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, 15764-15765 [2012-6391]
Download as PDF
<![CDATA[
15764
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
collection of information to OMB for
review and clearance.
Filing Objections and Requests for a
Hearing on a Regulation or Order—21
CFR Part 12 (OMB Control Number
0910–0184)—Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371(e)(2)), set forth the
instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d) (21 CFR
12.20(d)). Objections and requests must
be submitted within the time specified
in § 12.20(e). Each objection, for which
a hearing has been requested, must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under § 12.24 (21 CFR 12.24)
and do not limit the evidence that may
be presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
In accordance with 5 CFR 1320.8(d),
FDA published a 60-day notice for
public comment in the Federal Register
of September 9, 2011 (76 FR 55922), to
which the Agency received two
comments. However, these comments
did not address the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
12.22 .....................................................................................
1 There
Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6393 Filed 3–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0747]
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
mstockstill on DSK4VPTVN1PROD with NOTICES
1
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Mar<15>2010
17:10 Mar 15, 2012
Jkt 226001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 16,
2012.
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:
202–395–7285, or emailed to
oira_submission@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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
ACTION:
3
Average
burden per
response
Total annual
responses
3
20
Total hours
60
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
collection of information is based on
past filings. Agency personnel
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order
estimate approximately three requests
are received by the Agency annually,
with each requiring approximately 20
hours of preparation time.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Waiver of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles—21 CFR 514.1(b)(7) and (b)(8)
(OMB Control Number 0910–0575)—
Extension
The Center for Veterinary Medicine
has written this guidance to address a
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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 (Pub. L.
100–670) permitted 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 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
E:\FR\FM\16MRN1.SGM
16MRN1
15765
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
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: ‘‘USP
definition’’ approach or ‘‘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 in tables 1 and
2 of this document. The source of the
above data is records of generic drug
applications over the past 10 years.
In the Federal Register of October 24,
2011 (76 FR 65733), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment, which, however, did not
address the questions posed in 60-day
notice regarding the collection of
information. The comment supported
the bioequivalence program but
suggested a revision to the
determination of bioequivalence, which
relates to the substance of the scientific
recommendations in the guidance
document. Under FDA’s good guidance
practices regulations (21 CFR
10.115(f)(4)), the public may suggest at
anytime that FDA revise a guidance
document and under 21 CFR
10.115(g)(5), FDA will revise guidance
documents in response to comments
when appropriate.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Same formulation/manufacturing process approach ...........
Same API/solubility approach ..............................................
1
5
1
5
1
5
5
10
5
50
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
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Same formulation/manufacturing process approach ...........
Same API/solubility approach ..............................................
2
10
2
10
2
10
5
20
10
200
Total burden hours .......................................................
........................
........................
........................
........................
210
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 028’’ (Recognition List
Number: 028), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
[FR Doc. 2012–6391 Filed 3–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
028
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
SUMMARY:
VerDate Mar<15>2010
17:10 Mar 15, 2012
Jkt 226001
Submit either electronic or
written comments concerning this
document at any time. See section VII
of this document for the effective date
of the recognition of standards
announced in this document.
DATES:
[Docket No. FDA–2004–N–0451]
Submit written requests for
single copies of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 028’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993. Send two self-
ADDRESSES:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
addressed adhesive labels to assist that
office in processing your requests, or fax
your request to 301–847–8149. Submit
electronic comments concerning this
document to standards@cdrh.fda.gov.
Submit written comments concerning
this document, or recommendations for
additional standards for recognition, to
the contact person (see FOR FURTHER
INFORMATION CONTACT). This document
may also be accessed on FDA’s Internet
site at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI of this document for electronic access
to the searchable database for the
current list of FDA recognized
consensus standards, including
Recognition List Number: 028
modifications and other standards
related information.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15764-15765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6391]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0747]
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 April
16, 2012.
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: 202-395-7285, or emailed to oira_submission@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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
Juanmanuel.vilela@fda.hhs.gov.
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 514.1(b)(7) and (b)(8) (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
(Pub. L. 100-670) permitted 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 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
[[Page 15765]]
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: ``USP definition'' approach or ``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 in tables 1 and 2 of this
document. The source of the above data is records of generic drug
applications over the past 10 years.
In the Federal Register of October 24, 2011 (76 FR 65733), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment, which, however,
did not address the questions posed in 60-day notice regarding the
collection of information. The comment supported the bioequivalence
program but suggested a revision to the determination of
bioequivalence, which relates to the substance of the scientific
recommendations in the guidance document. Under FDA's good guidance
practices regulations (21 CFR 10.115(f)(4)), the public may suggest at
anytime that FDA revise a guidance document and under 21 CFR
10.115(g)(5), FDA will revise guidance documents in response to
comments when appropriate.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing 1 1 1 5 5
process approach...............
Same API/solubility approach.... 5 5 5 10 50
-------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing 2 2 2 5 10
process approach...............
Same API/solubility approach.... 10 10 10 20 200
-------------------------------------------------------------------------------
Total burden hours.......... .............. .............. .............. .............. 210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6391 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P
