Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products; Availability, 19094-19095 [E9-9519]
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Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices
Part III of the proposed order
prohibits Respondent from making
misrepresentations in advertising for
any morning food or snack food about
the existence, contents, validity, results,
conclusions, or interpretations of any
test, study or research.
Part IV of the proposed order states
that the order does not prohibit
Respondent from making
representations for any product that are
specifically permitted in labeling for
that product by regulations issues by the
FDA under the Nutrition Labeling and
Education Act of 1990.
Parts V through VIII of the proposed
order require Respondent to keep copies
of relevant advertisements and materials
substantiating claims made in the
advertisements; to provide copies of the
order to certain of their personnel; to
notify the Commission of changes in
corporate structure that might affect
compliance obligations under the order;
and to file compliance reports with the
Commission. Part IX provides that the
order will terminate after twenty (20)
years, with certain exceptions.
The purpose of this analysis is to
facilitate public comment on the
proposed order, and it is not intended
to constitute an official interpretation of
the agreement and proposed order or to
modify in any way their terms.
By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. E9–9484 Filed 4–24–09: 8:45 am]
BILLING CODE 6750–01–S
GENERAL SERVICES
ADMINISTRATION
Public Buildings Service; Information
Collection; GSA Form 3453,
Application/Permit for Use of Space in
Public Buildings and Grounds
Public Buildings Service, GSA.
Notice of request for comments
regarding a renewal to an existing OMB
clearance.
AGENCY:
pwalker on PROD1PC71 with NOTICES
ACTION:
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the General Services
Administration will be submitting to the
Office of Management and Budget
(OMB) a request to review and approve
a renewal of a currently approved
information collection requirement
regarding GSA Form 3453, Application/
Permit for Use of Space in Public
Buildings and Grounds. The clearance
currently expires on April 30, 2009.
17:28 Apr 24, 2009
DATES: Submit comments on or before:
June 26, 2009.
FOR FURTHER INFORMATION CONTACT:
Frank Giblin, Public Buildings Service,
at telephone (202) 501–1856, or via
e-mail to frank.giblin@gsa.gov.
Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden, to the Regulatory Secretariat
(VPR), General Services Administration,
Room 4041, 1800 F Street, NW.,
Washington, DC 20405. Please cite OMB
Control No. 3090–0044, GSA Form
3453, Application/Permit for Use of
Space in Public Buildings and Grounds,
in all correspondence.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
A. Purpose
The general public uses GSA Form
3453, Application/Permit for Use of
Space in Public Buildings and Grounds,
to request the use of public space in
Federal buildings and on Federal
grounds for cultural, educational, or
recreational activities. A copy, sample,
or description of any material or item
proposed for distribution or display
must also accompany this request.
B. Annual Reporting Burden
[OMB Control No. 3090–0044]
VerDate Nov<24>2008
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected.
Jkt 217001
Respondents: 8,000.
Responses per Respondent: 1.
Hours per Response: 0.05.
Total Burden Hours: 400.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 3090–0044,
GSA Form 3453, Application/Permit for
Use of Space in Public Buildings and
Grounds, in all correspondence.
Dated: April 21, 2009.
Philip E. Klokis,
Acting Chief Information Officer.
[FR Doc. E9–9490 Filed 4–24–09; 8:45 am]
BILLING CODE 6820–YT–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0179]
Draft Guidance for Industry and Food
and Drug Administration Staff:
Technical Considerations for Pen, Jet,
and Related Injectors Intended for Use
With Drugs and Biological Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document entitled ‘‘Technical
Considerations for Pen, Jet, and Related
Injectors Intended for Use with Drugs
and Biological Products.’’ The draft
guidance document provides technical
and scientific information for sponsors
to consider in developing information to
support a marketing application for a
pen, jet, or related injector device
intended for use with drugs or
biological products. The marketing
application would typically be a
premarket notification submission
(510(k)) or a premarket approval (PMA)
application for the injector alone. For a
combination product that includes the
injector, the marketing application
would typically be a new drug
application (NDA) or a biological
licensing application (BLA).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 27, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Combination Products, 15800
Crabbs Branch Way, Rockville, MD
20855. 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 the Office of Combination
Products at 301–427–1934 or by e-mail
to combination@fda.gov. 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.regulations.gov.
E:\FR\FM\27APN1.SGM
27APN1
Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices
FOR FURTHER INFORMATION CONTACT:
Patricia Y. Love, Office of Combination
Products (HFG–3), Food and Drug
Administration, 15800 Crabbs Branch
Way, Rockville, MD 20855, 301–427–
1934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance document entitled
‘‘Technical Considerations for Pen, Jet,
and Related Injectors Intended for Use
with Drugs and Biological Products.’’
FDA is providing this draft guidance
document to assist industry in
developing technical and scientific
information to support a marketing
application for a pen, jet, or related
injector device. The marketing
application would typically be a 510(k)
or a PMA application for the injector
alone. For a combination product that
includes the injector, the marketing
application would typically be an NDA
or a BLA. For purposes of this guidance,
the term ‘‘injector’’ includes, but is not
limited to, jet injectors, pen injectors,
piston syringes, needle-free injectors,
mechanically operated injectors, and
injectors with computerized or
electronic elements.
pwalker on PROD1PC71 with NOTICES
II. Significance of Guidance
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 the agency’s current thinking
on ‘‘Technical Considerations for Pen,
Jet, and Related Injectors Intended for
Use with Drugs and Biological
Products.’’ 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
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
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 807 have
been approved under OMB control
number 0910–0120. The collections of
information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information 21 CFR part 601 have been
approved under OMB control number
0910–0338.
VerDate Nov<24>2008
15:55 Apr 24, 2009
Jkt 217001
IV. 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.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/oc/combination/ or
https://www.regulations.gov.
Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9519 Filed 4–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Healthy Start Program
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: General notice.
BACKGROUND: This notice
supplements the 2008 HRSA
announcement (HRSA 09–130 and 09–
131) of the availability of fiscal year
(FY) 2009 funding for new and
competing continuation applications for
Healthy Start. Healthy Start, authorized
under Section 330H of the Public Health
Service Act, strengthens communities to
effectively address the causes of infant
mortality, low birth weight and other
poor perinatal outcomes for women and
infants. Recently, new guidance became
available with regard to funding FY
2009 Healthy Start programs.
SUMMARY: Following the Senate
Appropriations Committee’s
recommendation, the Health Resources
and Services Administration (HRSA)
will give funding preference during the
FY 2009 competition to current and
former Healthy Start grantees with
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19095
expiring or recently expired project
periods.
This new guidance continues
guidance from Congress that began in
FY 2002. During the FY 2001 Healthy
Start Initiative: Eliminating Disparities
in Perinatal Health Open Competition,
several grantees were approved but
unfunded. Subsequently, Congress
noted that the phasing out of these
grants would cause a major disruption
in services for pregnant women and
infants in communities with high infant
mortality and poor perinatal outcomes.
For FY 2002, Congress, under The
Consolidated Appropriations Act of
2002 (Pub. L. 107–116), Departments of
Labor, Health and Human Services, and
Education, and Related Agencies
Appropriations Act, 2002, allocated
additional funding for these grants but
stipulated that these new funds were to
be used to ‘‘give preference to current
and former grantees with expiring or
recently expired project periods,
including grantees that did not receive
funding but whose grant applications
were approved but not funded during
fiscal year 2001.’’ HRSA honored this
request and funded the remaining
approved unfunded grantee applicants
in February 2002.
This preference language has
continued in each Healthy Start
competition since 2002. With the 2005
Healthy Start competition, Congress,
through The Consolidated
Appropriations Act (Pub. L. 108–447,
HR 108–792), once again gave
‘‘preference to current and former
grantees with expiring or recently
expired project periods.’’ In 2006, the
Conference report HR 109–200,
accompanying the Departments of
Labor, Health and Human Services,
Education, and Related Agencies
Appropriation Act, 2006, (Pub. L. 109–
149, HR 109–300) continued the
preference language. This year’s FY
2009 Senate Appropriations Committee
report states that ‘‘The healthy start
initiative was developed to respond to
persistently high rates of infant
mortality in this Nation. The initiative
was expanded in fiscal year 1994 by a
special projects program, which
supported an additional seven urban
and rural communities to implement
infant mortality reduction strategies and
interventions. The Children’s Health
Act of 2000 fully authorized this
initiative as an independent program.
The Committee urges HRSA to give
preference to current and former
grantees with expiring or recently
expired project periods.’’ (S. Rept. 110–
410)
E:\FR\FM\27APN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19094-19095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9519]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0179]
Draft Guidance for Industry and Food and Drug Administration
Staff: Technical Considerations for Pen, Jet, and Related Injectors
Intended for Use With Drugs and Biological Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Technical
Considerations for Pen, Jet, and Related Injectors Intended for Use
with Drugs and Biological Products.'' The draft guidance document
provides technical and scientific information for sponsors to consider
in developing information to support a marketing application for a pen,
jet, or related injector device intended for use with drugs or
biological products. The marketing application would typically be a
premarket notification submission (510(k)) or a premarket approval
(PMA) application for the injector alone. For a combination product
that includes the injector, the marketing application would typically
be a new drug application (NDA) or a biological licensing application
(BLA).
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 27, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Combination Products, 15800 Crabbs Branch
Way, Rockville, MD 20855. 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 the Office of Combination Products
at 301-427-1934 or by e-mail to combination@fda.gov. 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.regulations.gov.
[[Page 19095]]
FOR FURTHER INFORMATION CONTACT: Patricia Y. Love, Office of
Combination Products (HFG-3), Food and Drug Administration, 15800
Crabbs Branch Way, Rockville, MD 20855, 301-427-1934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance document
entitled ``Technical Considerations for Pen, Jet, and Related Injectors
Intended for Use with Drugs and Biological Products.'' FDA is providing
this draft guidance document to assist industry in developing technical
and scientific information to support a marketing application for a
pen, jet, or related injector device. The marketing application would
typically be a 510(k) or a PMA application for the injector alone. For
a combination product that includes the injector, the marketing
application would typically be an NDA or a BLA. For purposes of this
guidance, the term ``injector'' includes, but is not limited to, jet
injectors, pen injectors, piston syringes, needle-free injectors,
mechanically operated injectors, and injectors with computerized or
electronic elements.
II. Significance of Guidance
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 the agency's current thinking on ``Technical
Considerations for Pen, Jet, and Related Injectors Intended for Use
with Drugs and Biological Products.'' 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 requirements of the applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
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 807 have been approved under
OMB control number 0910-0120. The collections of information in 21 CFR
part 814 have been approved under OMB control number 0910-0231. The
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001. The collections of information 21 CFR
part 601 have been approved under OMB control number 0910-0338.
IV. 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.
V. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/oc/combination/ or https://www.regulations.gov.
Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9519 Filed 4-24-09; 8:45 am]
BILLING CODE 4160-01-S
