Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability, 33096-33097 [E8-13099]
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33096
Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Notices
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA approved for marketing the
human biologic product ROTATEQ
(Rotavirus Vaccine, Live, Oral,
Pentavalent). ROTATEQ is indicated for
the prevention of rotavirus
gastroenteritis in infants and children
caused by the serotypes G1, G2, G3, and
G4, when administered as a 3-dose
series to infants between the ages of 6
to 32 weeks. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for ROTATEQ (U.S. Patent
No. 5,626,851) from the Wistar Institute
of Anatomy and Biology and the
Children’s Hospital of Philadelphia, and
the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
February 28, 2007, FDA advised the
Patent and Trademark Office that this
human biological product had
undergone a regulatory review period
and that the approval of ROTATEQ
represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ROTATEQ is 4,577 days. Of this time,
4,272 days occurred during the testing
phase of the regulatory review period,
while 305 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: July 26, 1993. The
applicants claim June 18, 1993, as the
date the investigational new drug
application (IND) became effective.
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16:13 Jun 10, 2008
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However, FDA records indicate that the
IND effective date was July 26, 1993,
when the IND was removed from
clinical hold and studies in humans
could proceed.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): April 5, 2005. FDA has
verified the applicants’ claim that the
biologics license application (BLA) for
ROTATEQ (BLA 125122) was initially
submitted on April 5, 2005.
3. The date the application was
approved: February 3, 2006. FDA has
verified the applicants’ claim that BLA
125122 was approved on February 3,
2006.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
these applicants seek 1,751 days of
patent term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by August 11, 2008.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 8, 2008. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information 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. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
PO 00000
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Dated: May 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–13109 Filed 6–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0324]
Summaries of Medical and Clinical
Pharmacology Reviews of Pediatric
Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies submitted in
supplements for ABILIFY (aripiprazole),
ANDROGEL (testosterone), and
DIOVAN (valsartan). These summaries
are being made available consistent with
the Best Pharmaceuticals for Children
Act, enacted in 2002, (the 2002 BPCA).
For all pediatric supplements submitted
under the 2002 BPCA, the 2002 BPCA
required FDA to make available to the
public, including by publication in the
Federal Register, a summary of the
medical and clinical pharmacology
reviews of the pediatric studies
conducted for the supplement.
ADDRESSES: Submit written requests for
single copies of the summaries 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. Please
specify by product name which
summary or summaries you are
requesting. Send one self-addressed
adhesive label to assist that office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the summaries.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6460,
Silver Spring, MD 20993–0002, 301–
796–0700, e-mail:
grace.carmouze@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
summaries of medical and clinical
E:\FR\FM\11JNN1.SGM
11JNN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Notices
pharmacology reviews of pediatric
studies conducted for ABILIFY
(aripiprazole), ANDROGEL
(testosterone), and DIOVAN (valsartan).
The summaries are being made available
consistent with section 9 of the 2002
BPCA (Public Law 107–109). Enacted on
January 4, 2002, the 2002 BPCA
reauthorized, with certain important
changes, the pediatric exclusivity
program described in section 505A of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355a). Section
505A of the act permits certain
applications to obtain 6 months of
marketing exclusivity if, in accordance
with the requirements of the statute, the
sponsor submits requested information
relating to the use of the drug in the
pediatric population.
One of the provisions the 2002 BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the 2002 BPCA, the 2002 BPCA
required FDA to make available to the
public, including by publication in the
Federal Register, a summary of the
medical and clinical pharmacology
reviews of pediatric studies conducted
for the supplement within 180 days of
study submission to FDA (21 U.S.C.
355a(j)(1)).
The pediatric exclusivity program
described in section 505A of the act
again was reauthorized on September
27, 2007, in title V of the Food and Drug
Administration Amendments Act
(FDAAA) (Public Law 110–85). FDAAA
revised the public dissemination
provision previously found in 21 U.S.C.
355a(j)(1). As revised, not later than 210
days after the date of submission of a
report on a pediatric study conducted
under the pediatric exclusivity program,
FDA must make available to the public
the medical, statistical, and clinical
pharmacology reviews of the pediatric
studies (21 U.S.C. 355a(k)(1)). Under
FDAAA, publication in the Federal
Register is no longer required. FDA
currently posts these reviews on the
Internet at https://www.fda.gov/cder/
pediatric/BpcaPrea_full_review.htm.
The three sets of summaries being
announced in this issue of the Federal
Register are the last summaries of
reviews of supplements subject to the
2002 BPCA dissemination provision.
Because publication in the Federal
Register is no longer required, this will
be the last notice announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies conducted under the
pediatric exclusivity program. FDA has
posted on the Internet at https://
www.fda.gov/cder/pediatric/index.htm
VerDate Aug<31>2005
16:13 Jun 10, 2008
Jkt 214001
summaries of medical and clinical
pharmacology reviews of pediatric
studies submitted in supplements for
ABILIFY (aripiprazole), ANDROGEL
(testosterone), and DIOVAN (valsartan).
Copies are also available by mail (see
ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/pediatric/index.htm.
Dated: June 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–13099 Filed 6–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
HIV/AIDS Bureau; Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
Health Resources and Services
Administration, HHS.
ACTION: Final notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
amending the uniform waiver standards
for Ryan White HIV/AIDS Program
grantees requesting a core medical
services waiver for fiscal year (FY) 2009
and beyond. Title XXVI of the Public
Health Service (PHS) Act, as amended
by the Ryan White HIV/AIDS Treatment
Modernization Act of 2006 (Ryan White
HIV/AIDS Program), requires that
grantees expend 75 percent of Parts A,
B, and C funds on core medical services,
including antiretroviral drugs, for
individuals with HIV/AIDS identified
and eligible under the legislation. HRSA
has issued waiver standards for grantees
under Parts A, B, and C of Title XXVI
of the PHS Act. This Federal Register
notice seeks to make public the final
notice of Uniform Standard for Waiver
of Core Medical Services Requirements
for Grantees Under Parts A, B, and C
effective FY 2009.
SUPPLEMENTARY INFORMATION: The Ryan
White HIV/AIDS Program imposes two
criteria for waiver eligibility: (1) no
waiting lists for AIDS Drug Assistance
Program (ADAP) services; and (2) core
medical services availability within the
relevant service area to all individuals
with HIV/AIDS identified and eligible
under Title XXVI of the PHS Act. (See
sections 2604(c)(2), 2612(b)(2), and
2651(c)(2) of the PHS Act.) HRSA’s HIV/
PO 00000
Frm 00033
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33097
AIDS Bureau issued interim waiver
eligibility guidance for FY 2007 to
provide immediate implementation of
these waiver provisions. The final
Uniform Standard for Waiver of Core
Medical Services Requirements for
Grantees Under Parts A, B, and C
reflects modifications based on public
comment received in response to the
guidance published in the Federal
Register on November 27, 2007. During
the 30-day comment period ending
December 26, 2007, HAB received
comments from the public.
Beginning in FY 2009, HRSA will
utilize new standards for granting
waivers of the core medical services
requirement for Ryan White HIV/AIDS
Program grantees. These standards meet
the intent of the Ryan White HIV/AIDS
Treatment Modernization Act of 2006 to
increase access to core medical services,
including antiretroviral drugs, for
persons with HIV/AIDS and to ensure
that grantees receiving waivers
demonstrate the availability of such
services for individuals with HIV/AIDS
identified and eligible under Title XXVI
of the PHS Act. The purposes of this
notice are: (1) To establish a uniform
standard for core medical services
waiver eligibility for grantees under
Parts A, B, and C of Title XXVI of the
PHS Act; and (2) to establish a process
for waiver request submission, review
and notification. The core medical
services waiver uniform standard and
waiver request process in this notice
apply to Ryan White HIV/AIDS Program
grant awards under Parts A, B, and C of
Title XXVI of the PHS Act effective for
the FY 2009 grant year.
Comments on the Proposed Uniform
Standard for Waiver of Core Medical
Services Requirements for Grantees
Under Parts A, B, and C
There were several public comments
in strong support of the draft policy
stating that the proposed changes allow
more funds to be allocated to life-saving
core medical services, including
medications. The following suggestions
and concerns were the main issues
raised in the public comments.
Issue (1): Types of Documentation and
Evidence Required as Part of the Waiver
Request.
(Comment) Submission of
documentation letters from private
payers should be optional, not required.
(Response) HRSA concurs with the
suggestion and changed the sentence
regarding private insurers to ‘‘letters
from Medicaid and other State and local
HIV/AIDS entitlement and benefits
programs, which may include private
insurers’’.
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 73, Number 113 (Wednesday, June 11, 2008)]
[Notices]
[Pages 33096-33097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13099]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0324]
Summaries of Medical and Clinical Pharmacology Reviews of
Pediatric Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of summaries of medical and clinical pharmacology reviews
of pediatric studies submitted in supplements for ABILIFY
(aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). These
summaries are being made available consistent with the Best
Pharmaceuticals for Children Act, enacted in 2002, (the 2002 BPCA). For
all pediatric supplements submitted under the 2002 BPCA, the 2002 BPCA
required FDA to make available to the public, including by publication
in the Federal Register, a summary of the medical and clinical
pharmacology reviews of the pediatric studies conducted for the
supplement.
ADDRESSES: Submit written requests for single copies of the summaries
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. Please specify by product
name which summary or summaries you are requesting. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the summaries.
FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6460, Silver Spring, MD 20993-0002, 301-
796-0700, e-mail: grace.carmouze@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of summaries of medical and
clinical
[[Page 33097]]
pharmacology reviews of pediatric studies conducted for ABILIFY
(aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). The
summaries are being made available consistent with section 9 of the
2002 BPCA (Public Law 107-109). Enacted on January 4, 2002, the 2002
BPCA reauthorized, with certain important changes, the pediatric
exclusivity program described in section 505A of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the
act permits certain applications to obtain 6 months of marketing
exclusivity if, in accordance with the requirements of the statute, the
sponsor submits requested information relating to the use of the drug
in the pediatric population.
One of the provisions the 2002 BPCA added to the pediatric
exclusivity program pertains to the dissemination of pediatric
information. Specifically, for all pediatric supplements submitted
under the 2002 BPCA, the 2002 BPCA required FDA to make available to
the public, including by publication in the Federal Register, a summary
of the medical and clinical pharmacology reviews of pediatric studies
conducted for the supplement within 180 days of study submission to FDA
(21 U.S.C. 355a(j)(1)).
The pediatric exclusivity program described in section 505A of the
act again was reauthorized on September 27, 2007, in title V of the
Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-
85). FDAAA revised the public dissemination provision previously found
in 21 U.S.C. 355a(j)(1). As revised, not later than 210 days after the
date of submission of a report on a pediatric study conducted under the
pediatric exclusivity program, FDA must make available to the public
the medical, statistical, and clinical pharmacology reviews of the
pediatric studies (21 U.S.C. 355a(k)(1)). Under FDAAA, publication in
the Federal Register is no longer required. FDA currently posts these
reviews on the Internet at https://www.fda.gov/cder/pediatric/BpcaPrea_
full_review.htm.
The three sets of summaries being announced in this issue of the
Federal Register are the last summaries of reviews of supplements
subject to the 2002 BPCA dissemination provision. Because publication
in the Federal Register is no longer required, this will be the last
notice announcing the availability of summaries of medical and clinical
pharmacology reviews of pediatric studies conducted under the pediatric
exclusivity program. FDA has posted on the Internet at https://
www.fda.gov/cder/pediatric/index.htm summaries of medical and clinical
pharmacology reviews of pediatric studies submitted in supplements for
ABILIFY (aripiprazole), ANDROGEL (testosterone), and DIOVAN
(valsartan). Copies are also available by mail (see ADDRESSES).
II. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/cder/pediatric/index.htm.
Dated: June 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13099 Filed 6-10-08; 8:45 am]
BILLING CODE 4160-01-S
