Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792, 4272-4273 [2015-01404]
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4272
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Sexual Abuse Significant Incident Report Form ...................................
Assessment of Risk Form .....................................................................
Care Provider Incident Review Form ....................................................
Written policies ......................................................................................
Previous misconduct ..............................................................................
Background checks ...............................................................................
Reporting misconduct of former employees ..........................................
Reporting to investigating authorities ....................................................
MOUs with investigating authorities ......................................................
Training documentation .........................................................................
Information for UCs ...............................................................................
MOUs with reporting entities .................................................................
Grievance procedures ...........................................................................
Agreements with local service providers ...............................................
Third Party reporting ..............................................................................
Disclosure to parent/guardian ................................................................
Disclosure to atty of record ...................................................................
Reporting staff, contractors, and volunteers to investigating authorities
Annual reports .......................................................................................
Quarterly reports ....................................................................................
Other data ..............................................................................................
Audit report ............................................................................................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Instrument
2,430 ................
57,500 ..............
2,430 ................
120 ...................
7,479 ................
748 ...................
75 .....................
2,430 ................
120 ...................
7,479 ................
57,500 ..............
120 ...................
120 ...................
120 ...................
73 or more .......
2,430 ................
972 ...................
25 .....................
120 ...................
120 ...................
120 ...................
40 .....................
1 or more ..........
1 .......................
1 .......................
1 .......................
1 or more ..........
1 or more ..........
1 .......................
1 or more ..........
2 or more ..........
1 .......................
1 .......................
1 .......................
1 .......................
1 or more ..........
1 .......................
1 .......................
1 .......................
1 .......................
1 .......................
4 .......................
20 or more ........
1 .......................
Estimated Total Annual Burden
Hours: 34,713.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
VerDate Sep<11>2014
18:01 Jan 26, 2015
Jkt 235001
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–01372 Filed 1–26–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0194]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Biosimilars User
Fee Cover Sheet; Form FDA 3792
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 information collection in Form FDA
3792, ‘‘Biosimilars User Fee Cover
Sheet’’.
Frm 00030
Fmt 4703
Total burden
hours
0.5
0.17
0.5
2
0.33
0.1
0.33
0.33
0.33
0.17
0.25
0.25
0.5
1
0.25
0.17
0.17
0.25
4
2
0.25
8
1,215 or more.
9,775.
1,215.
240.
2,468.
74.8.
25.
802 or more.
79 or more.
1,271.
14,375.
30.
60.
120.
18 or more.
413.
165.
6.
480.
960.
600.
320.
Submit either electronic or
written comments on the collection of
information by March 30, 2015.
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.
DATES:
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,
SUPPLEMENTARY INFORMATION:
Notice.
SUMMARY:
PO 00000
Average burden
hours per
response
Sfmt 4703
E:\FR\FM\27JAN1.SGM
27JAN1
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
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.
Biosimilars User Fee Cover Sheet; Form
FDA 3792 (OMB Control Number 0910–
0718)—Extension
The Patient Protection and Affordable
Care Act (Pub. L. 111–148) contains a
subtitle called the Biologics Price
Competition and Innovation Act of 2009
(Title VII Subtitle A) (BPCI Act) that
amends the Public Health Service Act
(42 U.S.C. 262) (PHS Act) and other
statutes to create an abbreviated
approval pathway for biological
products shown to be biosimilar to or
interchangeable with an FDA-licensed
reference biological product. Section
351(k) of the PHS Act, added by the
BPCI Act, allows a company to submit
an application for licensure of a
biosimilar or interchangeable biological
product. The BPCI Act also amends
section 735 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g) to
include 351(k) applications in the
definition of ‘‘human drug application’’
for the purposes of the prescription drug
user fee provisions. The BPCI Act
directs FDA to develop
recommendations for a biosimilar
biological product user fee program for
fiscal years 2013 through 2017. FDA’s
recommendations for a biosimilar
biological product user fee program
were submitted to Congress on January
13, 2012.
FDA’s biosimilar biological product
user fee program requires FDA to assess
and collect user fees for certain
meetings concerning biosimilar
4273
biological product development (BPD
meetings), investigational new drug
applications (INDs) intended to support
a biosimilar biological product
application, and biosimilar biological
product applications and supplements.
Form FDA 3792, the Biosimilars User
Fee Cover Sheet, requests the minimum
necessary information to determine the
amount of the fee required, and to
account for and track user fees. The
form provides a cross-reference of the
fees submitted for a submission with the
actual submission by using a unique
number tracking system. The
information collected is used by FDA’s
Center for Drug Evaluation and Research
and Center for Biologics Evaluation and
Research to initiate the administrative
screening of biosimilar biological
product INDs, applications, and
supplements, and to account for and
track user fees associated with BPD
meetings.
Respondents to this collection of
information are manufacturers of
biosimilar biological product
candidates. Based on the number of
Form FDA 3792s we have received, we
estimate the burden of this collection of
information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Biosimilars User Fee Cover Sheet; Form FDA 3792 ..
20
1
20
0.50 (30 minutes) ...
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 21, 2015.
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. 2015–01404 Filed 1–26–15; 8:45 am]
BILLING CODE 4164–01–P
Fax written comments on the
collection of information by February
26, 2015.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1414]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Class II Special
Controls Guidance Document:
Labeling of Natural Rubber Latex
Condoms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
18:01 Jan 26, 2015
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
Notice.
VerDate Sep<11>2014
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 0910–0633. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Jkt 235001
PO 00000
Frm 00031
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:
Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21
CFR 884.5300—(OMB Control Number
0910–0633)—Extension
Under the Medical Device
Amendments of 1976 (Pub. L. 94–295),
class II devices were defined as those
devices for which there was insufficient
information to show that general
controls themselves would provide a
reasonable assurance of safety and
effectiveness but for which there was
sufficient information to establish
performance standards to provide such
assurance.
Condoms without spermicidal
lubricant containing nonoxynol 9 are
E:\FR\FM\27JAN1.SGM
27JAN1
Agencies
[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4272-4273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01404]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0194]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792
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 information collection in
Form FDA 3792, ``Biosimilars User Fee Cover Sheet''.
DATES: Submit either electronic or written comments on the collection
of information by March 30, 2015.
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,
[[Page 4273]]
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.
Biosimilars User Fee Cover Sheet; Form FDA 3792 (OMB Control Number
0910-0718)--Extension
The Patient Protection and Affordable Care Act (Pub. L. 111-148)
contains a subtitle called the Biologics Price Competition and
Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends
the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other
statutes to create an abbreviated approval pathway for biological
products shown to be biosimilar to or interchangeable with an FDA-
licensed reference biological product. Section 351(k) of the PHS Act,
added by the BPCI Act, allows a company to submit an application for
licensure of a biosimilar or interchangeable biological product. The
BPCI Act also amends section 735 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the
definition of ``human drug application'' for the purposes of the
prescription drug user fee provisions. The BPCI Act directs FDA to
develop recommendations for a biosimilar biological product user fee
program for fiscal years 2013 through 2017. FDA's recommendations for a
biosimilar biological product user fee program were submitted to
Congress on January 13, 2012.
FDA's biosimilar biological product user fee program requires FDA
to assess and collect user fees for certain meetings concerning
biosimilar biological product development (BPD meetings),
investigational new drug applications (INDs) intended to support a
biosimilar biological product application, and biosimilar biological
product applications and supplements. Form FDA 3792, the Biosimilars
User Fee Cover Sheet, requests the minimum necessary information to
determine the amount of the fee required, and to account for and track
user fees. The form provides a cross-reference of the fees submitted
for a submission with the actual submission by using a unique number
tracking system. The information collected is used by FDA's Center for
Drug Evaluation and Research and Center for Biologics Evaluation and
Research to initiate the administrative screening of biosimilar
biological product INDs, applications, and supplements, and to account
for and track user fees associated with BPD meetings.
Respondents to this collection of information are manufacturers of
biosimilar biological product candidates. Based on the number of Form
FDA 3792s we have received, we estimate the burden of this collection
of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosimilars User Fee Cover Sheet; Form FDA 20 1 20 0.50 (30 minutes)...................... 10
3792.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01404 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P