Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles, 64338-64340 [E8-25741]
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64338
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per
response
Total burden
hours
Help America Vote Act (HAVA) Voting Access Annual Report ......................
Help America Vote Act (HAVA) Voting Access Application ............................
50
55
1
1
24
50
1,200
2,750
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
3,950
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 Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail 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.
Dated: October 24, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–25752 Filed 10–28–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2008–D–0030] (formerly
Docket No. 2004D–0466)
[Docket No. FDA–2008–N–0543]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Substantiation for Dietary Supplement
Claims Made Under the Federal Food,
Drug, and Cosmetic Act
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Waiver of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Substantiation for Dietary Supplement
Claims Made Under the Federal Food,
Drug, and Cosmetic Act’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 25, 2008 (73
FR 22423), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0626. The
approval expires on August 31, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
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Food and Drug Administration,
HHS.
Dated: October 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25791 Filed 10–28–08; 8:45 am]
VerDate Aug<31>2005
AGENCY:
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Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the waiver requirement procedures that
are recommended by the agency for in
vivo demonstration of bioequivalence
for generic soluble powder oral dosage
form products and Type A medicated
articles.
Submit written or electronic
comments on the collection of
information by December 29, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information 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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
DATES:
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64339
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Waiver of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles—21 CFR Part 514 (OMB
Control Number 0910–0575)—Extension
The Center for Veterinary Medicine
has written this guidance to address a
perceived need for agency guidance in
its work with the animal health
industry. This guidance describes the
procedures that the agency recommends
for the review of requests for waiver of
in vivo demonstration of bioequivalence
for generic soluble powder oral dosage
form products and Type A medicated
articles.
The Generic Animal Drug and Patent
Term Registration Act of 1988 permitted
the generic drug manufacturers to copy
those pioneer drug products that were
no longer subject to patent or other
marketing exclusivity protection. The
approval for marketing these generic
products is based, in part, upon a
demonstration of bioequivalence
between the generic product and the
pioneer product. This guidance clarifies
circumstances under which FDA
believes the demonstration of
bioequivalence required by the statute
does not need to be established on the
basis of in vivo studies for soluble
powder oral dosage form products and
Type A medicated articles. The data
submitted in support of the waiver
request are necessary to validate the
waiver decision.
The requirement to establish
bioequivalence through in vivo studies
(blood level bioequivalence or clinical
endpoint bioequivalence) may be
waived for soluble powder oral dosage
form products or Type A medicated
articles in either of two alternative
ways. A biowaiver may be granted if it
can be shown that the generic soluble
powder oral dosage form product or
Type A medicated article contains the
same active and inactive ingredient(s)
and is produced using the same
manufacturing processes as the
approved comparator product or article.
Alternatively, a biowaiver may be
granted without direct comparison to
the pioneer product’s formulation and
manufacturing process if it can be
shown that the active pharmaceutical
ingredient(s) (API) is the same as the
pioneer product, is soluble, and that
there are no ingredients in the
formulation likely to cause adverse
pharmacologic effects. For the purpose
of evaluating soluble powder oral
dosage form products and Type A
medicated articles, solubility can be
demonstrated in one of two ways: (1)
‘‘USP definition’’ approach, or (2)
‘‘Dosage adjusted’’ approach.
The respondents for this collection of
information are pharmaceutical
companies manufacturing animal drugs.
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Same formulation/manufacturing
process approach
1
1
1
5
5
Same API/ solubility approach
5
5
5
10
50
Total burden hours
1 There
55
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES1
No. of
Respondents
Same formulation/manufacturing
process approach
Total Annual
Responses
Hours per
Response
2
2
5
10
10
10
10
20
200
Total burden hours
1 There
210
are no capital costs or operating and maintenance costs associated with this collection of information.
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17:17 Oct 28, 2008
Total Hours
2
Same API/ solubility approach
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Annual Frequency
of Responses
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64340
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
The sources of the previous data are
records of generic drug applications
over the past 10 years.
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.
Dated: October 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25741 Filed 10–28–08; 8:45 am]
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17:17 Oct 28, 2008
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
scientific and clinical topics, questions,
and problems that may arise. This MOU
also provides the framework for sharing
of information.
[Docket No. FDA–2008–N–0043]
[FDA No. 225–07–1000]
DATES:
Memorandum of Understanding With
the National Heart, Lung, and Blood
Institute, a Part of the National
Institutes of Health
FOR FURTHER INFORMATION CONTACT:
Keith Wonnacott, Cellular Therapy
Branch (HFM–720), Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448, 301–827–5102; or John W.
Thomas, Division of Blood Diseases and
Resources, National Heart, Lung, and
Blood Institute MSC 7950, 6701
Rockledge Dr., Rockledge II, rm. 9150,
Bethesda, MD 20892–7950, 301–435–
0065.
AGENCY:
The agreement became effective
September 11, 2008.
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA’s
Center for Biologics Evaluation and
Research (CBER) and the National Heart,
Lung, and Blood Institute (NHLBI), a
part of the National Institutes of Health
(NIH). This MOU outlines the terms of
collaboration between CBER and NHLBI
in areas of mutual concern for
protecting and improving the public
health. Specifically this MOU provides
for the implementation of a plan for
promoting better communication and
understanding of regulations, policies,
and statutory responsibilities, and to
serve as a forum for discussion of
PO 00000
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In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
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Agencies
[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Notices]
[Pages 64338-64340]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0543]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A
Medicated Articles
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the waiver requirement
procedures that are recommended by the agency for in vivo demonstration
of bioequivalence for generic soluble powder oral dosage form products
and Type A medicated articles.
DATES: Submit written or electronic comments on the collection of
information by December 29, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information 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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug
[[Page 64339]]
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form Products and Type A Medicated
Articles--21 CFR Part 514 (OMB Control Number 0910-0575)--Extension
The Center for Veterinary Medicine has written this guidance to
address a perceived need for agency guidance in its work with the
animal health industry. This guidance describes the procedures that the
agency recommends for the review of requests for waiver of in vivo
demonstration of bioequivalence for generic soluble powder oral dosage
form products and Type A medicated articles.
The Generic Animal Drug and Patent Term Registration Act of 1988
permitted the generic drug manufacturers to copy those pioneer drug
products that were no longer subject to patent or other marketing
exclusivity protection. The approval for marketing these generic
products is based, in part, upon a demonstration of bioequivalence
between the generic product and the pioneer product. This guidance
clarifies circumstances under which FDA believes the demonstration of
bioequivalence required by the statute does not need to be established
on the basis of in vivo studies for soluble powder oral dosage form
products and Type A medicated articles. The data submitted in support
of the waiver request are necessary to validate the waiver decision.
The requirement to establish bioequivalence through in vivo studies
(blood level bioequivalence or clinical endpoint bioequivalence) may be
waived for soluble powder oral dosage form products or Type A medicated
articles in either of two alternative ways. A biowaiver may be granted
if it can be shown that the generic soluble powder oral dosage form
product or Type A medicated article contains the same active and
inactive ingredient(s) and is produced using the same manufacturing
processes as the approved comparator product or article. Alternatively,
a biowaiver may be granted without direct comparison to the pioneer
product's formulation and manufacturing process if it can be shown that
the active pharmaceutical ingredient(s) (API) is the same as the
pioneer product, is soluble, and that there are no ingredients in the
formulation likely to cause adverse pharmacologic effects. For the
purpose of evaluating soluble powder oral dosage form products and Type
A medicated articles, solubility can be demonstrated in one of two
ways: (1) ``USP definition'' approach, or (2) ``Dosage adjusted''
approach.
The respondents for this collection of information are
pharmaceutical companies manufacturing animal drugs.
FDA estimates the burden for this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden for Water Soluble Powders\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Same 1 1 1 5 5
formulation/
manufacturing
process
approach
----------------------------------------------------------------------------------------------------------------
Same API/ 5 5 5 10 50
solubility
approach
----------------------------------------------------------------------------------------------------------------
Total burden hours 55
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden for Type A Medicated Articles\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
Respondents Responses Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Same 2 2 2 5 10
formulation/
manufacturing
process
approach
----------------------------------------------------------------------------------------------------------------
Same API/ 10 10 10 20 200
solubility
approach
----------------------------------------------------------------------------------------------------------------
Total burden hours 210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 64340]]
The sources of the previous data are records of generic drug
applications over the past 10 years.
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.
Dated: October 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25741 Filed 10-28-08; 8:45 am]
BILLING CODE 4160-01-S