Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards, 53148-53149 [2016-19165]
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53148
Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices
3. Are the conclusions supported by
the data?
4. Are the tables clear and
appropriate?
5. Is the document organized
appropriately? If not, what
improvements are needed?
6. Are you aware of any scientific data
reported in governmental publications,
databases, peer-reviewed journals, or
other sources that should be included
within this document?
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2016–19051 Filed 8–10–16; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0115]
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 September
12, 2016.
SUMMARY:
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Manufactured Food Regulatory
Program Standards—OMB Control
Number 0910–0601—Extension
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Manufactured
Food Regulatory Program Standards
AGENCY:
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 0910–0601. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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 have since been
finalized and updated multiple times.
The current standards are the
framework that States should use to
design and manage their manufactured
food programs. The current version
expires on September 30, 2016, and
FDA is proposing to update and submit
for issuance with a new expiration date.
The current and proposed versions of
the standards are available at the docket
number identified in brackets at the
heading of this document. Persons with
access to the Internet may submit email
requests for a single copy of the draft
manufactured food standards to OPORA@fda.hhs.gov. There are 42 State
programs enrolled, in which each State
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
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
improvement plan that includes the
following: (1) The individual program
element or 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.
In the Federal Register of February
12, 2016 (81 FR 7544), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. We received two
comments. However, these comments
did not address the information
collection.
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
376
15,792
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices
The burden has been calculated as
376 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: August 8, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation and Analysis.
[FR Doc. 2016–19165 Filed 8–10–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0971]
Infectious Disease Next Generation
Sequencing Based Diagnostic
Devices: Microbial Identification and
Detection of Antimicrobial Resistance
and Virulence Markers; Draft Guidance
for Industry and Food and Drug
Administration Staff; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
period.
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
document entitled ‘‘Infectious Disease
Next Generation Sequencing Based
Diagnostic Devices: Microbial
Identification and Detection of
Antimicrobial Resistance and Virulence
Markers; Draft Guidance for Industry
and Food and Drug Administration
Staff,’’ that appeared in the Federal
Register of May 13, 2016. In the
document, FDA requested comments on
FDA’s recommendations to assist
industry in designing studies to
establish the analytical and clinical
performance characteristics of infectious
disease next generation sequencingbased diagnostic devices for microbial
identification and detection of
antimicrobial resistance and virulence
markers. The Agency is taking this
action in response to a request for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment
period on the document published May
13, 2016 (81 FR 29869). Submit either
sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014
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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
Notice; extension of comment
SUMMARY:
electronic or written comments by
September 12, 2016.
ADDRESSES: You may submit comments
as follows:
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–
2016–D–0971 for ‘‘Infectious Disease
Next Generation Sequencing Based
Diagnostic Devices: Microbial
Identification and Detection of
Antimicrobial Resistance and Virulence
Markers; Draft Guidance for Industry
and Food and Drug Administration
Staff.’’ 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
PO 00000
Frm 00032
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53149
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:
Heike Sichtig, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4526, Silver Spring,
MD 20993–0002, Heike.Sichtig@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 13,
2016 (81 FR 29869), FDA published a
document with a 90-day comment
period to request comments on the types
of studies the FDA recommends to
support a premarket application of
Infectious Disease Next Generation
(NGS) Sequencing Based Diagnostic
E:\FR\FM\11AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Pages 53148-53149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19165]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0115]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Manufactured Food
Regulatory Program Standards
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
September 12, 2016.
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 0910-0601.
Also include the FDA 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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
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
have since been finalized and updated multiple times. The current
standards are the framework that States should use to design and manage
their manufactured food programs. The current version expires on
September 30, 2016, and FDA is proposing to update and submit for
issuance with a new expiration date. The current and proposed versions
of the standards are available at the docket number identified in
brackets at the heading of this document. Persons with access to the
Internet may submit email requests for a single copy of the draft
manufactured food standards to OP-ORA@fda.hhs.gov. There are 42 State
programs enrolled, in which each State 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 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 improvement plan that includes the following: (1) The
individual program element or 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.
In the Federal Register of February 12, 2016 (81 FR 7544), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments. However, these
comments did not address the information collection.
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 42 376 15,792
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 53149]]
The burden has been calculated as 376 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: August 8, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2016-19165 Filed 8-10-16; 8:45 am]
BILLING CODE 4164-01-P
