Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Establishment of a Public Docket, 70166-70167 [2012-28431]
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70166
Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices
preceding fiscal quarter and to estimate
program expenditures to be made in the
upcoming fiscal quarter. This form also
allows States and Tribes to report the
actual and estimated average monthly
number of children assisted in each of
the three IV–E entitlement grant
programs in the preceding and
upcoming fiscal quarters, respectively.
The Administration for Children and
Families provides Federal funding at the
rate of 50 percent for nearly all
allowable and legitimate administrative
costs of these programs and at other
funding rates for other specific
categories of costs as detailed in Federal
statute and regulations. The information
collected in this report is used by this
agency to calculate quarterly Federal
grant awards and to enable oversight of
the financial management of the
programs.
Respondents: States (including Puerto
Rico and the District of Columbia) and
Tribes* with approved title IV–E plans.
(*An estimated 10 Tribes will have
approved title IV–E plans within the
next 3-year period.)
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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Form CB–496: Title IV–E Programs Quarterly Financial Report ....................
Estimated Total Annual Burden
Hours: 4,960.
In compliance with the requirements
of Section 506(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 Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email 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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–28340 Filed 11–21–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1090]
Provisions of the Food and Drug
Administration Safety and Innovation
Act Related to Medical Gases;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is establishing a
public docket for information pertaining
to FDA’s implementation of the
provisions of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) related to medical gases.
This action is intended to ensure that
information submitted to FDA on the
implementation of the medical gas
provisions of FDASIA is available to all
interested persons in a timely fashion.
DATES: Submit electronic or written
comments by November 25, 2013.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522,
patrick.raulerson@fda.hhs.gov; or
Germaine Connolly, Center for
Veterinary Medicine, Food and Drug
SUMMARY:
PO 00000
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Number of
responses per
respondent
4
Average
burden hours
per response
20
Total burden
hours
4,960
Administration, 7500 Standish Pl.,
MPN2, Rockville, MD 20855, 240–276–
8331, germaine.connolly@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, President Obama
signed into law FDASIA (Pub. L. 112–
144, 126 Stat. 993). Title XI, Subtitle B,
section 1111 of FDASIA added new
sections 575, 576, and 577 to the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) regarding medical gases.
Among other things, these new sections
define the terms ‘‘designated medical
gas’’ and ‘‘medical gas’’ and establish
the process for the certification of a
medical gas as a designated medical gas.
(See sections 575(1) and (2) of the FD&C
Act.) The sections describe the process
for filing a request for certification and
describe the information that should be
included in the request for certification.
(See section 576(a) of the FD&C Act.)
Under section 576(a)(3) of the FD&C
Act, if a certification is granted for a
designated medical gas, the designated
medical gas will be deemed to have in
effect an approved new human drug
application under section 505 (21 U.S.C.
355) or an approved new animal drug
application under section 512 (21 U.S.C.
360b) of the FD&C Act for certain
specified indications and subject to all
applicable postapproval requirements.
Under section 576(a)(1) of the FD&C
Act, requests for certification may be
submitted to FDA beginning 180 days
after the enactment of FDASIA, or
January 5, 2013.
FDA is establishing a public docket
for information pertaining to FDA’s
implementation of these new medical
gas provisions. This action is intended
to ensure that information submitted to
FDA on the implementation of the
medical gas provisions of FDASIA is
available to all interested persons in a
timely fashion. The Compressed Gas
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Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices
Association and the Gases and Welding
Distributors Association voluntarily
submitted to the Agency its views on
implementation of the medical gas
provisions of FDASIA. FDA plans to
place these comments in the public
docket so they are readily available to
all interested members of the public.
FDA expects to place all additional
submissions containing
recommendations on how the Agency
should implement the medical gas
provisions of FDASIA in this docket,
and directs the public to submit all
comments related to these provisions to
this docket. This docket will be open for
comments for 1 year from the date of
publication of this notice. In addition,
as FDA implements the medical gas
provisions of FDASIA, FDA plans to
open other dockets. For example, we
plan to issue a separate Federal Register
notice in the future to provide the
public with an opportunity to submit
comments on section 1112 of FDASIA.
Section 1112(a)(1) of FDASIA provides
that not later than 18 months after the
date of the enactment of FDASIA, the
Secretary, after obtaining input from
medical gas manufacturers and any
other interested members of the public,
must determine whether any changes to
the Federal drug regulations are
necessary for medical gases.
II. Comments
Interested persons may submit either
written comments to the Division of
Dockets Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: November 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28431 Filed 11–21–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1120]
Draft Guidance for Industry on Vaginal
Microbicides: Development for the
Prevention of Human
Immunodeficiency Virus Infection;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Vaginal Microbicides:
Development for the Prevention of HIV
Infection.’’ The purpose of this guidance
is to assist sponsors in all phases of
development of vaginal microbicides for
the prevention of human
immunodeficiency virus (HIV)
infection. The guidance outlines the
types of nonclinical studies and clinical
trials recommended throughout the drug
development process to support
approval of vaginal microbicides.
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
either electronic or written comments
on the draft guidance by February 21,
2013.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Charu Mullick, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6365,
Silver Spring, MD 20993–0002, 301–
796–1500.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
PO 00000
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70167
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Vaginal Microbicides: Development for
the Prevention of HIV Infection.’’ This
guidance addresses nonclinical
development, early phases of clinical
development, phase 3 trial
considerations, and safety
considerations in vaginal microbicide
development, including safety
considerations in adolescent and
pregnant populations. The guidance
also provides some information on
approaches for developing combination
microbicide products such as drug-drug
combinations, drug-device
combinations containing a microbicide,
or combination products containing a
microbicide that are intended for
multiple indications. With the recent
approval of oral emtricitabine/tenofovir
for HIV pre-exposure prophylaxis
(PrEP), the effect of oral PrEP on
microbicide trial designs is an emerging
topic. The guidance discusses this issue;
however, it should be noted the
pertinent sections may be revised as
FDA takes into consideration evolving
opinions in the prevention field as well
as public comments on this topic.
This 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 developing vaginal microbicides for
preventing HIV transmission. 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.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information 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 312 have been approved under
OMB control number 0910–0014, and
the collections of information referred to
in the guidance for clinical trial
sponsors entitled ‘‘Establishment and
Operation of Clinical Trial Data
Monitoring Committees’’ have been
approved under OMB control number
0910–0581.
III. Comments
Interested persons may submit either
written comments regarding the draft
guidance to the Division of Dockets
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]]>Agencies
[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70166-70167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28431]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1090]
Provisions of the Food and Drug Administration Safety and
Innovation Act Related to Medical Gases; Establishment of a Public
Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket for information pertaining to FDA's implementation of the
provisions of the Food and Drug Administration Safety and Innovation
Act (FDASIA) related to medical gases. This action is intended to
ensure that information submitted to FDA on the implementation of the
medical gas provisions of FDASIA is available to all interested persons
in a timely fashion.
DATES: Submit electronic or written comments by November 25, 2013.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522, patrick.raulerson@fda.hhs.gov; or Germaine Connolly, Center
for Veterinary Medicine, Food and Drug Administration, 7500 Standish
Pl., MPN2, Rockville, MD 20855, 240-276-8331,
germaine.connolly@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, President Obama signed into law FDASIA (Pub. L.
112-144, 126 Stat. 993). Title XI, Subtitle B, section 1111 of FDASIA
added new sections 575, 576, and 577 to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) regarding medical gases. Among other
things, these new sections define the terms ``designated medical gas''
and ``medical gas'' and establish the process for the certification of
a medical gas as a designated medical gas. (See sections 575(1) and (2)
of the FD&C Act.) The sections describe the process for filing a
request for certification and describe the information that should be
included in the request for certification. (See section 576(a) of the
FD&C Act.) Under section 576(a)(3) of the FD&C Act, if a certification
is granted for a designated medical gas, the designated medical gas
will be deemed to have in effect an approved new human drug application
under section 505 (21 U.S.C. 355) or an approved new animal drug
application under section 512 (21 U.S.C. 360b) of the FD&C Act for
certain specified indications and subject to all applicable
postapproval requirements. Under section 576(a)(1) of the FD&C Act,
requests for certification may be submitted to FDA beginning 180 days
after the enactment of FDASIA, or January 5, 2013.
FDA is establishing a public docket for information pertaining to
FDA's implementation of these new medical gas provisions. This action
is intended to ensure that information submitted to FDA on the
implementation of the medical gas provisions of FDASIA is available to
all interested persons in a timely fashion. The Compressed Gas
[[Page 70167]]
Association and the Gases and Welding Distributors Association
voluntarily submitted to the Agency its views on implementation of the
medical gas provisions of FDASIA. FDA plans to place these comments in
the public docket so they are readily available to all interested
members of the public. FDA expects to place all additional submissions
containing recommendations on how the Agency should implement the
medical gas provisions of FDASIA in this docket, and directs the public
to submit all comments related to these provisions to this docket. This
docket will be open for comments for 1 year from the date of
publication of this notice. In addition, as FDA implements the medical
gas provisions of FDASIA, FDA plans to open other dockets. For example,
we plan to issue a separate Federal Register notice in the future to
provide the public with an opportunity to submit comments on section
1112 of FDASIA. Section 1112(a)(1) of FDASIA provides that not later
than 18 months after the date of the enactment of FDASIA, the
Secretary, after obtaining input from medical gas manufacturers and any
other interested members of the public, must determine whether any
changes to the Federal drug regulations are necessary for medical
gases.
II. Comments
Interested persons may submit either written comments to the
Division of Dockets Management (see ADDRESSES) or electronic comments
to https://www.regulations.gov. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: November 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28431 Filed 11-21-12; 8:45 am]
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