Draft Guidance for Industry on User Fee Waivers for Fixed Dose Combination Products and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability, 20145-20146 [05-7729]
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Federal Register / Vol. 70, No. 73 / Monday, April 18, 2005 / Notices
and financial reports are due 90 days
after the close of the project period.
VII. Agency Contacts
Program Office Contact: Catherine
Beck, Administration for Children and
Families, Office of Community Services’
Operations Center, 1515 Wilson
Boulevard, Suite 100, Arlington, VA
22209, Phone: 1–800–281–9519, Fax:
703–528–0716, E-mail:
OCS@lcgnet.com.
Grants Management Office Contact:
Barbara Ziegler-Johnson, Administration
for Children and Families, Office of
Grants Management, Division of
Discretionary Grants, 370 L’Enfant
Promenade, SW., Aerospace Building,
Washington, DC 20447–0002, Phone: 1–
800–281–9519, Fax: 703–528–0716, Email: OCS@lcgnet.com.
VIII. Other Information
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: www.Grants.gov.
Applicants will also be able to find the
complete text of all ACF grant
announcements on the ACF Web site
located at: https://www.acf.hhs.gov/
grants/.
The FY 2006 President’s budget does
not include or propose funding for the
Community Food and Nutrition
Program. Future funding is based on the
availability of Federal funds.
Direct federal grants, subaward funds,
or contracts under this community Food
and Nutrition Program shall not be used
to support inherently religious activities
such as religious instruction, worship,
or proselytization. Therefore,
organizations must take steps to
separate, in time or location, their
inherently religious activities from the
services funded under this Program.
Regulations pertaining to the
prohibition of Federal funds for
inherently religious activities can be
found on the HHS Web site at https://
www.os.HHS.gov/fbci/waisgate21.pdf.
Additional Information about this
program and its purpose can be located
on the following Web site: https://
www.acf.hhs.gov/programs/ocs.
Please reference Section IV.3 for
details about acknowledgement of
received applications.
VerDate jul<14>2003
16:08 Apr 15, 2005
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Dated: April 7, 2005.
Josephine B. Robinson,
Director, Office of Community Services.
[FR Doc. 05–7461 Filed 4–15–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4184–01–P
[Docket No. 2005D–0091]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005F–0138]
Kareem I. Batarseh; Filing of Food
Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Draft Guidance for Industry on User
Fee Waivers for Fixed Dose
Combination Products and CoPackaged Human Immunodeficiency
Virus Drugs for the President’s
Emergency Plan for Acquired
Immunodeficiency Syndrome Relief;
Availability
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that Kareem I. Batarseh has filed a
petition proposing that the food additive
regulations be amended to provide for
the safe use of a mixture of hydrogen
peroxide, silver nitrate, phosphoric
acid, tartaric acid, glutamic acid, and
sodium tripolyphosphate as an
antimicrobial agent in bottled drinking
water.
FOR FURTHER INFORMATION CONTACT:
Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1278.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 409 (b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 5A4759) has been filed by
Kareem I. Batarseh, P.O. Box 8, College
Park, MD 20741–0008. The petition
proposes to amend the food additive
regulations in part 172 Food Additives
Permitted For Direct Addition To Food
For Human Consumption (21 CFR part
172) to provide for the safe use of a
mixture of hydrogen peroxide, silver
nitrate, phosphoric acid, tartaric acid,
glutamic acid, and sodium
tripolyphosphate as an antimicrobial
agent in bottled drinking water.
The agency has determined under 21
CFR 25.32(k) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Dated: April 1, 2005.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 05–7727 Filed 4–15–05; 8:45 am]
BILLING CODE 4160–01–S
Frm 00045
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Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
PO 00000
Food and Drug Administration
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘User Fee Waivers for
FDC and Co-Packaged HIV Drugs for
PEPFAR.’’ This draft guidance describes
the circumstances under which certain
applications for fixed dose combination
(FDC) and copackaged versions of
previously approved antiretroviral
therapies for the treatment of human
immunodeficiency virus (HIV) under
the President’s Emergency Plan for
Acquired Immunodeficiency Syndrome
Relief (PEPFAR) will not be assessed
user fees. The draft guidance also
describes circumstances under which
some of the applications that will be
assessed fees may be eligible for a
public health or a barrier-to-innovation
waiver.
DATES: Submit written or electronic
comments on the draft guidance by June
17, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
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. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Michael Jones, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
E:\FR\FM\18APN1.SGM
18APN1
20146
Federal Register / Vol. 70, No. 73 / Monday, April 18, 2005 / Notices
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘User Fee Waivers for FDC and CoPackaged HIV Drugs for PEPFAR.’’ The
draft guidance describes the
circumstances under which certain
applications for FDC and copackaged
versions of previously approved
antiretroviral therapies for the treatment
of HIV under PEPFAR will not be
assessed user fees. The draft guidance
also describes circumstances under
which some of the applications that will
be assessed fees may be eligible for a
public health or a barrier-to-innovation
waiver.
As part of PEPFAR, FDA issued in
May 2004 a draft guidance entitled
‘‘Fixed Dose Combination and CoPackaged Drug Products for the
Treatment of HIV’’ (Fixed Dose
Guidance) (69 FR 28931, May 19, 2004).
The Fixed Dose Guidance described
some scenarios for approval of FDC or
copackaged products for the treatment
of HIV, provided examples of drug
combinations considered acceptable for
FDC/copackaging, and examples of
those not considered acceptable for
FDC/copackaging. The draft guidance
also explained that the Federal Food,
Drug, and Cosmetic Act provides for
certain circumstances in which FDA can
grant sponsors a waiver or reduction in
fees. The draft guidance also stated that
the agency was evaluating the
circumstances under which it may grant
user fee waivers or reductions for
sponsors developing FDC and
copackaged versions of previously
approved antiretroviral therapies for the
treatment of HIV. Since issuance of the
Fixed Dose Guidance, several potential
applicants have asked that we clarify
whether sponsors submitting drug
applications under the Fixed Dose
Guidance and under the PEPFAR
program will be required to pay user
fees under the Prescription Drug User
Fee Act (PDUFA) and if so, whether
they would be eligible for a waiver of
those fees. As explained in this draft
guidance, in some of the scenarios
described in the Fixed Dose Guidance,
a sponsor could qualify for fee
exemptions or would only be assessed
a half-fee either because the sponsor is
using an active ingredient that has
already been approved or the
application does not require clinical
data for approval. A sponsor of an
application that would be assessed
either a full- or a half-fee may also
qualify for a waiver of the application
fee under several provisions of PDUFA.
We expect that most of the
applications, products, and
establishments for FDC and copackaged
HIV therapies proposed for use in the
PEPFAR program will either not be
assessed fees in the first instance or will
qualify for a waiver under the special
circumstances part of the barrier-toinnovation user fee waiver.
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 waivers of user fees for FDC and
copackaged products for the treatment
of HIV under PEPFAR. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Two
copies of mailed comments are to be
submitted, except that individuals may
submit one copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7729 Filed 4–15–05; 8:45 am]
BILLING CODE 4160–01–S
Number of
respondents
Form
Application .......................................................................................................
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources And Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1129.
Comments are invited 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)
ways to enhance 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.
Proposed Project: Application for
Certification and Recertification as a
Federally Qualified Health Center
(FQHC) Look-Alike (OMB No. 0915–
0142): Revision
The Health Resources and Services
Administration (HRSA) proposes to
revise the application guide used by
organizations applying for certification
or recertificaion as a Federally Qualified
Health Center (FQHC) Look-Alike for
purposes of cost-based reimbursement
under the Medicaid and Medicare
programs. The guide will be revised to
reflect legislative, policy, and technical
changes since August 2003, the issuance
date of the last guidance. The estimated
burden is as follows:
Responses
per
respondent
40
E:\FR\FM\18APN1.SGM
Hours per
response
1
18APN1
100
Total burden
hours
4,000
Agencies
[Federal Register Volume 70, Number 73 (Monday, April 18, 2005)]
[Notices]
[Pages 20145-20146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0091]
Draft Guidance for Industry on User Fee Waivers for Fixed Dose
Combination Products and Co-Packaged Human Immunodeficiency Virus Drugs
for the President's Emergency Plan for Acquired Immunodeficiency
Syndrome Relief; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``User Fee
Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This draft
guidance describes the circumstances under which certain applications
for fixed dose combination (FDC) and copackaged versions of previously
approved antiretroviral therapies for the treatment of human
immunodeficiency virus (HIV) under the President's Emergency Plan for
Acquired Immunodeficiency Syndrome Relief (PEPFAR) will not be assessed
user fees. The draft guidance also describes circumstances under which
some of the applications that will be assessed fees may be eligible for
a public health or a barrier-to-innovation waiver.
DATES: Submit written or electronic comments on the draft guidance by
June 17, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. 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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers
[[Page 20146]]
Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for
PEPFAR.'' The draft guidance describes the circumstances under which
certain applications for FDC and copackaged versions of previously
approved antiretroviral therapies for the treatment of HIV under PEPFAR
will not be assessed user fees. The draft guidance also describes
circumstances under which some of the applications that will be
assessed fees may be eligible for a public health or a barrier-to-
innovation waiver.
As part of PEPFAR, FDA issued in May 2004 a draft guidance entitled
``Fixed Dose Combination and Co-Packaged Drug Products for the
Treatment of HIV'' (Fixed Dose Guidance) (69 FR 28931, May 19, 2004).
The Fixed Dose Guidance described some scenarios for approval of FDC or
copackaged products for the treatment of HIV, provided examples of drug
combinations considered acceptable for FDC/copackaging, and examples of
those not considered acceptable for FDC/copackaging. The draft guidance
also explained that the Federal Food, Drug, and Cosmetic Act provides
for certain circumstances in which FDA can grant sponsors a waiver or
reduction in fees. The draft guidance also stated that the agency was
evaluating the circumstances under which it may grant user fee waivers
or reductions for sponsors developing FDC and copackaged versions of
previously approved antiretroviral therapies for the treatment of HIV.
Since issuance of the Fixed Dose Guidance, several potential applicants
have asked that we clarify whether sponsors submitting drug
applications under the Fixed Dose Guidance and under the PEPFAR program
will be required to pay user fees under the Prescription Drug User Fee
Act (PDUFA) and if so, whether they would be eligible for a waiver of
those fees. As explained in this draft guidance, in some of the
scenarios described in the Fixed Dose Guidance, a sponsor could qualify
for fee exemptions or would only be assessed a half-fee either because
the sponsor is using an active ingredient that has already been
approved or the application does not require clinical data for
approval. A sponsor of an application that would be assessed either a
full- or a half-fee may also qualify for a waiver of the application
fee under several provisions of PDUFA.
We expect that most of the applications, products, and
establishments for FDC and copackaged HIV therapies proposed for use in
the PEPFAR program will either not be assessed fees in the first
instance or will qualify for a waiver under the special circumstances
part of the barrier-to-innovation user fee waiver.
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 waivers of
user fees for FDC and copackaged products for the treatment of HIV
under PEPFAR. 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two copies of mailed comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7729 Filed 4-15-05; 8:45 am]
BILLING CODE 4160-01-S