Submission for OMB Review; Comment Request, 41087 [E8-16197]
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Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Notices
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, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16183 Filed 7–16–08; 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: The OC5E–157 Child Support
Enforcement Annual Data Report.
OMB No.: 0970–0177.
Description: The information obtained
from this form will be used to: (1)
Report Child Support Enforcement
activities to the Congress as required by
law; (2) calculate incentive measures
performance and performance
indicators utilized in the program; and
(3) assist the Office of Child Support
Enforcement in monitoring and
evaluating State Child Support
programs.
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
OCSE–157 Child Support Annual Data Report ...............................................
54
1
7
378.
Estimated Total Annual Burden
Hours: 378
Additional Information: Copies of the
proposed collection may be obtained 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: ACE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail
address:infocollection@acf.hhs.gov.
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, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16197 Filed 7–16–08; 8:45 am]
mstockstill on PROD1PC66 with NOTICES
BILLING CODE 4184–01–M
VerDate Aug<31>2005
21:03 Jul 16, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0208]
(formerly Docket No. 2005D–0438)
Guidance for Industry: Safety, Efficacy,
and Pharmacokinetic Studies to
Support Marketing of Immune Globulin
Intravenous (Human) as Replacement
Therapy for Primary Humoral
Immunodeficiency; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Safety, Efficacy,
and Pharmacokinetic Studies to Support
Marketing of Immune Globulin
Intravenous (Human) as Replacement
Therapy for Primary Humoral
Immunodeficiency,’’ dated June 2008.
The guidance document provides
recommendations for the design of
clinical trials to assess the safety,
efficacy, and pharmacokinetics of
immune globulin intravenous (human)
(IGIV) products as replacement therapy
in primary humoral immunodeficiency.
The guidance announced in this notice
finalizes the draft guidance of the same
title dated November 2005.
DATES: Submit written or electronic
comments on agency guidances at any
time. Submit written requests for single
copies of the guidance to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 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 guidance
document.
ADDRESSES: Submit written comments
on the 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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
´
Denise Sanchez, 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 document entitled ‘‘Guidance for
Industry: Safety, Efficacy, and
Pharmacokinetic Studies to Support
Marketing of Immune Globulin
Intravenous (Human) as Replacement
Therapy for Primary Humoral
Immunodeficiency,’’ dated June 2008.
This guidance provides investigational
new drug application (IND) and
biologics license application (BLA)
sponsors with recommendations for the
design of clinical trials to assess the
safety, efficacy, and pharmacokinetics of
investigational IGIV products when
used as replacement therapy in primary
humoral immunodeficiency. This
E:\FR\FM\17JYN1.SGM
17JYN1
]]>Agencies
[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Page 41087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: The OC5E-157 Child Support Enforcement Annual Data Report.
OMB No.: 0970-0177.
Description: The information obtained from this form will be used
to: (1) Report Child Support Enforcement activities to the Congress as
required by law; (2) calculate incentive measures performance and
performance indicators utilized in the program; and (3) assist the
Office of Child Support Enforcement in monitoring and evaluating State
Child Support programs.
Respondents: State, Local or Tribal Government.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
OCSE-157 Child Support Annual Data Report... 54 1 7 378.
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 378
Additional Information: Copies of the proposed collection may be
obtained 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: ACE Reports Clearance
Officer. All requests should be identified by the title of the
information collection. E-mail address:infocollection@acf.hhs.gov.
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, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-16197 Filed 7-16-08; 8:45 am]
BILLING CODE 4184-01-M
