Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data, 74727-74728 [2014-29425]
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74727
Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
State High Performance Bonus System (HPBS) Transmission File Layouts
for HPBS Work Measures ............................................................................
25
2
12
600
Estimated Total Annual Burden
Hours: 600.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–29421 Filed 12–15–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and
Developmental Disabilities (AIDD);
Notice of Meeting
President’s Committee for
People with Intellectual Disabilities
(PCPID).
ACTION: Notice of meeting.
AGENCY:
Tuesday, January 27, 2015 from
9:00 a.m. to 4:30 p.m.; and Wednesday,
January 28, 2015 from 9:00 a.m. to 4:00
p.m.
These meetings will be open to the
general public.
ADDRESSES: These meetings will be held
in the U.S. Department of Health and
Human Services/Hubert H. Humphrey
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
19:38 Dec 15, 2014
Jkt 235001
Building located at 200 Independence
Avenue SW., Conference Room 505A,
Washington, DC 20201.
Individuals who would like to
participate via conference call may do
so by dialing toll-free 888–935–0260,
when prompted enter pass code:
3656064. Individuals whose full
participation in the meeting will require
special accommodations (e.g., sign
language interpreting services, assistive
listening devices, materials in
alternative format such as large print or
Braille) should notify Dr. MJ Karimi,
PCPID Team Lead, via email at
MJ.Karimie@acl.hhs.gov, or via
telephone at 202–357–3588, no later
than Friday, January 16, 2015. The
PCPID will attempt to accommodate
requests made after that date, but cannot
guarantee the ability to grant requests
received after this deadline. All meeting
sites are barrier free, consistent with the
Americans with Disabilities Act (ADA)
and the Federal Advisory Committee
Act (FACA).
Agenda: The Committee Members
will discuss preparation of the PCPID
2015 Report to the President, including
its content and format, and related data
collection and analysis required to
complete the writing of the Report. They
will also receive presentations from
selected experts in the field of
Technology for People with Intellectual
and Developmental Disabilities.
Additional Information: For further
information, please contact Dr. MJ
Karimi, Team Lead, President’s
Committee for People with Intellectual
Disabilities, One Massachusetts Avenue
NW., Room 4206, Washington, DC
20201. Telephone: 202–357–3588. Fax:
202–205–8037. Email: MJ.Karimie@
acl.hhs.gov
SUPPLEMENTARY INFORMATION: The
PCPID acts in an advisory capacity to
the President and the Secretary of
Health and Human Services, through
the Administration on Intellectual and
Developmental Disabilities, on a broad
range of topics relating to programs,
services and supports for persons with
intellectual disabilities. The PCPID
Executive Order stipulates that the
Committee shall: (1) Provide such
advice concerning intellectual
disabilities as the President or the
Secretary of Health and Human Services
PO 00000
Frm 00046
Fmt 4703
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may request; and (2) provide advice to
the President concerning the following
for people with intellectual disabilities:
(A) Expansion of educational
opportunities; (B) promotion of
homeownership; (C) assurance of
workplace integration; (D) improvement
of transportation options; (E) expansion
of full access to community living; and
(F) increasing access to assistive and
universally designed technologies.
Dated: December 3, 2014.
Aaron Bishop,
Commissioner, Administration on Intellectual
and Developmental Disabilities (AIDD).
[FR Doc. 2014–29417 Filed 12–15–14; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0809]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements for
Submission of Bioequivalence Data
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 January 15,
2015.
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 0910–0630. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
E:\FR\FM\16DEN1.SGM
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74728
Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
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
has submitted the following proposed
collection of information to OMB for
review and clearance.
Requirements for Submission of In
Vivo Bioequivalence Data—21 CFR
parts 314 and 320.
SUPPLEMENTARY INFORMATION:
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 bioequivalence (BE)
studies, including studies that do not
meet passing bioequivalence criteria,
which are performed on a drug product
formulation submitted for approval
under an abbreviated new drug
application (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, 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]).
In the Federal Register of June 26,
2014 (79 FR 36320), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
314.94(a)(7) .........................................................................
314.96(a)(1) .........................................................................
314.97 ..................................................................................
84
1
1
1
1
1
84
1
1
72
72
72
6,048
72
72
Total ..............................................................................
........................
........................
........................
........................
6,192
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
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.
[FR Doc. 2014–29425 Filed 12–15–14; 8:45 am]
BILLING CODE 4164–01–P
Fax written comments on the
collection of information by January 15,
2015.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 0910–0284. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1409]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
19:38 Dec 15, 2014
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Road; COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
Notice.
Jkt 235001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Spring, MD 20993–0002 PRAStaff@
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:
Records and Reports Concerning
Experiences With Approved New
Animal Drugs: Adverse Event Reports
on Paper Forms FDA 1932, 1932a, and
2301—21 CFR 514.80; OMB Control
Number 0910–0284—Extension
Section 512(l) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360b(l) and 514.80 (21 CFR
514.80) of FDA regulations require
applicants of approved new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) to report adverse drug
experiences and product/manufacturing
defects (see 514.80)(b)). Additionally,
section 571(e)(3) of the FD&C Act (21
U.S.C. 360ccc(e)(3)) requires that
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]]>Agencies
[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74727-74728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0809]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 January
15, 2015.
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 0910-0630.
Also include the FDA docket number found in brackets in the heading of
this document.
[[Page 74728]]
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 bioequivalence (BE) studies, including
studies that do not meet passing bioequivalence criteria, which are
performed on a drug product formulation submitted for approval under an
abbreviated new drug application (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, 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 x 0.2] + [60 x 0.8]).
In the Federal Register of June 26, 2014 (79 FR 36320), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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
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: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29425 Filed 12-15-14; 8:45 am]
BILLING CODE 4164-01-P
