80 FR 72727 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 224 (November 20, 2015)

Page Range		72727-72728
FR Document		2015-29663

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.

Federal Register, Volume 80 Issue 224 (Friday, November 20, 2015)

[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72727-72728]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0145]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Improving Food Safety 
and Defense Capacity of the State and Local Level: Review of State and 
Local Capacities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 72728]]

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 
December 21, 2015.

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 0910-0726. 
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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

Improving Food Safety and Defense Capacity at the State and Local 
Level: Review of State and Local Capacities OMB Control Number 0910-
0726--Extension

    The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) states 
that a review must be conducted to assess the State and local 
capacities to show needs for enhancement in the areas or staffing 
levels, laboratory capacities, and information technology systems. This 
mandate referenced in FSMA section 110 stating that a review of current 
food safety and food defense capabilities must be presented to Congress 
no later than 2 years after the date of enactment (enactment date 
January 4, 2011). This review was completed in 2013 through this 
information collection request.
    This collection provided a baseline measurement of the nation's 
current food safety and food defense capabilities; FDA wants to renew 
this information collection to gather more data. By renewing this 
collection, FDA will be able to analyze the gaps and trends at the 
State and local levels, allowing FDA and its partners to develop ways 
to create a national integrated food safety system.
    FDA will conduct the survey electronically, allowing FDA to conduct 
streamlined analysis while creating a low-burden, user-friendly 
environment for respondents to complete the survey. Once the results 
have been tabulated, FDA and its partners can assess the current 
progress towards an integrated food safety system.
    In the Federal Register of August 31, 2015 (80 FR 46025), 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
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current State and Local Government Employees.......................           1,400                1            1,400                1            1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: November 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29663 Filed 11-19-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices 72727

offering of alternative non-opioid pain ++ Detailed descriptions of the and 1890A(e) of the Act and develop the
management, discussion of safe storage suggested topic area(s) and specific IRF PEC Survey into a quality measure
and proper disposal of opioids, purpose(s). that we may consider proposing for
screening for overdose risk, and review ++ Relevant peer-reviewed journal adoption in the IRF Quality Reporting
the history of substance use), discharge articles or full citations. Program (QRP). In accordance with
planning, family training, rehabilitation • When submitting publicly available section 102 of the Medicare Access and
services, medical and nursing care, instruments or survey questions, we CHIP Reauthorization Act of 2015
interdisciplinary team goal setting and encourage including to the extent (MACRA) (Pub. L. 114–110), the PRA
care planning. We are also soliciting available the following information: shall not apply to the collection of
information on publicly available ++ Name of the instrument. information for the development of
instruments for capturing patients’ and ++ Indication that the instrument is quality measures.
family members’ experiences with IRF publicly available. Also, as stated earlier in section I. of
care in a variety of formats (for example, ++ Copies of the full instrument in all this RFI, we will develop the CMS IRF
standardized, computer readable format) available languages. PEC Survey in accordance with
that can be collected by providers or ++ Topic areas included in the CAHPS® Survey Design Principles and
CAHPS® survey vendors. We are instrument. are developing this survey and plans to
interested in suggested topic areas and ++ Measures that can be derived from submit the resulting instrument to
publicly available instruments that can data collected using the instrument. AHRQ for recognition as a CAHPS®
measure the quality of care from the ++ Instrument reliability (internal survey. Upon receiving recognition as a
patients’ and/or family members’ consistency, test-retest, etc.) and CAHPS® survey and prior to
perspective in IRFs within acute-care validity (content, construct, criterion implementation, CMS will submit the
hospitals, critical access hospitals, and related). CAHPS recognized IRF PEC Survey
free-standing facilities; instruments that ++ Results of cognitive testing (one- through the OMB approval process. At
can be used to track changes over time; on-one testing with a small number of that time, the public will have the
and items that are developed for and/or respondents to ensure that they opportunity to review, comment, or
can be modified to address low case understand the questionnaire.) review and comment on the proposed
volume. Existing instruments are ++ Results of field testing. information collection request prior to
preferred if they have been tested, have ++ Current use of the instrument its submission to OMB for review and
been found to have a high degree of (who is using it, what it is being used approval.
reliability and validity, and for which for, what population it is being used
with, how instrument findings are IV. Response to Comments
there is evidence of wide use in one or
more patient care settings, including reported, and by whom the findings are Because of the large number of public
those in rural and frontier communities. used). comments we normally receive on
Instruments capable of risk adjustment, ++ Relevant peer-reviewed journal Federal Register documents, we are not
and/or instruments that minimize articles or full citations. able to acknowledge or respond to them
++ CAHPS® trademark status. individually. We will consider all
duplication of efforts and/or that utilize
++ NQF endorsement status. comments we receive by the date and
common quality measures, where
++ Survey administration time specified in the DATES section of
available, are preferred. Whenever
instructions. this preamble, and, when we proceed
possible, preference will be given to
++ Data analysis instructions. with a subsequent document, we will
quality measures identified by the ++ Guidelines for reporting survey
Secretary under section 1139A or 1139B respond to the comments in the
data.
of the Act, or endorsed under section preamble to that document.
If you wish to provide comments on
1890 of the Act. this information collection, please Dated: November 6, 2015.
The following information would be submit your comments as specified in Andrew M. Slavitt,
especially helpful in any comments the ADDRESSES section of this request for Acting Administrator, Centers for Medicare
responding to this request for information. & Medicaid Services.
information: Comments must be received on/by [FR Doc. 2015–29623 Filed 11–19–15; 8:45 am]
• A brief cover letter summarizing the January 19, 2016. BILLING CODE 4120–01–P
information requested for submitted
instruments and topic areas, III. Collection of Information
respectively, and how the submitted Requirements
DEPARTMENT OF HEALTH AND
materials could be used to help fulfil the This RFI does not impose any HUMAN SERVICES
intent of the survey. information collection requirements. We
• (Optional) Information about the believe it is a solicitation of comments Food and Drug Administration
person submitting the materials for the from the general public. As stated in the
purpose of follow-up questions about implementing regulations of the [Docket No. FDA–2012–N–0145]
the submission, which includes the Paperwork Reduction Act of 1995 (PRA)
at 5 CFR 1320.3(h)(4), it is exempt from Agency Information Collection
following:
the requirements of the PRA (44 U.S.C. Activities; Submission for Office of
++ Name. Management and Budget Review;
++ Title. 3501 et seq.).
The data collected via this RFI will be Comment Request; Improving Food
++ Organization. Safety and Defense Capacity of the
tkelley on DSK3SPTVN1PROD with NOTICES

used to develop the IRF PEC Survey.
++ Mailing address. While surveys are generally subject to State and Local Level: Review of State
++ Telephone number. the requirements of the PRA, we believe and Local Capacities
++ Email address. the IRF PEC Survey is exempt. Section AGENCY: Food and Drug Administration,
• When submitting topic areas, we I. of this RFI explains that we plan to HHS.
encourage including, to the extent collect this information in support of
ACTION: Notice.
available, the following information: the NQS and, under sections 1886(j)(7)

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72728 Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices

SUMMARY: The Food and Drug Spring, MD 20993–0002, PRAStaff@ This collection provided a baseline
Administration (FDA) is announcing fda.hhs.gov. measurement of the nation’s current
that a proposed collection of SUPPLEMENTARY INFORMATION: In food safety and food defense
information has been submitted to the compliance with 44 U.S.C. 3507, FDA capabilities; FDA wants to renew this
Office of Management and Budget has submitted the following proposed information collection to gather more
(OMB) for review and clearance under collection of information to OMB for data. By renewing this collection, FDA
the Paperwork Reduction Act of 1995. review and clearance. will be able to analyze the gaps and
DATES: Fax written comments on the trends at the State and local levels,
Improving Food Safety and Defense allowing FDA and its partners to
collection of information by December Capacity at the State and Local Level:
21, 2015. develop ways to create a national
Review of State and Local Capacities integrated food safety system.
ADDRESSES: To ensure that comments on OMB Control Number 0910–0726— FDA will conduct the survey
the information collection are received, Extension electronically, allowing FDA to conduct
OMB recommends that written streamlined analysis while creating a
The Food Safety Modernization Act
comments be faxed to the Office of low-burden, user-friendly environment
(FSMA) (Pub. L. 111–353) states that a
Information and Regulatory Affairs, for respondents to complete the survey.
review must be conducted to assess the
OMB, Attn: FDA Desk Officer, FAX: Once the results have been tabulated,
State and local capacities to show needs
202–395–7285, or emailed to oira_ FDA and its partners can assess the
for enhancement in the areas or staffing
submission@omb.eop.gov. All current progress towards an integrated
levels, laboratory capacities, and
comments should be identified with the food safety system.
information technology systems. This
OMB control number 0910–0726. Also
mandate referenced in FSMA section In the Federal Register of August 31,
include the FDA docket number found
110 stating that a review of current food 2015 (80 FR 46025), FDA published a
in brackets in the heading of this
safety and food defense capabilities 60-day notice requesting public
document.
must be presented to Congress no later comment on the proposed collection of
FOR FURTHER INFORMATION CONTACT: FDA than 2 years after the date of enactment information. No comments were
PRA Staff, Office of Operations, Food (enactment date January 4, 2011). This received.
and Drug Administration, 8455 review was completed in 2013 through FDA estimates the burden of this
Colesville Rd., COLE–14526, Silver this information collection request. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Current State and Local Government Employees ............... 1,400 1 1,400 1 1,400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: November 17, 2015. (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, is a version of the drug that was
Leslie Kux, and 10 mg/80 mg, were not withdrawn previously approved. ANDA applicants
Associate Commissioner for Policy. from sale for reasons of safety or do not have to repeat the extensive
[FR Doc. 2015–29663 Filed 11–19–15; 8:45 am] effectiveness. This determination will clinical testing otherwise necessary to
BILLING CODE 4164–01–P
allow FDA to approve abbreviated new gain approval of a new drug application
drug applications (ANDAs) for (NDA).
ezetimibe and atorvastatin tablets, 10 The 1984 amendments include what
DEPARTMENT OF HEALTH AND mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, is now section 505(j)(7) of the Federal
HUMAN SERVICES and 10 mg/80 mg, if all other legal and Food, Drug, and Cosmetic Act (21 U.S.C.
regulatory requirements are met. 355(j)(7)), which requires FDA to
Food and Drug Administration publish a list of all approved drugs.
FOR FURTHER INFORMATION CONTACT: Kate
FDA publishes this list as part of the
[Docket No. FDA–2015–P–3404] Greenwood, Center for Drug Evaluation
‘‘Approved Drug Products With
and Research, Food and Drug
Determination That LIPTRUZET Therapeutic Equivalence Evaluations,’’
Administration, 10903 New Hampshire
(Ezetimibe and Atorvastatin) Tablets, which is known generally as the
Ave., Bldg. 51, Rm. 6217, Silver Spring,
10 Milligrams/10 Milligrams, 10 ‘‘Orange Book.’’ Under FDA regulations,
MD 20993–0002, 240–402–1748.
Milligrams/20 Milligrams, 10 drugs are removed from the list if the
SUPPLEMENTARY INFORMATION: In 1984, Agency withdraws or suspends
Milligrams/40 Milligrams, and 10
Congress enacted the Drug Price approval of the drug’s NDA or ANDA
Milligrams/80 Milligrams, Were Not
Competition and Patent Term for reasons of safety or effectiveness or
Withdrawn From Sale for Reasons of
Restoration Act of 1984 (Pub. L. 98–417) if FDA determines that the listed drug
Safety or Effectiveness
(the 1984 amendments), which was withdrawn from sale for reasons of
AGENCY: Food and Drug Administration, authorized the approval of duplicate safety or effectiveness (21 CFR 314.162).
tkelley on DSK3SPTVN1PROD with NOTICES

HHS. versions of drug products under an A person may petition the Agency to
ACTION: Notice. ANDA procedure. ANDA applicants determine, or the Agency may
must, with certain exceptions, show that determine on its own initiative, whether
SUMMARY: The Food and Drug the drug for which they are seeking a listed drug was withdrawn from sale
Administration (FDA or Agency) has approval contains the same active for reasons of safety or effectiveness.
determined that LIPTRUZET (ezetimibe ingredient in the same strength and This determination may be made at any
and atorvastatin) tablets, 10 milligrams dosage form as the ‘‘listed drug,’’ which time after the drug has been withdrawn

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Document Created: 2015-12-14 13:58:47
Document Modified: 2015-12-14 13:58:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by December 21, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 72727

80 FR 72727 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 224 (November 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration