Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Bioequivalence Data, 36320-36321 [2014-14927]
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Federal Register / Vol. 79, No. 123 / Thursday, June 26, 2014 / Notices
subject to review by OMB under the
PRA. The collections of information in
21 CFR part 820 have been approved
under OMB control number 0910–0073,
and the collections of information for
the Inspection by Accredited Persons
Program have been approved under
OMB control number 0910–0569.
Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14924 Filed 6–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0809]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requirements for
Submission of Bioequivalence Data
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 requirement for an abbreviated new
drug application (ANDA) applicant to
submit data from all bioequivalence
(BE) studies the applicant conducts on
a drug product formulation submitted
for approval.
DATES: Submit either electronic or
written comments on the collection of
information by August 25, 2014.
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.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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.
Requirements for Submission of In Vivo
Bioequivalence Data—21 CFR Parts 314
and 320; OMB Control Number 0910–
0630—Extension
In the Federal Register of January 16,
2009 (74 FR 2849), the Agency
published a final rule revising FDA
regulations to require applicants to
submit data on all BE studies, including
studies that do not meet passing
bioequivalence criteria, which are
performed on a drug product
formulation submitted for approval
under an ANDA, or in an amendment or
supplement to an ANDA that contains
BE studies. In the final rule, FDA
amended §§ 314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97 (21 CFR
314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97) to require an
ANDA applicant to submit information
from all BE studies, both passing and
nonpassing, conducted by the applicant
on the same drug product formulation
as that submitted for approval under an
ANDA, amendment, or supplement.
In table 1 of this document, FDA has
estimated the reporting burden
associated with each section of this
requirement. FDA believes that the
majority of additional BE studies will be
reported in ANDAs (submitted under
§ 314.94), rather than supplements
(reported in § 314.97) because it is
unlikely than an ANDA holder will
conduct BE studies with a drug after the
drug has been approved. With respect to
the reporting of additional BE studies in
amendments (submitted under
§ 314.96), this should also account for a
small number of reports because most
BE studies will be conducted on a drug
prior to the submission of the ANDA
and will be reported in the ANDA itself.
FDA estimates applicants will require
approximately 120 hours of staff time to
prepare and submit each additional
complete BE study report and
approximately 60 hours of staff time for
each additional BE summary report. The
Agency believes that a complete report
will be required approximately 20
percent of the time, while a summary
will suffice approximately 80 percent of
the time. Based on a weighted-average
calculation using the information
presented previously in this document,
the submission of each additional BE
study is expected to take 72 hours of
staff time ([120 × 0.2] + [60 × 0.8]).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
314.94(a)(7) .........................................................................
VerDate Mar<15>2010
16:51 Jun 25, 2014
Jkt 232001
PO 00000
Frm 00035
Number of
responses per
respondent
84
Fmt 4703
Sfmt 4703
Total annual
responses
1
E:\FR\FM\26JNN1.SGM
84
26JNN1
Average
burden per
response
72
Total hours
6,048
36321
Federal Register / Vol. 79, No. 123 / Thursday, June 26, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
314.96(a)(1) .........................................................................
314.97 ..................................................................................
1
1
1
1
1
1
72
72
72
72
Total ..............................................................................
........................
........................
........................
........................
6,192
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2014–14927 Filed 6–25–14; 8:45 am]
[FR Doc. 2014–14925 Filed 6–25–14; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Recordkeeping and Records Access
Requirements for Food Facilities—21
CFR 1.337, 1.345, and 1.352 (OMB
Control Number 0910–0560—Extension)
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2011–N–0016]
[Docket No. FDA–2013–N–1423]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Importer’s Entry Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Importer’s Entry Notice’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On June 9,
2014, the Agency submitted a proposed
collection of information entitled
‘‘Importer’s Entry Notice’’ 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
0910–0046. The approval expires on
June 30, 2017. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
and Records Access Requirements for
Food Facilities
VerDate Mar<15>2010
16:51 Jun 25, 2014
Jkt 232001
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 28,
2014.
SUMMARY:
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 0910–0560. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) (Pub. L. 107–188) added section
414 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
350c), which requires that persons who
manufacture, process, pack, hold,
receive, distribute, transport, or import
food in the United States establish and
maintain records identifying the
immediate previous sources and
immediate subsequent recipients of
food. Sections 1.326 through 1.363 of
our regulations (21 CFR 1.326 through
1.363) set forth the requirements for
recordkeeping and records access. The
requirement to establish and maintain
records improves our ability to respond
to, and further contain, threats of
serious adverse health consequences or
death to humans or animals from
accidental or deliberate contamination
of food.
Information maintained under these
regulations will help us to identify and
locate quickly contaminated or
potentially contaminated food and to
inform the appropriate individuals and
food facilities of specific terrorist
threats. Our regulations require that
records for non-transporters include the
name and full contact information of
sources, recipients, and transporters, an
adequate description of the food
including the quantity and packaging,
and the receipt and shipping dates
(§§ 1.337 and 1.345). Required records
for transporters include the names of
consignor and consignee, points of
origin and destination, date of
shipment, number of packages,
description of freight, route of
movement and name of each carrier
participating in the transportation, and
transfer points through which shipment
moved (§ 1.352). Existing records may
be used if they contain all of the
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36320-36321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0809]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements for Submission of Bioequivalence Data
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 requirement for an
abbreviated new drug application (ANDA) applicant to submit data from
all bioequivalence (BE) studies the applicant conducts on a drug
product formulation submitted for approval.
DATES: Submit either electronic or written comments on the collection
of information by August 25, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Requirements for Submission of In Vivo Bioequivalence Data--21 CFR
Parts 314 and 320; OMB Control Number 0910-0630--Extension
In the Federal Register of January 16, 2009 (74 FR 2849), the
Agency published a final rule revising FDA regulations to require
applicants to submit data on all BE studies, including studies that do
not meet passing bioequivalence criteria, which are performed on a drug
product formulation submitted for approval under an ANDA, or in an
amendment or supplement to an ANDA that contains BE studies. In the
final rule, FDA amended Sec. Sec. 314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97 (21 CFR 314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97) to require an ANDA applicant to submit
information from all BE studies, both passing and nonpassing, conducted
by the applicant on the same drug product formulation as that submitted
for approval under an ANDA, amendment, or supplement.
In table 1 of this document, FDA has estimated the reporting burden
associated with each section of this requirement. FDA believes that the
majority of additional BE studies will be reported in ANDAs (submitted
under Sec. 314.94), rather than supplements (reported in Sec. 314.97)
because it is unlikely than an ANDA holder will conduct BE studies with
a drug after the drug has been approved. With respect to the reporting
of additional BE studies in amendments (submitted under Sec. 314.96),
this should also account for a small number of reports because most BE
studies will be conducted on a drug prior to the submission of the ANDA
and will be reported in the ANDA itself.
FDA estimates applicants will require approximately 120 hours of
staff time to prepare and submit each additional complete BE study
report and approximately 60 hours of staff time for each additional BE
summary report. The Agency believes that a complete report will be
required approximately 20 percent of the time, while a summary will
suffice approximately 80 percent of the time. Based on a weighted-
average calculation using the information presented previously in this
document, the submission of each additional BE study is expected to
take 72 hours of staff time ([120 x 0.2] + [60 x 0.8]).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
314.94(a)(7).................... 84 1 84 72 6,048
[[Page 36321]]
314.96(a)(1).................... 1 1 1 72 72
314.97.......................... 1 1 1 72 72
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 6,192
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14927 Filed 6-25-14; 8:45 am]
BILLING CODE 4164-01-P
