Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 93689-93691 [2016-30676]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Notices
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for comments
regarding an extension to an existing
OMB clearance.
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement concerning the
examination of records by comptroller
general and contract audit. A notice was
published in the Federal Register at 81
FR 62502 on September 9, 2016. No
comments were received.
DATES: Submit comments on or before
January 20, 2017.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC 20503.
Additionally submit a copy to GSA by
any of the following methods:
• Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching for OMB Control No. 9000–
0034. Select the link ‘‘Comment Now’’
that corresponds with ‘‘Information
Collection 9000–0034, Examination of
Records by Comptroller General and
Contract Audit.’’ Follow the instructions
provided on the screen. Please include
your name, company name (if any), and
‘‘Information Collection 9000–0034,
Examination of Records by Comptroller
General and Contract Audit’’ on your
attached document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW.,
Washington, DC 20405. ATTN: Ms.
Flowers/IC 9000–0034, Examination of
Records by Comptroller General and
Contract Audit.
Instructions: Please submit comments
only and cite Information Collection
9000–0034, in all correspondence
related to this collection. Comments
received generally will be posted
without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:38 Dec 20, 2016
Jkt 241001
Mr.
Michael O. Jackson, Procurement
Analyst, Contract Policy Branch, GSA,
202–208–4949 or email
michaelo.jackson@gsa.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
A. Purpose
The objective of this information
collection, for the examination of
records by Comptroller General and
contract audit, is to require contractors
to maintain certain records and to
ensure the Comptroller General and/or
agency have access to, and the right to,
examine and audit records, which
includes: Books, documents, accounting
procedures and practices, and other
data, regardless of type and regardless of
whether such items are in written form,
in the form of computer data, or in any
other form, for a period of three years
after final payment. This information is
necessary for examination and audit of
contract surveillance, verification of
contract pricing, and to provide
reimbursement of contractor costs,
where applicable. The records retention
period is required by the statutory
authorities at 10 U.S.C. 2313, 41 U.S.C.
254, and 10 U.S.C. 2306, and are
implemented through the following
clauses: Audit and Records-Negotiation
clause, 52.215–2; Contract Terms and
Conditions Required to Implement
Statutes or Executive OrdersCommercial Items clause, 52.212–5; and
Audit and Records-Sealed Bidding
clause, 52.214–26. This information
collection does not require contractors
to create or maintain any records that
the contractor does not normally
maintain in its usual course of business.
B. Annual Reporting Burden
Respondents: 20,646.
Responses per Respondent: 9.
Total Number of Responses: 185,814.
Hours per Response: 1.0.
Total Burden Hours: 185,814.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the Federal
Acquisition Regulation (FAR), and
whether it will have practical utility;
whether our estimate of the public
burden of this collection of information
is accurate, and based on valid
assumptions and methodology and ways
to enhance the quality, utility, and
clarity of the information to be
collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
93689
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control Number 9000–0034,
Examination of Records by Comptroller
General and Contract Audit, in all
correspondence.
Dated: December 16, 2016.
Lorin S. Curit,
Director, Federal Acquisition Policy, Office
of Government-wide Acquisition Policy,
Office of Acquisition Policy, Office of
Government-wide Policy.
[FR Doc. 2016–30700 Filed 12–20–16; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
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 information collection provisions of
FDA regulations related to public index
listing of legally marketed unapproved
new animal drugs for minor species of
animals.
DATES: Submit either electronic or
written comments on the collection of
information by February 21, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
E:\FR\FM\21DEN1.SGM
21DEN1
93690
Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0597 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Index of
Legally Marketed Unapproved New
Animal Drugs for Minor Species.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
VerDate Sep<11>2014
18:38 Dec 20, 2016
Jkt 241001
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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.
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species—
21 CFR Part 516
OMB Control Number 0910–0620—
Extension
The Minor Use and Minor Species
Animal Health Act of 2004 (MUMS Act)
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to
authorize FDA to establish new
regulatory procedures intended to make
more medications legally available to
veterinarians and animal owners for the
treatment of minor animal species
(species other than cattle, horses, swine,
chickens, turkeys, dogs, and cats), as
well as uncommon diseases in major
animal species.
Section 572 of the MUMS Act
provided for a public index listing of
legally marketed unapproved new
animal drugs for minor species. FDA
regulations in part 516 (21 CFR part
516) specify, among other things, the
criteria and procedures for requesting
eligibility for indexing and for
requesting addition to the index as well
as the annual reporting requirements for
index holders.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\21DEN1.SGM
21DEN1
93691
Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
516.119
516.121
516.123
516.125
516.129
516.141
516.143
516.145
516.161
516.163
516.165
Number of
responses per
respondent
Number of
respondents
21 CFR part
Total annual
responses
Average
burden per
response
Total hours
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
2
30
3
2
30
20
20
20
1
1
10
1
2
1
3
2
1
1
1
1
1
2
2
60
3
6
60
20
20
20
1
1
20
1
4
8
20
20
16
120
20
4
2
8
2
240
24
120
1,200
320
2,400
400
4
2
160
Total ..............................................................................
........................
........................
........................
........................
4,872
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
516.141 .............................................
516.165 .............................................
Total ...........................................
30
10
........................
2
2
........................
60
20
........................
0.5 (30 minutes) ...............................
1 ........................................................
...........................................................
1 There
30
20
50
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 13, 2016.
Leslie Kux,
Associate Commission for Policy.
[FR Doc. 2016–30676 Filed 12–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy And
Infectious Diseases; Notice of Closed
Meetings
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Total hours
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Peer Review Meeting.
Date: January 13, 2017.
Time: 11:00 a.m. to 3:00 p.m.
VerDate Sep<11>2014
18:38 Dec 20, 2016
Jkt 241001
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Kelly Y. Poe, Scientific
Review Program, Division of Extramural
Activities, Room 3F40B, National Institutes
of Health, NIAID, 5601 Fishers Lane, MSC
9823, Bethesda, MD 20892–9823, (240) 669–
5036, poeky@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Peer Review Meeting.
Date: January 13, 2017.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Kelly Y. Poe, Scientific
Review Program, Division of Extramural
Activities, Room 3F40B, National Institutes
of Health, NIAID, 5601 Fishers Lane, MSC
9823, Bethesda, MD 20892–9823, (240) 669–
5036, poeky@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Peer Review Meeting.
Date: January 27, 2017.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Kelly Y. Poe, Scientific
Review Program, Division of Extramural
Activities, Room 3F40B, National Institutes
of Health, NIAID, 5601 Fishers Lane, MSC
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
9823, Bethesda, MD 20892–9823, (240) 669–
5036, poeky@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 15, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–30691 Filed 12–20–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Notices]
[Pages 93689-93691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30676]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species
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
provisions of FDA regulations related to public index listing of
legally marketed unapproved new animal drugs for minor species of
animals.
DATES: Submit either electronic or written comments on the collection
of information by February 21, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your
[[Page 93690]]
comment will be made public, you are solely responsible for ensuring
that your comment does not include any confidential information that
you or a third party may not wish to be posted, such as medical
information, your or anyone else's Social Security number, or
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0597 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Index of Legally Marketed
Unapproved New Animal Drugs for Minor Species.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species--21 CFR Part 516
OMB Control Number 0910-0620--Extension
The Minor Use and Minor Species Animal Health Act of 2004 (MUMS
Act) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
authorize FDA to establish new regulatory procedures intended to make
more medications legally available to veterinarians and animal owners
for the treatment of minor animal species (species other than cattle,
horses, swine, chickens, turkeys, dogs, and cats), as well as uncommon
diseases in major animal species.
Section 572 of the MUMS Act provided for a public index listing of
legally marketed unapproved new animal drugs for minor species. FDA
regulations in part 516 (21 CFR part 516) specify, among other things,
the criteria and procedures for requesting eligibility for indexing and
for requesting addition to the index as well as the annual reporting
requirements for index holders.
FDA estimates the burden of this collection of information as
follows:
[[Page 93691]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
516.119......................... 2 1 2 1 2
516.121......................... 30 2 60 4 240
516.123......................... 3 1 3 8 24
516.125......................... 2 3 6 20 120
516.129......................... 30 2 60 20 1,200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2,400
516.145......................... 20 1 20 20 400
516.161......................... 1 1 1 4 4
516.163......................... 1 1 1 2 2
516.165......................... 10 2 20 8 160
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,872
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
516.141....................... 30 2 60 0.5 (30 minutes) 30
516.165....................... 10 2 20 1............... 20
Total..................... .............. .............. .............. ................ 50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 13, 2016.
Leslie Kux,
Associate Commission for Policy.
[FR Doc. 2016-30676 Filed 12-20-16; 8:45 am]
BILLING CODE 4164-01-P
