minor, FAX,

and Telephone Amendments to Original

Abbreviated New Drug Applications.’’ It

was revised in May 2000 to explain that

the issuance of a major, minor, or FAX

amendment would stop the review

clock.

The second revision of this guidance

(1) deletes the FAX amendment

designation, which was found to be

unnecessary, (2) now applies to

supplemental applications as well, and

(3) changes the criteria for determining

the type of amendment. The changes in

criteria should result in more

amendments being categorized as

‘‘minor’’ and fewer as ‘‘major.’’ A minor

amendment request (generally reviewed

within 30 to 60 days) has a higher

priority than a major amendment. Since

the review of a minor amendment takes

place sooner than a major amendment

after the original review, there is not a

long break in the review process for a

minor amendment. The response to a

major amendment request, however,

goes into the 180-day queue. This

process causes a greater time lapse from

when the original review was done and

results in reviewers having to

refamiliarize themselves with the

application. It is expected that the new

policy will help in moving applications

through the approval process more

quickly than under the previous policy.

Thus the total time for approval of

ANDAs will be reduced.

Because it lessens the burden on

industry, this guidance is being issued

as a Level 1 guidance for immediate

implementation, consistent with FDA’s

good guidance practices regulation (21

CFR 10.115). As with other Level 1

guidances for immediate