Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 14095-14096 [2013-04827]
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<![CDATA[
14095
Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Notices
involved in the response. The number of
samples tested during a response to a
possible event could range from 10,000
to more than 500,000 samples
depending on the length and breadth of
the event. Since there is potentially a
large range in the number of samples for
a surge event, CDC estimates the
annualized burden for this event will be
2,250,000 hours or 625 responses per
respondent.
There is no cost to the respondents
other than their time. The total
estimated annualized burden is
2,382,300 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Laboratories ..............................
Public Health Laboratories ..............................
Public Health Laboratories ..............................
Biennial Requalification ..................................
General Surveillance Testing Results ............
Proficiency Testing/Validation Testing Results.
Surge Event Testing Results .........................
Public Health Laboratories ..............................
Dated: February 26, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Agency Recordkeeping/Reporting
Requirements Under Emergency
Review by the Office of Management
and Budget (OMB)
[FR Doc. 2013–04900 Filed 3–1–13; 8:45 am]
BILLING CODE 4163–18–P
Title: TANF Quarterly Financial
Report, ACF–196.
OMB No.: 0970–0247.
Description: This information
collection is authorized under Section
411(a)(3) of the Social Security Act. This
request is for revision of approval to use
the Administration for Children and
Families’ (ACF) 196 form for periodic
Number of
responses per
respondent
Avg. burden
per response
(in hrs)
150
150
150
1
25
5
2
24
56
150
625
24
financial reporting under the Temporary
Assistance for Needy Families (TANF)
program. States participating in the
TANF program are required by statute to
report financial data on a quarterly
basis. This form meets the legal
standard and provides essential data on
the use of Federal funds. Failure to
collect the data would seriously
compromise ACF’s ability to monitor
program expenditures, estimate funding
needs, and to prepare budget
submissions required by Congress.
Financial reporting under the TANF
program is governed by 45 CFR part
265. This renewal restores columns for
reporting Emergency Contingency Fund
and Supplemental Grant expenditures.
Respondents: TANF Agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–196 ..........................................................................................................
51
4
10
2040
Washington, DC 20503; FAX: (202) 395–
7285; email:
oira_submission@omb.eop.gov.
Estimated Total Annual Burden
Hours: 2040.
sroberts on DSK5SPTVN1PROD with NOTICES
Additional Information
ACF is requesting that OMB grant a
180 day approval for this information
collection under procedures for
emergency processing by March 15,
2013. A copy of this information
collection, with applicable supporting
documentation, may be obtained by
emailing the Administration for
Children and Families, Reports
Clearance Officer: rsargis@acf.hhs.gov.
Comments and questions about the
information collection described above
should be directed to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for ACF, Office
of Management and Budget, Paperwork
Reduction Project; 725 17th Street NW.,
VerDate Mar<15>2010
17:54 Mar 01, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
[Docket No. FDA–2012–P–1071]
[FR Doc. 2013–04826 Filed 3–1–13; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
Food and Drug Administration
Determination That GEREF (Sermorelin
Acetate) Injection, 0.5 Milligrams Base/
Vial and 1.0 Milligrams Base/Vial, and
GEREF (Sermorelin Acetate) Injection,
0.05 Milligrams Base/Amp, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that GEREF (Sermorelin Acetate)
SUMMARY:
Frm 00025
Fmt 4703
Sfmt 4703
E:\FR\FM\04MRN1.SGM
04MRN1
sroberts on DSK5SPTVN1PROD with NOTICES
14096
Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Notices
injection, 0.5 milligrams (mg) base/vial
and 1.0 mg base/vial, and GEREF
(Sermorelin Acetate) injection, 0.05 mg
base/amp, were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for GEREF
(Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, and
GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kathy Schreier, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6252,
Silver Spring, MD 20993–0002, 301–
796–3432.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
VerDate Mar<15>2010
16:15 Mar 01, 2013
Jkt 229001
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
GEREF (Sermorelin Acetate) injection,
0.5 mg base/vial and 1.0 mg base/vial,
is the subject of NDA 20–443, held by
EMD Serono, and initially approved on
September 26, 1997; and GEREF
(Sermorelin Acetate) injection, 0.05 mg
base/amp, is the subject of NDA 19–863,
held by EMD Serono, and initially
approved on December 28, 1990. GEREF
(Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, is
indicated for the treatment of idiopathic
growth hormone deficiency (GHD) in
children with growth failure, and
GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, is indicated for
evaluating the ability of the somatotroph
of the pituitary gland to secrete growth
hormone.
In a letter dated December 2, 2008,
EMD Serono notified FDA that GEREF
(Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, was
being discontinued and requested
withdrawal of NDA 20–443; and FDA
moved that drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In a letter
dated July 11, 2008, EMD Serono also
notified FDA that GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp,
was being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book as well. In
addition, in a letter dated December 12,
2008, EMD Serono requested
withdrawal of NDA 19–863 for GEREF
(Sermorelin Acetate) injection, 0.05 mg
base/amp. In the Federal Register of
May 19, 2009 (74 FR 23407), FDA
announced that it was withdrawing
approval of NDA 19–863 and NDA 20–
443, effective June 18, 2009.
Alvin J. Lorman submitted a citizen
petition dated October 12, 2012 (Docket
No. FDA–2012–P–1071), under 21 CFR
10.30, requesting that the Agency
determine whether GEREF (Sermorelin
Acetate) injection, 0.5 mg base/vial and
1.0 mg base/vial, was withdrawn from
the market for reasons of safety and
efficacy. Although the citizen petition
did not request that we determine
whether GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, approved
under NDA 19–863, was withdrawn for
safety or efficacy, that product has also
been discontinued. On our own
initiative, we have also determined
whether GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, was
withdrawn for safety or effectiveness
reasons.
After considering the citizen petition
and reviewing Agency records and
PO 00000
Frm 00026
Fmt 4703
Sfmt 9990
based on the information we have at this
time, FDA has determined under
§ 314.161 that GEREF (Sermorelin
Acetate) injection, 0.5 mg base/vial and
1.0 mg base/vial, and GEREF
(Sermorelin Acetate) injection, 0.05 mg
base/amp, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that GEREF
(Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, and
GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
GEREF (Sermorelin Acetate) injection,
0.5 mg base/vial and 1.0 mg base/vial,
and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events for both
GEREF products. We have reviewed the
available evidence and determined that
both GEREF products were not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list GEREF (Sermorelin
Acetate) injection, 0.5 mg base/vial and
1.0 mg base/vial, and GEREF
(Sermorelin Acetate) injection, 0.05 mg
base/amp, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to GEREF (Sermorelin
Acetate) injection, 0.5 mg base/vial and
1.0 mg base/vial, and GEREF
(Sermorelin Acetate) injection, 0.05 mg
base/amp, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: February 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04827 Filed 3–1–13; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14095-14096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-P-1071]
Determination That GEREF (Sermorelin Acetate) Injection, 0.5
Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF
(Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
GEREF (Sermorelin Acetate)
[[Page 14096]]
injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and
GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Kathy Schreier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6252, Silver Spring, MD 20993-0002, 301-
796-3432.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg
base/vial, is the subject of NDA 20-443, held by EMD Serono, and
initially approved on September 26, 1997; and GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp, is the subject of NDA 19-863,
held by EMD Serono, and initially approved on December 28, 1990. GEREF
(Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial,
is indicated for the treatment of idiopathic growth hormone deficiency
(GHD) in children with growth failure, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, is indicated for evaluating the ability of
the somatotroph of the pituitary gland to secrete growth hormone.
In a letter dated December 2, 2008, EMD Serono notified FDA that
GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/
vial, was being discontinued and requested withdrawal of NDA 20-443;
and FDA moved that drug product to the ``Discontinued Drug Product
List'' section of the Orange Book. In a letter dated July 11, 2008, EMD
Serono also notified FDA that GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book as well. In addition, in a letter dated December 12, 2008, EMD
Serono requested withdrawal of NDA 19-863 for GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp. In the Federal Register of May
19, 2009 (74 FR 23407), FDA announced that it was withdrawing approval
of NDA 19-863 and NDA 20-443, effective June 18, 2009.
Alvin J. Lorman submitted a citizen petition dated October 12, 2012
(Docket No. FDA-2012-P-1071), under 21 CFR 10.30, requesting that the
Agency determine whether GEREF (Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, was withdrawn from the market for
reasons of safety and efficacy. Although the citizen petition did not
request that we determine whether GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, approved under NDA 19-863, was withdrawn for safety
or efficacy, that product has also been discontinued. On our own
initiative, we have also determined whether GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, was withdrawn for safety or effectiveness
reasons.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that GEREF (Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, were not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that GEREF (Sermorelin Acetate) injection, 0.5
mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of GEREF (Sermorelin Acetate) injection, 0.5
mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events for both GEREF products. We have reviewed the available
evidence and determined that both GEREF products were not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list GEREF (Sermorelin
Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF
(Sermorelin Acetate) injection, 0.05 mg base/amp, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to GEREF (Sermorelin Acetate)
injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp, may be approved by the Agency as
long as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: February 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04827 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P
