Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Notices 1999 

than 40 discretionary grant programs. 

The proposed information collection 

form would be a uniform discretionary 

application form eligible for use by 

grant applications to submit project 

information in response to ACF program 

announcements. ACF would use this 

information, along with other OMBapproved information collections, to 

evaluate and rank applicants and 

protect the integrity of the grantee 

selection process. All ACF discretionary 

grant programs would be eligible but not 

required to use this application form. 

The application consists of general 

information and instructions; the 

Standard Form 424 series that requests 

basic information, budget information, 

budget information and assurances; the 

Project Description requesting the 

applicant to describe how these 

objectives will be achieved; along with 

assurances and certifications. Guidance 

for the content of information requested 

in the Project Description is found in 

OMB Circulars A–102 and A–110. 

Respondents: Applicants for ACF 

Discretionary Grant Programs. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

UPD ................................................................................................................. 11,960 1 40 478,400 

Estimated Total Annual Burden 

Hours: 478,400. 

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 Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. 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 11, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–127 Filed 1–16–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0514] 

Draft Guidance for Industry: Minimally 

Manipulated, Unrelated, Allogeneic 

Placental/Umbilical Cord Blood 

Intended for Hematopoietic 

Reconstitution in Patients with 

Hematological Malignancies; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Minimally 

Manipulated, Unrelated, Allogeneic 

Placental/Umbilical Cord Blood 

Intended for Hematopoietic 

Reconstitution in Patients with 

Hematological Malignancies’’ dated 

December 2006. The draft guidance 

document provides recommendations 

that would allow the manufacturer, 

generally a cord blood bank, to apply for 

licensure of minimally manipulated, 

unrelated, allogeneic placental/ 

umbilical cord blood, for specified 

indications. The document also contains 

information about the manufacture of 

minimally manipulated, unrelated, 

allogeneic placental/umbilical cord 

blood and how to comply with 

applicable regulatory requirements. 

DATES: Submit written or electronic 

comments on the draft guidance by 

April 17, 2007 to ensure their adequate 

consideration in preparation of the final 

guidance. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1–

800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen E. Swisher, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Minimally Manipulated, 

Unrelated, Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution in 

Patients with Hematological 

Malignancies’’ dated December 2006. 

The draft guidance document provides 

recommendations that would allow the 

manufacturer, generally a cord blood 

bank, to apply for licensure of 

minimally manipulated, unrelated, 

allogeneic placental/umbilical cord 

blood, for specified indications. The 

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2000 Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Notices 

guidance document provides 

recommendations for the submission of 

a biologics license application for 

placental/umbilical cord blood products 

that are: (1) Manipulated minimally; (2) 

used for hematopoietic reconstitution in 

patients with hematological 

malignancies; and (3) used in recipients 

unrelated to the donor. The document 

also contains information about the 

manufacture of minimally manipulated, 

unrelated, allogeneic placental/ 

umbilical cord blood and how to 

comply with applicable regulatory 

requirements. For the manufacture of 

peripheral blood or cord hematopoietic 

stem/progenitor cells other than those 

described, the manufacturer may need 

to submit an investigational new drug 

application or other premarketing 

application for that product. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 201 have 

been approved under OMB Control No. 

0910–0572; 21 CFR part 211 have been 

approved under OMB Control No. 0910–

0139; 21 CFR part 600 have been 

approved under OMB Control No. 0910–

0308; 21 CFR parts 601, 610, and FDA 

Form 356(h) have been approved under 

OMB Control No. 0910–0338; 21 CFR 

part 1271 have been approved under 

OMB Control Nos. 0910–0559, 0910–

0469, and 0910–0543; and FDA Form 

3500A has been approved under OMB 

Control No. 0910–0291. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: January 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–549 Filed 1–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5117–N–02] 

Notice of Submission of Proposed 

Information Collection to OMB; 

Multifamily Housing Service 

Coordinator Program 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

Housing project owners/managers 

apply for grants under the Housing 

Service Coordinator Program. The 

requested information will assist HUD 

in evaluating grant applicants and to 

determine how well grant funds meet 

stated program goals and how well the 

public was served. 

DATES: Comments Due Date: February 

16, 2007. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

approval Number (2502–0447) and 

should be sent to: HUD Desk Officer, 

Office of Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Deitzer, Departmental Reports 

Management Officer, QDAM, 

Department of Housing and Urban 

Development, 451 Seventh Street, SW., 

Washington, DC 20410; e-mail 

Lillian_L._Deitzer@HUD.gov or 

telephone (202) 708–2374. This is not a 

toll-free number. Copies of available 

documents submitted to OMB may be 

obtained from Ms. Deitzer or from 

HUD’s Web site at http:// 

hlannwp031.hud.gov/po/i/icbts/ 

collectionsearch.cfm. 

SUPPLEMENTARY INFORMATION: This 

notice informs the public that the 

Department of Housing and Urban 

Development has submitted to OMB a 

request for approval of the information 

collection described below. This notice 

is soliciting comments from members of 

the public and affecting agencies 

concerning the proposed collection of 

information to: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) Minimize the 

burden of the collection of information 

on those who are to respond; including 

through the use of appropriate 

automated collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

This notice also lists the following 

information: 

Title of Proposal: Multifamily 

Housing Service Coordinator Program. 

OMB Approval Number: 2502–0447. 

Form Numbers: SF–424, SF–424–

Supp, SF–LLL, HUD–2880, HUD–2993, 

HUD–2994–A, HUD–96010, HUD–

92456, HUD–50080–SCMF–HUD–

91186, SF–269–A, and HUD–91186–A. 

Description of the Need for the 

Information and Its Proposed Use: 

Housing project owners/manages apply 

for grants under the Housing Service 

Coordinator Program. The requested 

information will assist HUD in 

evaluating grant applicants and to 

determine how well grant funds meet 

stated program goals and how well the 

public was served. 

Frequency of Submission: Quarterly, 

Semi-annually, Annually. 

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