2984 Federal Register / Vol. 63, No. 12 / Tuesday, January 20, 1998 / Notices

and elevated blood pressure are two

problems that disproportionately affect

minority groups. Establishing a link

between blood pressure and lead

exposure, especially utilizing two new

biomarkers of lead exposure, bone lead

and serum lead, can provide a new tool

for dealing with elevated blood pressure

nationwide.

This request is for a 3-year extension.

Two previously approved

questionnaires will continue to be used

to collect socioeconomic data, and data

pertaining to risk factors for elevated

blood pressure and lead exposure. A

new questionnaire assessing social

stress (Scale of Chronic Social Role

Stressors) and a 16 item, four response

choice scale will be added to better

control for social stress factors affecting

blood pressure. There is no cost to

respondents.

Type of respondent

No. of respondents per

year

No. of responses/respondentAvg. burden per

response (in

hrs)

Total burden

(in hrs)

Screening Questionnaire ................................................................................ 880 1 .5 440

Social Role Stressors ..................................................................................... 880 1 .08 70

Risk Questionnaire ......................................................................................... 330 2 .75 495

Total ......................................................................................................... ........................ ........................ .......................... 1005

Dated: January 13, 1998.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–1206 Filed 1–16–98; 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: Community-Based Family

Resource and Support Grants.

OMB No.: 0970–0155.

Description: Application information

is required when a State wishes to

receive a Community-Based Family

Resource and Support (CBFRS) grant

award. This Program Instruction

contains information collection

requirements found in Pub. L. 104–235

at Sections 202(1)(A); 202(b)(1)(B); 205;

and 207. The information being

collected is required by statute to be

submitted pursuant to receiving a grant

award. The information submitted will

be used by the agency to ensure

compliance with the statute, complete

the calculation of the grant award

entitlement, provide training and

technical assistance to the grantee, and

evaluate State efforts in the prevention

of child abuse and neglect.

Respondents: State, Local or Tribal

Government.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses per

respondent

Average

burden hours

per response

Total burden

hours

Application ........................................................................................................ 57 1 40 2,280

Annual Report ................................................................................................... 57 1 40 1,368

Estimated Total Annual Burden

Hours: 3,648.

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,

Division of Information Resource

Management 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: January 13, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–1183 Filed 1–16–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Emergency TANF Data Report

(ACF–198).

OMB No.: 0970–0164.

Description: This information is being

collected to meet the statutory

requirements of section 411 of the

Social Security Act and section 116 of
Federal Register / Vol. 63, No. 12 / Tuesday, January 20, 1998 / Notices 2985

1The term unrelated allogeneic use means the

implantation, infusion, or transfer of a human

cellular or tissue-based product from one person to

another who is not a parent, sibling, or a child of

the donor.

2The term minimally manipulated means

processing of cells and nonstructural tissues that

does not alter the biological characteristics and

thus, potentially, the function or integrity of the

cells or tissues.

the Personal Responsibility and Work

Opportunity Reconciliation Act of 1996.

It consists of disaggregated and

aggregated demographic and program

information that will be used to

determine participation rates and other

statutorily required indicators for the

Temporary Assistance for Needy

Families (TANF) program. OMB

previously approved this data collection

under emergency procedures through

January 31, 1998. We are now

requesting an extension through

September 30, 1998, in order to

maintain the continuity of data

collection pending OMB approval of the

data collection instruments published in

the NPRM dated November 20, 1997.

Respondents: States and Territories.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Emergency TANF Data Report ........................................................................ 54 4 451 97,416

Estimated Total Annual Burden

Hours: 97,416.

Additional Information

Copies of the proposed collection may

be obtained by writing to The

Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer.

OMB Comment

OMB is required to make a decision

concerning the collection of information

between 30 and 60 days after

publication of this document in the

Federal Register. Therefore, a comment

is best assured of having its full effect

if OMB receives it within 30 days of

publication. Written comments and

recommendations for the proposed

information collection should be sent

directly to the following: Office of

Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Laura Oliven.

Dated: January 7, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–1251 Filed 1–16–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0497]

Request for Proposed Standards for

Unrelated Allogeneic Peripheral and

Placental/Umbilical Cord Blood

Hematopoietic Stem/Progenitor Cell

Products; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

submission of comments proposing

product standards intended to ensure

the safety and effectiveness of

minimally manipulated hematopoietic

stem/progenitor cells derived from

peripheral and cord blood for unrelated

allogeneic use.1 The comments should

include supporting clinical and

nonclinical laboratory data and other

relevant information. This information

will aid FDA in developing product

standards for hematopoietic stem/

progenitor cell products intended for

allogeneic use in recipients unrelated to

the donor (hereinafter referred to as

unrelated allogeneic), including

manufacturing controls and product

specifications. FDA is also announcing

its intention to phase-in implementation

of investigational new drug application

(IND) and license application

requirements for minimally

manipulated2 unrelated allogeneic

hematopoietic stem/progenitor cell

products 3 years after the date of

issuance of this notice to permit the

development of licensing standards for

those products where possible. This

action is taken in response to the

agency’s ‘‘Proposed Approach to

Regulation of Cellular and Tissue-based

Products,’’ which fullfills the objectives

of the administration’s ‘‘Reinventing the

Regulation of Human Tissue’’ initiated

to streamline regulatory requirements to

ease the burden on regulated industry,

while providing adequate protection to

the public health.

DATES: Submit requested standards and

supporting clinical and nonclinical

laboratory data by January 20, 2000.

ADDRESSES: Submit proposed product

standards and supporting data to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

A. Use of Peripheral and Cord Blood

Stem/Progenitor Cells for Hematopoietic

Reconstitution

The field of hematologic

transplantation has changed

substantially during the last two

decades. Improved understanding of the

diverse aspects of human hematologic

precursors has facilitated their

experimental manipulation. Our

knowledge of their localization in

humans during both fetal and postnatal

development, growth regulation,

differentiation, homing, and of

phenotypic and functional

characteristics has facilitated the

development of new methods of

transplantation. Traditional bone

marrow transplantation, involving the

extraction of bone marrow by aspiration

from bone cavities with further

processing by density centrifugation, is

increasingly being supplanted by novel

approaches that include use of

hematopoietic stem/progenitor cells and

biotechnologic procedures to purify and

expand hematopoietic stem/progenitor

cells. Human cord blood, which is

enriched with pluripotent

hematopoietic stem/progenitor cells,

and peripheral blood, which can be

enriched in hematopoietic stem/

progenitor cells by a variety of