Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles, 2598-2599 [E9-782]
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2598
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices
EXHIBIT 3—ESTIMATED COST—Continued
Cost component
Total cost
Annualized
cost
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................
70,569
41,420
68,908
76,320
47,046
27,613
45,939
50,880
Total ..................................................................................................................................................................
399,961
266,641
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: December 30, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E9–537 Filed 1–14–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on PROD1PC65 with NOTICES
[Docket No. FDA–2008–N–0543]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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:
ACTION:
Food and Drug Administration,
Notice.
VerDate Nov<24>2008
18:58 Jan 14, 2009
Jkt 217001
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr.,Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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
BILLING CODE 4160–90–M
HHS.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
17, 2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submissions@OMB.eop.gov. All
comments should be identified with the
OMB control number 0910–0575. Also
include the FDA docket number found
in brackets in the heading of this
document.
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
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
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.
In the Federal Register of October 29,
2008 (73 FR 64338), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15JAN1.SGM
15JAN1
2599
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices
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
Annual Frequency
of Responses
Total Annual
Responses
Hours per
Response
2
2
2
5
10
10
Same API/solubility approach
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.
The sources of the previous data are
records of generic drug applications
over the past 10 years.
Dated: January 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–782 Filed 1–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Guidance for Clinical Investigators,
Sponsors, and Institutional Review
Boards on Adverse Event Reporting—
Improving Human Subject Protection;
Availability
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Adverse Event Reporting—
Improving Human Subject Protection.’’
This guidance is intended to assist the
research community in interpreting
requirements for submitting reports of
unanticipated problems, including
certain adverse events reports, to
institutional review boards (IRBs). FDA
developed this guidance in response to
concerns raised by the IRB community
that increasingly large volumes of
individual, unanalyzed adverse event
VerDate Nov<24>2008
18:58 Jan 14, 2009
Jkt 217001
reports are inhibiting, rather than
enhancing, the ability of IRBs to
adequately protect human subjects. The
guidance provides recommendations to
IRBs, sponsors, and investigators on
improving the usefulness of the adverse
event information submitted to IRBs.
Elsewhere in this issue of the Federal
Register, FDA is issuing the final rule
entitled ‘‘Institutional Review Boards;
Registration Requirements.’’
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the 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. Submit written comments on
the 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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
ADDRESSES:
[Docket No. FDA–2007–D–0202] (formerly
Docket No. 2007D–0106)
AGENCY:
Total Hours
FOR FURTHER INFORMATION CONTACT:
Joseph Griffin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–2270, e-mail:
Joseph.Griffin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
I. Background
FDA is announcing the availability of
a guidance for clinical investigators,
sponsors, and IRBs entitled ‘‘Adverse
Event Reporting—Improving Human
Subject Protection.’’ Under the
regulations in 21 CFR part 50
(Protection of Human Subjects), part 56
(21 CFR part 56) (Institutional Review
Boards), part 312 (21 CFR part 312)
(Investigational New Drug Application),
and part 812 (21 CFR part 812)
(Investigational Device Exemptions), an
IRB must review and approve a clinical
study before the study is initiated.
Additionally, after an IRB’s initial
review and approval, an IRB must
conduct continuing review of the study
at intervals appropriate to the degree of
risk presented by the study, at least
annually. The primary purpose of both
the initial review of a study and the
periodic review of the conduct of the
study is to ensure the protection of the
rights and welfare of human subjects. To
do its job, an IRB must be informed of
any unanticipated problems in the study
and any changes in the research activity.
This guidance discusses adverse event
reporting to IRBs by sponsors and
investigators and emphasizes the value
of well-analyzed adverse event data to
an IRB review.
A notice announcing the draft version
of this guidance published in the
Federal Register on April 9, 2007 (72 FR
17562). After carefully considering all
received comments, the agency is
finalizing that guidance. The draft and
the final have relatively minor
substantive differences. The
recommendations section in the final
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Notices]
[Pages 2598-2599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0543]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 17, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submissions@OMB.eop.gov. All
comments should be identified with the OMB control number 0910-0575.
Also include the FDA 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 Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
In the Federal Register of October 29, 2008 (73 FR 64338), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 2599]]
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.
The sources of the previous data are records of generic drug
applications over the past 10 years.
Dated: January 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-782 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-01-S
