11898 Federal Register / Vol. 62, No. 49 / Thursday, March 13, 1997 / Notices

team and the Minority Male (Min-Male)

Consortium.

(5) Central State University will

convene a meeting with the Advisory

Board and the Family Life Center

Directors three times a year.

(6) Central State University will

monitor the activities of the funded

institutions to ensure compliance with

the intent of the program.

(7) Central State University will

conduct a yearly evaluation of the

activities of each of the funded

institutions, as well as the overall

project.

OMH Responsibilities

Substantial programmatic

involvement is as follows:

(1) OMH will provide technical

assistance and oversight as necessary for

the overall design of the Family and

Community Violence Prevention

Program.

(2) OMH will develop the evaluation

criterion for the selection and funding of

applications.

(3) OMH will manage the review and

selection of applications and ensure the

absence of conflict of interest in the

review process.

(4) OMH will have final approval of

the Advisory Board membership.

(5) OMH will provide assistance to

the Management Team on program

strategies, direction, evaluation

activities, and decisions related to

adjustments in funding levels of

participating institutions.

(6) OMH will participate in the

planning of and attend all of the

Advisory Board/Family Life Center

Directors meetings.

(7) OMH will participate in site visits

to the participating institutions as

deemed appropriate by OMH staff.

WHERE TO OBTAIN ADDITIONAL

INFORMATION: If you are interested in

obtaining additional information

regarding this project, contact Ms.

Cynthia H. Amis, Director, Division of

Program Operations, Office of Minority

Health, 5515 Security Lane, Suite 1000,

Rockville, Maryland 20852, telephone

number (301) 594–0769.

The Catalog of Federal Domestic

Assistance number is 93.910.

Clay E. Simpson, Jr.,

Deputy Assistant Secretary for Minority

Health.

[FR Doc. 97–6325 Filed 3–12–97; 8:45 am]

BILLING CODE 4160–17–M

Food and Drug Administration

[Docket No. 96N–0402]

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 collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by April 14,

1997.

ADDRESSES: Submit written comments

on the collection of information to

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:

Linda L. Brna, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–3158.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507), FDA has submitted the

following proposed collection of

information to OMB for review and

clearance.

Blood Establishment Registration and

Product Listing, Form FDA 2830 (21

CFR Part 607) (OMB Control Number

0910–0052)

Under section 510 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360), any person owning or

operating an establishment that

manufactures, prepares, propagates,

compounds, or processes a drug or

device must register with the Secretary

of Health and Human Services, on or

before December 31 of each year, his or

her name, place of business and all such

establishments, and submit, among

other information, a listing of all drug or

device products manufactured,

prepared, propagated, compounded, or

processed by him or her for commercial

distribution. In 21 CFR part 607, FDA

has issued regulations implementing

these requirements for manufacturers of

human blood and blood products.

Under these regulations, the agency

seeks the information required by the

act, including the location of the

facility, name of the reporting official,

type of ownership, type of

establishment, and identification of

blood and blood products being

manufactured. Among other uses, this

information assists FDA in its

inspections of facilities, and its

collection is essential to the overall

regulatory scheme designed to ensure

the safety of the nation’s blood supply.

Form FDA 2830, Blood Establishment

Registration and Product Listing, is used

to collect this information. The likely

respondents are blood banks, blood

collection facilities, and blood

component manufacturing facilities.

FDA estimates the burden of this

collection of information as follows:

Based upon the past experience of the

Center for Biologics Evaluation and

Research, Division of Blood

Applications, in regulatory blood

establishment registration and product

listing with new blood banks, the time

needed for industry to complete the

FDA 2830 is estimated to be 1 hour. For

annual re-registration of blood banks,

the time needed for industry to

complete the FDA 2830 form is

estimated to be one-half hour because

re-registrants only need to refer to their

files or written instructions for a small

portion of the information required.

Blood banks should be familiar with the

regulations and registration

requirements to fill out this form.

ESTIMATED ANNUAL REPORTING BURDEN

Form No. FDA 2830 (21 CFR Part 607) No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Initial registration 300 1 300 1 300

Re-registration 3,000 1 3,000 0.5 1,500

Total 3,300 3,300 1,800

There are no capital costs or operating and maintenance costs associated with this collection.
Federal Register / Vol. 62, No. 49 / Thursday, March 13, 1997 / Notices 11899

Dated: March 5, 1997

William K. Hubbard,

Associate Commissioner for Policy

Coordination

[FR Doc. 97–6356 Filed 3–12–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0192]

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 collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by April 14,

1997.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Linda L. Brna, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–3158.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507), FDA has submitted the

following proposed collection of

information to OMB for review and

clearance:

Application to Market a New Drug,

Biologic, or an Antibiotic Drug for

Human Use; Use of Form FDA 356h

FDA is the Federal agency charged

with the responsibility for determining

that drugs, including antibiotic drugs,

and biologics are safe and effective.

Manufacturers of a drug, biologic, or an

antibiotic drug for human use must file

applications for FDA approval of the

product prior to introducing it into

interstate commerce. Statutory authority

for the collection of this information is

provided by sections 505(a), (b), and (j)

and 507 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355(a),

(b), and (j) and 357) and section 351 of

the Public Health Service Act (PHS Act)

(42 U.S.C. 262). All manufacturers of

new drugs and antibiotics for human

use regulated under the act must submit

an application for review and approval

to the Center for Drug Evaluation and

Research (CDER) or the Center for

Biologics Evaluation and Research

(CBER) prior to marketing a drug or

antibiotic in interstate commerce (21

CFR 314.50). All manufacturers of

generic drugs, including generic

antibiotic drugs for human use,

regulated under the act must submit an

abbreviated new drug application

(ANDA) to CDER or CBER or an

abbreviated antibiotic drug application

(AADA) to CDER for review and

approval prior to marketing a generic

drug in interstate commerce (21 CFR

314.94). Most manufacturers of

biological products regulated under the

PHS Act must submit an establishment

license application and a product

license application or a biologics license

application for review and approval to

CBER prior to marketing a biological

product in interstate commerce (21 CFR

601.2). Blood and blood components fall

within the category of biological

products. All establishments collecting

and/or preparing blood and blood

components for sale or distribution in

interstate commerce are subject to the

licensing application provisions of

section 351 of the PHS Act.

Manufacturers of a drug, biologic, or an

antibiotic drug for human use are

required to file supplemental

applications for all important changes to

applications previously approved prior

to implementing such changes (21 CFR

314.70, 314.71, 314.97, and 601.12).

Form FDA 356h has been revised for

CDER-regulated products to include

identification of different types of

supplemental applications. It has also

been modified to include a section for

establishment information pertaining to

CBER-regulated products and the CBER

licensing process.

The information provided by

manufacturers with the revised

application form is necessary for FDA to

carry out its mission of protecting the

public health and helping to ensure that

drugs, biologics, and antibiotics for

human use have been shown to be safe

and effective. Form FDA 356h was

developed initially as a checklist to

assist manufacturers in filing a drug

application and has been previously

used only by manufacturers of products

regulated under the act. The revised

form has been harmonized for use by

manufacturers of products regulated

under the act or under the PHS Act and

will be used by industry regulated by

both CDER and CBER. The harmonized

application form serves primarily as a

checklist for firms to gather and submit

to the agency studies and data that have

been completed. The checklist helps to

ensure that the application is complete

and contains all the necessary

information, so that delays due to lack

of information may be eliminated. The

form will also provide key information

to the agency for efficient handling and

distribution to the appropriate staff for

review. The revised form will replace a

number of different application forms

that are now used for these products

and is intended to help harmonize the

application process.

In the Federal Register of October 1,

1996 (61 FR 51285), the agency

requested comments on the proposed

collection of information using the

harmonized application form. FDA

received five responses to the docket, all

of which were generally supportive of

the harmonized application form. One

comment expressed concern that the

requirement to select a single

supplement type on the form would

result in an increased reporting burden.

The comment indicated that selection of

a single supplement type would require

the filing of multiple supplements in

order to respond to an agency

information request letter containing

several diverse issues. The comment

may have misunderstood the distinction

between a supplement to an approved

application and an amendment to a

pending application. A response to an

agency information request letter is an

amendment to a pending application, no

matter how many individual subjects

are addressed. This is clarified in the

instruction sheet for the form.

There were also a number of editorial

comments on the form itself. Some of

these have resulted in minor

modifications to the form. Other

editorial comments and requests for

clarification are addressed in the

instructions for use of the form.

FDA estimates the burden of this

collection of information as follows: