Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards, 38994 [2019-16937]
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38994
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
Food and Drug Administration
OMB control number 0910–0601. Also
include the FDA docket number found
in brackets in the heading of this
document.
[Docket No. FDA–2010–N–0414]
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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.
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
9, 2019.
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
SUMMARY:
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:
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 document entitled
‘‘Manufactured Food Regulatory
Program Standards.’’ These program
standards are the framework that States
should use to design and manage their
manufactured food programs. There are
43 State programs enrolled, which
receive an average of $230,000
(maximum of $300,000) each year for a
period of 5 years from the year they first
enroll, provided there is significant
conformance with and/or maintenance
of 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. FDA suggests that the
State program 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 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.
In the Federal Register of April 17,
2019 (84 FR 16020), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Respondent
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden
per
response
Total hours
State Departments of Agriculture or Health ........................
43
1
43
569
24,467
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden
per recordkeeping
Total hours
State Departments of Agriculture or Health ........................
43
10
430
40
17,200
jbell on DSK3GLQ082PROD with NOTICES
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
One additional State has enrolled in
the program since 2016. The total
estimated burden of this collection has
increased to 41,667 hours among 43
respondents, from a previous total of
15,792 hours among 42 respondents.
This increase is due to a change in the
self-reported response times provided
by the respondents. Because this is a
long-term program, we believe this
change is the result of more precise
documentation by participating agencies
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
as they have grown more experienced
over time.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2973]
[FR Doc. 2019–16937 Filed 8–7–19; 8:45 am]
Fabry Disease: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
BILLING CODE 4164–01–P
PO 00000
AGENCY:
Food and Drug Administration,
HHS.
Frm 00068
Fmt 4703
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08AUN1
]]>Agencies
[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Page 38994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16937]
[[Page 38994]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0414]
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 9, 2019.
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 [email protected]. 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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 document entitled ``Manufactured Food
Regulatory Program Standards.'' These program standards are the
framework that States should use to design and manage their
manufactured food programs. There are 43 State programs enrolled, which
receive an average of $230,000 (maximum of $300,000) each year for a
period of 5 years from the year they first enroll, provided there is
significant conformance with and/or maintenance of 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. FDA suggests that the State program 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 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.
In the Federal Register of April 17, 2019 (84 FR 16020), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Respondent Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Departments of Agriculture or Health......................... 43 1 43 569 24,467
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
Respondent Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Departments of Agriculture or Health......................... 43 10 430 40 17,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
One additional State has enrolled in the program since 2016. The
total estimated burden of this collection has increased to 41,667 hours
among 43 respondents, from a previous total of 15,792 hours among 42
respondents. This increase is due to a change in the self-reported
response times provided by the respondents. Because this is a long-term
program, we believe this change is the result of more precise
documentation by participating agencies as they have grown more
experienced over time.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16937 Filed 8-7-19; 8:45 am]
BILLING CODE 4164-01-P
