Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards, 7544-7546 [2016-02888]
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Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
Ultrahigh Molecular Weight
Polyethylene (UHMWPE) Used in
Orthopedic Devices.’’ 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.
An electronic copy of the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Characterization of
Ultrahigh Molecular Weight
Polyethylene (UHMWPE) Used in
Orthopedic Devices’’ to the Office of the
VerDate Sep<11>2014
17:38 Feb 11, 2016
Jkt 238001
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Peter Allen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 1512, Silver Spring,
MD 20993–0002, 301–796–6402.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘Characterization of
Ultrahigh Molecular Weight
Polyethylene (UHMWPE) Used in
Orthopedic Devices’’. FDA has
developed this guidance document for
members of industry who submit, and
FDA staff who review, information
regarding orthopedic devices using
UHMWPE material. This guidance is
intended to provide recommendations
when finalized regarding the
characterization and testing of
orthopedic devices that use UHMWPE
materials such as conventional
UHMWPE, highly crosslinked
UHMWPE, and highly crosslinked
UHMWPE containing vitamin E. This
document also outlines the information
FDA recommends industry include in a
submission to FDA to characterize the
UHMWPE material (e.g., material
description, sterility, biocompatibility,
mechanical properties, and chemical
properties).
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on UHMWPE used in orthopedic
devices. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
PO 00000
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at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Characterization of Ultrahigh
Molecular Weight Polyethylene
(UHMWPE) Used in Orthopedic
Devices’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
1300006 to identify the guidance you
are requesting.
IV. Paperwork Reduction Act of 1995
The guidance document
‘‘Characterization of Ultrahigh
Molecular Weight Polyethylene
(UHMWPE) Used in Orthopedic
Devices’’ refers to previously approved
information collections found in FDA
regulations and guidance. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E, are
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 812 are
approved under OMB control number
0910–0078; the collections of
information in 21 CFR part 814,
subparts B and E, are approved under
OMB control number 0910–0231; the
collections of information in 21 CFR
part 814, subpart H, are approved under
OMB control number 0910–0332; and
the collections of information in the
guidance document entitled ‘‘Requests
for Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ are
approved under OMB control number
0910–0756.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02879 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0115]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Manufactured
Food Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
E:\FR\FM\12FEN1.SGM
12FEN1
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
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
‘‘Manufactured Food Regulatory
Program Standard.’’
DATES: Submit either electronic or
written comments on the collection of
information by April 12, 2016.
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
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’’).
asabaliauskas on DSK9F6TC42PROD with NOTICES2
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.’’
VerDate Sep<11>2014
17:38 Feb 11, 2016
Jkt 238001
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0115 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Manufactured Food Regulatory Program
Standards.’’ 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
PO 00000
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7545
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.
SUPPLEMENTARY INFORMATION:
Manufactured Food Regulatory
Program Standards—OMB Control
Number 0910–0601—Extension
In the Federal Register of July 20,
2006 (71 FR 41221), FDA announced the
availability of a draft document entitled
‘‘Manufactured Food Regulatory
Program Standards (MFRPS).’’ These
program standards are the framework
that States should use to design and
manage their manufactured food
programs. There are 42 State programs
enrolled, which may receive up to
$300,000 each year for a period of 5
years provided there is significant
conformance with the 10 standards.
In the first year of implementing the
program standards, the State program
conducts a baseline self-assessment to
determine if it meets the elements of
each standard. The State program
should use the worksheets and forms
contained in the draft program
standards; however, it can use alternate
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12FEN1
7546
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
forms that are equivalent. The State
program maintains the documents and
verifies records required for each
standard. The information contained in
the documents must be current and fitfor-use. If the State program fails to meet
all program elements and
documentation requirements of a
standard, it develops a strategic plan
which includes the following: (1) The
individual element of documentation
requirement of the standard that was not
met, (2) improvements needed to meet
the program element or documentation
requirement of the standard, and (3)
projected completion dates for each
task.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Respondent
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
State Departments of Agriculture or Health ........................
42
1
42
750
31,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated as
750 hours per respondent. This burden
was determined by capturing the
average amount of time for each
respondent to assess the current state of
the program and work toward
implementation of each of the 10
standards contained in MFRPS. The
hours per respondent will change as
accounted for in the continuing
improvement and self-sufficiency of the
program.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02888 Filed 2–11–16; 8:45 am]
information entitled ‘‘Request for
Samples and Protocols’’ 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
0910–0206. The approval expires on
December 31, 2018. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–02882 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–N–0114]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Request for Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Request for Samples and Protocols’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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: On
September 24, 2015, the Agency
submitted a proposed collection of
asabaliauskas on DSK9F6TC42PROD with NOTICES2
17:38 Feb 11, 2016
[Docket No. FDA–2016–N–0001]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting
AGENCY:
SUMMARY:
VerDate Sep<11>2014
Food and Drug Administration
Jkt 238001
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastrointestinal
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 7, 2016, from 8 a.m. to 5
p.m.
PO 00000
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Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Cindy Hong, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533,
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 207999,
obeticholic acid oral tablets, submitted
by Intercept Pharmaceuticals, Inc.,
proposed for the treatment of primary
biliary cirrhosis in combination with
ursodeoxycholic acid (UDCA) in adults
with an inadequate response to UDCA
or as monotherapy in adults unable to
tolerate UDCA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
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]]>Agencies
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7544-7546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02888]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0115]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Manufactured Food Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
[[Page 7545]]
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 ``Manufactured Food Regulatory
Program Standard.''
DATES: Submit either electronic or written comments on the collection
of information by April 12, 2016.
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 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-2013-N-0115 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Manufactured Food Regulatory
Program Standards.'' 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, 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.
Manufactured Food Regulatory Program Standards--OMB Control Number
0910-0601--Extension
In the Federal Register of July 20, 2006 (71 FR 41221), FDA
announced the availability of a draft document entitled ``Manufactured
Food Regulatory Program Standards (MFRPS).'' These program standards
are the framework that States should use to design and manage their
manufactured food programs. There are 42 State programs enrolled, which
may receive up to $300,000 each year for a period of 5 years provided
there is significant conformance with the 10 standards.
In the first year of implementing the program standards, the State
program conducts a baseline self-assessment to determine if it meets
the elements of each standard. The State program should use the
worksheets and forms contained in the draft program standards; however,
it can use alternate
[[Page 7546]]
forms that are equivalent. The State program maintains the documents
and verifies records required for each standard. The information
contained in the documents must be current and fit-for-use. If the
State program fails to meet all program elements and documentation
requirements of a standard, it develops a strategic plan which includes
the following: (1) The individual element of documentation requirement
of the standard that was not met, (2) improvements needed to meet the
program element or documentation requirement of the standard, and (3)
projected completion dates for each task.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Respondent Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Departments of Agriculture or Health......................... 42 1 42 750 31,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated as 750 hours per respondent. This
burden was determined by capturing the average amount of time for each
respondent to assess the current state of the program and work toward
implementation of each of the 10 standards contained in MFRPS. The
hours per respondent will change as accounted for in the continuing
improvement and self-sufficiency of the program.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02888 Filed 2-11-16; 8:45 am]
BILLING CODE 4164-01-P
