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, 65733-65734 [2011-27392]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0747]
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.
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 current burden hours on regulated
industry of complying with the
guidance underlying this collection of
information.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by December 23, 2011.
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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, PI50–400B, 1350
Piccard Dr., Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
DATES:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:34 Oct 21, 2011
Jkt 226001
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.
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—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.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
65733
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
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.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\24OCN1.SGM
24OCN1
65734
Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1
Number of Respondents
Number of Responses per
Respondent
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
Total Annual
Responses
Average Burden per Response
Total Hours
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 Responses per
Respondent
No. of Respondents
Total Annual
Responses
Average Burden per Response
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: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27392 Filed 10–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0733]
Guidance for Industry on Evaluating
the Safety of Flood-Affected Food
Crops for Human Consumption;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Guidance for Industry: Evaluating the
Safety of Flood-Affected Food Crops for
Human Consumption.’’ Flooding events
can present a potentially hazardous
public health risk. Flood waters may
have been exposed to sewage,
chemicals, heavy metals, pathogenic
microorganisms, or other contaminants.
The growers are responsible to ensure
the safety of the flood-affected food
crops. The guidance is intended to
provide growers information on how to
evaluate the safety of flood-affected food
crops for human consumption.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Plant and Dairy Food Safety,
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:34 Oct 21, 2011
Jkt 226001
Center for Food Safety and Applied
Nutrition (HFS–317), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Yinqing Ma, Center for Food Safety and
Applied Nutrition/Office of Food Safety,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD,
240–402–2479.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Evaluating the Safety of Flood-affected
Food Crops for Human Consumption’’
This guidance is being issued consistent
with FDA’s good guidance practices
(GGP) regulation (§ 10.115 (21 CFR
10.115)). This guidance is being
implemented without prior public
comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
guidance deals with highly timesensitive issues and requires immediate
implementation for public health
reasons. Although this guidance
document is immediately in effect, it
remains subject to comment in
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
accordance with the Agency’s GGPs
regulation.
The guidance is intended to provide
growers information on how to evaluate
the safety of flood-affected food crops
for human consumption. The
recommendations in this guidance are
consistent with existing FDA’s positions
on the safety of flood-affected food
crops. This guidance reiterates FDA’s
positions and includes additional
information to help growers assess the
safety of food from flood-affected crops
for human consumption. Specifically,
the guidance addresses: (1) Safety of
food crops when flood waters contacted
the edible portions of the crops, (2)
safety of food crops when flood waters
did not contact the edible portions of
the crops, (3) assessment of floodaffected fields before replanting, and (4)
additional controls to avoid crosscontamination after flooding.
The guidance represents the Agency’s
current thinking on the safety of floodaffected food crops for human
consumption. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65733-65734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27392]
[[Page 65733]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0747]
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 current burden hours on
regulated industry of complying with the guidance underlying this
collection of information.
DATES: Submit either electronic or written comments on the collection
of information by December 23, 2011.
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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, PI50-400B, 1350
Piccard Dr., Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
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.
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--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 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 65734]]
Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of Responses per Total Annual Average Burden Total Hours
Respondents Respondent Responses per 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\
----------------------------------------------------------------------------------------------------------------
No. of
No. of Responses per Total Annual Average Burden Total Hours
Respondents Respondent Responses per 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: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27392 Filed 10-21-11; 8:45 am]
BILLING CODE 4160-01-P
