Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 24130-24131 [2017-10736]
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24130
Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
2. Form CMS–20017 with complete
contact information that includes name,
address, phone number, and email
addresses for all presenters and
commenters and a contact person that
can answer any questions, and provide
revisions that are requested, for the
presentation. Presenters and
commenters must clearly explain the
actions that they are requesting CMS to
take in the appropriate section of the
form. A presenter’s or commenter’s
relationship with the organization that
they represent must also be clearly
listed.
• The form is now available through
the CMS Forms Web site at: https://
www.cms.gov/Medicare/CMS-Forms/
CMS-Forms/downloads/cms20017.pdf.
• We encourage presenters to make
efforts to ensure that their presentations
and comments are 508 compliant.
IV. Oral Comments
In addition to formal oral
presentations, which are limited to 5
minutes total per presentation, there
will be an opportunity during the
meeting for public oral comments,
which will be limited to 1 minute for
each individual and a total of 3 minutes
per organization.
V. Meeting Attendance
The meeting is open to the public;
however, attendance is limited to space
available. Priority will be given to those
who pre-register and attendance may be
limited based on the number of
registrants and the space available.
Persons wishing to attend this
meeting, which is located on federal
property, must register by following the
instructions in the DATES section of this
notice under ‘‘Meeting Registration
Timeframe’’. A confirmation email will
be sent to the registrants shortly after
completing the registration process.
VI. Security, Building, and Parking
Guidelines
The following are the security,
building, and parking guidelines:
• Persons attending the meeting,
including presenters, must be preregistered and on the attendance list by
the prescribed date.
• Individuals who are not preregistered in advance may not be
permitted to enter the building and may
be unable to attend the meeting.
• Attendees must present a
government-issued photo identification
to the Federal Protective Service or
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18:04 May 24, 2017
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Guard Service personnel before entering
the building. Without a current, valid
photo ID, persons may not be permitted
entry to the building.
• Security measures include
inspection of vehicles, inside and out, at
the entrance to the grounds.
• All persons entering the building
must pass through a metal detector.
• All items brought into CMS,
including personal items, for example,
laptops and cell phones, are subject to
physical inspection.
• The public may enter the building
30 to 45 minutes before the meeting
convenes each day.
• All visitors must be escorted in
areas other than the lower and first-floor
levels in the Central Building.
• The main-entrance guards will
issue parking permits and instructions
upon arrival at the building.
• Foreign nationals visiting any CMS
facility require prior approval. If you are
a foreign national and wish to attend the
meeting onsite, in addition to registering
for the meeting, you must also send a
separate email to APCPanel@
cms.hhs.gov prior to the close of
registration to request authorization to
attend as a foreign national.
Note: As of March 30, 2015, the ‘‘Real ID
Act’’ requires a second form of identification
from those whose government issued photo
identification or government issued driver’s
license was issued by American Samoa,
Arizona, Louisiana, Maine, Minnesota, and
New York. Attendees with a government
issued photo identification or driver’s license
issued by the states previously mentioned
may need to provide alternative or additional
approved proof of identification in order to
comply with the ‘‘Real ID Act.’’
VII. Special Accommodations
Individuals requiring special
accommodations must include the
request for these services during
registration.
VIII. Panel Recommendations and
Discussions
The Panel’s recommendations at any
Panel meeting generally are not final
until they have been reviewed and
approved by the Panel on the last day
of the meeting, before the final
adjournment. These recommendations
will be posted to our Web site after the
meeting.
IX. Collection of Information
Requirements
This document does not impose
information collection requirements,
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that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: May 18, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–10683 Filed 5–24–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0879; FDA–
2013–N–0579; FDA–2016–N–2474; FDA–
2016–D–1853; FDA–2013–N–0764; FDA–
2013–N–0825; FDA–2013–N–0797; FDA–
2013–N–0578]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 11601 Landsdown Street,
North Bethesda, MD 20852, 301–796–
7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. 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.
SUMMARY:
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Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
24131
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Procedures for the Safe Processing and Importing of Fish and Fishery Products ................................................
Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations; Form FDA 3486 and Addendum, 3486A .....................................................
Designation of New Animal Drugs for Minor Use or Minor Species .......................................................................
Unique Device Identification System .......................................................................................................................
Animal Feed Regulatory Program Standards .........................................................................................................
Premarket Approval of Medical Devices—21 CFR Part 814 ..................................................................................
Human Tissue Intended for Transplantation ...........................................................................................................
General Licensing Provisions: Biological License Application, Changes to an Approved Application, Labeling,
Revocation and Suspension, and Form FDA 356h .............................................................................................
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislative, and Analysis.
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, 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.
[FR Doc. 2017–10736 Filed 5–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0118]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
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 June 26,
2017.
SUMMARY:
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 0910–0520. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
FOR FURTHER INFORMATION CONTACT:
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Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.278 to
1.285, OMB Control Number 0910–0520
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 381(m)),
which requires that FDA receives prior
notice for food, including food for
animals, that is imported or offered for
import into the United States. Sections
1.278 to 1.282 of FDA regulations (21
CFR 1.278 to 1.282) set forth the
requirements for submitting prior
notice; §§ 1.283(d) and 1.285(j) (21 CFR
1.283(d) and 1.285(j)) set forth the
procedure for requesting the Agency
review after FDA has refused admission
of an article of food under section
801(m)(1) of the FD&C Act or placed an
article of food under hold under section
801(l); and § 1.285(i) sets forth the
procedure for post-hold submissions.
Section 304 of the FDA Food Safety
Modernization Act (FSMA) (Pub. L.
111–353) amended section 801(m) of the
FD&C Act to require a person submitting
prior notice of imported food, including
food for animals, to report, in addition
to other information already required,
‘‘any country to which the article has
been refused entry.’’
Advance notice of imported food
allows FDA, with the support of the
U.S. Customs and Border Protection
(CBP), to target import inspections more
effectively and help protect the nation’s
food supply against terrorist acts and
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Sfmt 4703
Date approval
expires
0910–0354
2/29/2020
0910–0458
0910–0605
0910–0720
0910–0760
0910–0231
0910–0302
2/29/2020
2/29/2020
2/29/2020
2/29/2020
3/31/2020
3/31/2020
0910–0338
3/31/2020
other public health emergencies. By
requiring that a prior notice contain
additional information that indicates
prior refusals by any country and also
identifies the country or countries, the
Agency may better identify imported
food shipments that may pose safety
and security risks to U.S. consumers.
This additional knowledge can further
help FDA to make better informed
decisions in managing the potential
risks of imported food shipments into
the United States.
Any person with knowledge of the
required information may submit prior
notice for an article of food. Thus, the
respondents to this information
collection may include importers,
owners, ultimate consignees, shippers,
and carriers.
FDA regulations require that prior
notice of imported food be submitted
electronically using CBP’s Automated
Broker Interface of the Automated
Commercial System (ABI/ACS)
(§ 1.280(a)(1)) or the FDA Prior Notice
System Interface (PNSI) (Form FDA
3540) (§ 1.280(a)(2)). PNSI is an
electronic submission system available
on the FDA Industry Systems page at
https://www.access.fda.gov/.
Information the Agency collects in the
prior notice submission includes: (1)
The submitter and transmitter (if
different from the submitter); (2) entry
type and CBP identifier; (3) the article
of food, including complete FDA
product code; (4) the manufacturer, for
an article of food no longer in its natural
state; (5) the grower, if known, for an
article of food that is in its natural state;
(6) the FDA Country of Production; (7)
the name of any country that has
refused entry of the article of food; (8)
the shipper, except for food imported by
international mail; (9) the country from
which the article of food is shipped or,
if the food is imported by international
mail, the anticipated date of mailing and
country from which the food is mailed;
(10) the anticipated arrival information
or, if the food is imported by
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]]>Agencies
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24130-24131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10736]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0879; FDA-2013-N-0579; FDA-2016-N-2474; FDA-
2016-D-1853; FDA-2013-N-0764; FDA-2013-N-0825; FDA-2013-N-0797; FDA-
2013-N-0578]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
Street, North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at
https://www.reginfo.gov/public/do/PRAMain. 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.
[[Page 24131]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Procedures for the Safe Processing and 0910-0354 2/29/2020
Importing of Fish and Fishery Products.
Biological Products: Reporting of 0910-0458 2/29/2020
Biological Product Deviations and Human
Cells, Tissues, and Cellular and Tissue-
Based Product Deviations; Form FDA 3486
and Addendum, 3486A....................
Designation of New Animal Drugs for 0910-0605 2/29/2020
Minor Use or Minor Species.............
Unique Device Identification System..... 0910-0720 2/29/2020
Animal Feed Regulatory Program Standards 0910-0760 2/29/2020
Premarket Approval of Medical Devices-- 0910-0231 3/31/2020
21 CFR Part 814........................
Human Tissue Intended for 0910-0302 3/31/2020
Transplantation........................
General Licensing Provisions: Biological 0910-0338 3/31/2020
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension, and Form FDA
356h...................................
------------------------------------------------------------------------
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislative, and Analysis.
[FR Doc. 2017-10736 Filed 5-24-17; 8:45 am]
BILLING CODE 4164-01-P
