19266 Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 / Notices

as part of this study to identify and

assess the organizational structure and

collaborative efforts that contribute to

the ability of CBOs to access their target

populations, deliver HIV prevention

services, and provide referrals over a

sustained period of time. For the

purposes of this study, a CBO is defined

as any not-for-profit organization that

provides direct prevention services to

persons at high risk for infection within

a designated area. Evaluation is

necessary to understand the impacts of

CDC’s expenditures and efforts to

support CBOs, and for modifying and

improving the prevention efforts of

CBOs.

Interviews and document reviews will

be conducted with community-based

organizations, health departments,

collaborating organizations, other

organizations in the community, and

community members in seven

geographical areas at four different

points in time. Four CBOs from each

area will be included in the study. The

first wave of data collection is planned

for the summer 1998, and data

collection will end during the winter of

2000. The total burden in hours is

estimated at 10,080.

Respondents Number of

respondents

Number of

responses/

respondent

Average

burden/response (in

hrs.)

Total burden (in hrs.)

CBOs ................................................................................................................................ 224 4 1 896

Health Department ........................................................................................................... 56 4 1 224

Collaborating Organizations ............................................................................................. 840 4 1 3360

Other Community ............................................................................................................. 840 4 1 3360

Community Members ....................................................................................................... 560 4 1 2240

Total ....................................................................................................................... .................... .................... .................... 10080

3. PHS Supplements to the

Application for Federal Assistance SF

424 (0920–0428)—Extension—The

Centers for Disease Control and

Prevention (CDC) is requesting a threeyear extension and revision of OMB

approval for continued use of the

Supplements to the Request for Federal

Assistance Application (SF–424). We

also plan on modifying the SF 424 form.

The Checklist, Program Narrative, and

the Public Health System Impact

Statement (third party notification)

(PHSIS) are a part of the standard

application for State and local

governments and for private non-profit

and for-profit organizations when

applying for financial assistance from

PHS grant programs. The Checklist

assists applicants to ensure that they

have included all required information

necessary to process the application.

The Checklist data helps to reduce the

time required to process and review

grant applications, expediting the

issuance of grant awards. The PHSIS

Third Party Notification Form is used to

inform State and local health agencies of

community-based proposals submitted

by non-governmental applicants for

Federal funding.

The current OMB approval for the

supplements was previously submitted

by the Department of Health and Human

Services, Office of the Assistant

Secretary of Health (OASH) under OMB

number 0937–0189. The total annual

cost to the respondents is $1,184,452.

Respondents No. of respondents

No. of responses/respondent

Avg. burden/response (in

hrs.)

Total burden (in hrs.)

State and local health departments; non-profit and for-profit organizations .................... 7,643 1 4.215 32,215

Total ....................................................................................................................... .................... .................... .................... 32,215

Dated: April 13, 1998.

Kathy Cahill,

Associate Director for Policy Planning and

Evaluation, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–10195 Filed 4–16–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: National Directory of New Hires

Reporting Results Survey.

OMB No.: New Collection.

Description: Pub. L. 104–193, the

‘‘Personal Responsibility and Work

Opportunity Reconciliation Act of

1996,’’ required the Office of Child

Support Enforcement (OCSE) to develop

a National Directory of New Hires

(NDNH) to improve the ability of State

child support agencies to locate

noncustodial parents and collect child

support across State lines. In order to

encourage continued and even

improved cooperation with the

requirements of the program, OCSE

would like to conduct a brief telephone

survey to solicit any information already

collected by the States as to improve

collection and other programmatic

savings attributable to the program. That

information would then be condensed

into a report to be published through

newsletters or press releases.

Respondents: State, Local or Tribal

Govt.
Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 / Notices 19267

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

New Hire Results Survey ................................................................................. 54 4 .5 108

Estimated Total Annual Burden

Hours: 108.

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

370 L’Enfant Promenade, SW,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: April 13, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–10188 Filed 4–16–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0193]

Draft Guidance for Industry on

Manufacturing, Processing, or Holding

Active Pharmaceutical Ingredients;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Manufacturing,

Processing, or Holding Active

Pharmaceutical Ingredients.’’ This draft

guidance is intended to provide

guidance on current good

manufacturing practices (CGMP’s) for

manufacturing, processing, packing, or

holding active pharmaceutical

ingredients (API’s). The draft guidance

is intended to help ensure the quality

and suitability of API’s for use in the

manufacture of drug products.

DATES: Written comments may be

submitted on the draft guidance by May

18, 1998. General comments on agency

guidances are welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/cber/

guidelines.htm.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Edwin M. Rivera, Center for Drug

Evaluation and Research (HFD–322),

7520 Standish Pl., Rockville, MD 20855,

301–594–0095; John A. Eltermann,

Center for Biologics Evaluation and

Research (HFM–205), 1401 Rockville

Pike, Rockville, MD 20852, 301–827–

3031; or Jose R. Laureano, Center for

Veterinary Medicine (HFV–230), 7500

Standish Pl., Rockville, MD 20855, 301–

594–1785.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled

‘‘Manufacturing, Processing, or Holding

Active Pharmaceutical Ingredients.’’ It

provides guidance on CGMP’s for the

manufacture, processing, packing, or

holding (i.e., storage) of API’s.

The draft guidance is a result of

extensive efforts that began in July 1995

when FDA decided to develop an

industry guidance for the manufacture

and control of API’s. An initial draft of

this guidance for industry was widely

distributed during 1996. It was reviewed

at a September 1996 international

conference on API’s in Canberra,

Australia, sponsored by the

Pharmaceutical Inspection Convention/

Pharmaceutical Inspection Convention

Scheme (PIC–PIC/S), and at the October

1996 annual FDA/Parenteral Drug

Association Forum in Bethesda, MD. It

also was distributed to numerous

pharmaceutical trade associations in a

letter from the Center for Drug

Evaluation and Research’s (CDER)

Office of Compliance, dated November

8, 1996. The initial draft was posted on

CDER’s website on November 12, 1996,

with a request for comments by

December 10, 1996. On December 9, the

deadline for comments was extended

until January 31, 1997. This draft

guidance incorporates recommendations

received at the two conferences and

comments from 27 organizations,

including API manufacturers, dosage

manufacturers, and pharmaceutical

associations.

At a February 4 and 5, 1998, meeting

of the International Conference on

Harmonisation (ICH) Steering

Committee in Tyson’s Corner, VA, FDA

supported the decision to develop

internationally harmonized guidance on

CGMP’s for API’s through the ICH

process. The agency agreed to

participate in an expert working group

that will review numerous guidance

documents developed by industry and

regulatory bodies to develop a single

harmonized ICH guidance. API/CGMP

guidances to be reviewed by the

working group include those prepared

by the European Chemical Industry

Council/European Federation of

Pharmaceutical Industries’ Association,

the Pharmaceutical Research and

Manufacturers of America, PIC–PIC/S,

and the World Health Organization.

This draft guidance will also be

considered by the working group.

The draft guidance applies to the

manufacture and control of drug and

biologic API’s for use in human and

veterinary drug products. In addition, it

applies to the later chemical isolation

and purification steps of API’s derived

from biological or fermentation

processes and to sterile API’s, but only

up to the point where the API is