10698 Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices

TABLE OF BURDEN ESTIMATES FOR INFORMING PARENTS OF THEIR RIGHTS AND RESPONSIBILITIES AND FOR PROVIDING

TRAINING—Continued

Notifying entity Number of

disclosures

Number of

disclosures

per

disclosure

Average

burden hours

per

disclosure

Average

burden hours

for training

Total burden

hours

TANF Agencies .............................................................................. 3,072 36.507 .166 400 19,017

Legal Aid Agencies and Private Attorneys .................................... 946,500 3.319 .166 36 1,728

Food Stamp Agencies ................................................................... 3,072 3.319 .166 36 1,728

Community Action Agencies .......................................................... 1,158 3.319 .166 36 1,728

Head Start Schools ........................................................................ 37,000 3.319 .166 36 1,728

Secondary Schools ........................................................................ 23,046 3.319 .166 36 1,728

WIC Centers .................................................................................. 1,800 3.319 .166 36 1,728

Estimated Total Annual Burden

Hours: 76,059.

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, D.C. 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: February 12, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–3889 Filed 2–15–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Required Data Elements for

Paternity Establishment Affidavits.

OMB No. 0970–0171.

Description: The Personal

Responsibility and Work Opportunity

Reconciliation Act of 1996 required the

Secretary of the Department of Health

and Human Services to specify the

minimum data elements of an affidavit

to be used for the voluntary

acknowledgment of paternity. States

must enact laws requiring the

development and use of the affidavit

and to give full faith and credit to

affidavits signed in any other State

according to its procedures.

Respondents: State birth record

agencies and State Child Support

Offices.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Affidavit ............................................................................................................ 2,000,000 .2243 .166 74,468

Estimated Total Annual Burden Hours ............................................................ 74,468

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.

Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices 10699

Dated: February 12, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–3890 Filed 2–15–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Radiological Devices Panel of the

Medical Devices Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Radiological Devices

Panel of the Medical Devices Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on March 5, 2001, 9 a.m. to 3:30 p.m.

Location: Corporate Bldg., conference room

020B, 9200 Corporate Blvd., Rockville, MD.

Contact: Robert J. Doyle, Center for Devices

and Radiological Health (HFZ–470), Food

and Drug Administration, 9200 Corporate

Blvd., Rockville, MD 20850, 301–594–1212,

or FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12526. Please

call the Information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss, make

recommendations, and vote on a premarket

approval application for a computer-aided

detection device for identifying regions of

interest in chest radiographs.

Procedure: Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by February 26,

2001. Oral presentations from the public will

be scheduled between approximately 9:15

a.m. and 9:45 a.m., and for an additional 30

minutes near the end of the committee

deliberations. Time allotted for each

presentation may be limited. Those desiring

to make formal oral presentations should

notify the contact person before February 26,

2001, and submit a brief statement of the

general nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and an

indication of the approximate time requested

to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: February 9, 2001.

Bonnie H. Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–4033 Filed 2–15–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D 0994]

Guidance for Industry on BACPAC I:

Intermediates in Drug Substance

Synthesis; Bulk Actives Postapproval

Changes: Chemistry, Manufacturing,

and Controls Documentation;

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 ‘‘BACPAC I: Intermediates in

Drug Substance Synthesis; Bulk Actives

Postapproval Changes: Chemistry,

Manufacturing, and Controls

Documentation.’’ This guidance

provides recommendations to holders of

new drug applications, abbreviated new

drug applications, new animal drug

applications, abbreviated new animal

drug applications, and drug master files

or veterinary master files who intend,

during the postapproval period, to

change the site of manufacture, the scale

of manufacture, the equipment, the

specification(s), and/or the

manufacturing process of intermediates

in the synthetic pathway leading to the

drug substance.

DATES: Submit written comments on

agency guidances at any time.

ADDRESSES: Submit written requests for

single copies of this guidance to the

Drug Information Branch (HFD–210),

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. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

FOR FURTHER INFORMATION CONTACT:

Kasturi Srinivasachar, Center for Drug

Evaluation and Research (HFD–110),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5376; or Dennis M. Bensley,

Center for Veterinary Medicine (HFV–

143), Food and Drug Administration,

7500 Standish Pl., Rockville, MD 20855,

301–827–6956.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled

‘‘BACPAC I: Intermediates in Drug

Substance Synthesis; Bulk Actives

Postapproval Changes: Chemistry,

Manufacturing, and Controls

Documentation.’’ This guidance

describes chemistry, manufacturing, and

controls information and documentation

in support of each change and provides

recommendations on reporting

categories. The guidance applies to

synthetic drug substances and the

synthetic steps involved in the

preparation of semisynthetic drug

substances. It is limited to structurally

well-characterized drug substances

where impurities can be monitored at

the levels recommended. The guidance

covers changes as follows: (1) Site,

scale, and equipment changes involving

the synthetic steps up to, and including,

the step that produces the final

intermediate; (2) specification changes

for raw materials, starting materials, and

intermediates, excluding the final

intermediate; and (3) manufacturing

process changes involving the synthetic

steps up to and including the final

intermediate. The guidance does not

cover postapproval changes affecting:

(1) Synthetic peptides, (2)

oligonucleotides, (3)

radiopharmaceuticals, (4) drug

substances derived exclusively by

isolation from natural sources or

produced by procedures involving

biotechnology, or (5) nonsynthetic steps

for semisynthetic drug substances. Also

excluded from this guidance are certain

changes in specification and process

associated with the use of raw materials

or starting materials derived from

natural sources or biotechnology.

In the Federal Register of November

30, 1998 (63 FR 65793), FDA announced

the availability of a draft version of this

guidance. The November 1998 guidance

gave interested persons an opportunity

to submit comments through March 31,

1999. All comments received during the

comment period have been carefully

reviewed and incorporated in this

revised guidance where appropriate. As

a result of the public comment, the

guidance is clearer and more concise

than the draft version.

This Level 1 guidance is being issued

consistent with FDA’s good guidance