Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies; Availability, 1999-2000 [E7-549]
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Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Notices
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
1999
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
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
UPD .................................................................................................................
mstockstill on PROD1PC61 with NOTICES
Instrument
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
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13:58 Jan 16, 2007
Jkt 211001
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.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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 https://
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:
ADDRESSES:
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
E:\FR\FM\17JAN1.SGM
17JAN1
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.
mstockstill on PROD1PC61 with NOTICES
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
VerDate Aug<31>2005
13:58 Jan 16, 2007
Jkt 211001
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
https://www.fda.gov/cber/guidelines.htm
or https://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
Office of the Chief Information
Officer, HUD.
ACTION: Notice.
AGENCY:
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
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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 https://
hlannwp031.hud.gov/po/i/icbts/
collectionsearch.cfm.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17JAN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 10 (Wednesday, January 17, 2007)]
[Notices]
[Pages 1999-2000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-549]
-----------------------------------------------------------------------
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 https://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
[[Page 2000]]
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 https://www.fda.gov/cber/guidelines.htm or https://
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
