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5. Healthcare Effectiveness and
Outcomes Research (HEOR)
Date: February 28–March 1, 2018
(Open from 8:30 a.m. to 9:00 a.m. on
February 28th and closed for remainder
of the meeting).
(below specifics where each
meeting will be held)
Hilton Rockville & Executive Meeting
Center, 1750 Rockville Pike, Rockville,
Maryland 20852.

ADDRESSES:

(to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of the meetings.)
Mrs. Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research Education and
Priority Populations, Agency for
Healthcare Research and Quality
(AHRQ), 5600 Fishers Lane, Rockville,
Maryland 20857, Telephone (301) 427–
1554.

FOR FURTHER INFORMATION CONTACT:

These
meetings will be closed to the public in
accordance with 5 U.S.C. App. 2 section
10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C.
552b(c)(6). In accordance with section
10 (a)(2) of the Federal Advisory
Committee Act (5 U.S.C. App. 2), AHRQ
announces meetings of the above-listed
scientific peer review groups, which are
subcommittees of AHRQ’s Health
Services Research Initial Review Group
Committees. Each subcommittee
meeting will commence in open session
before closing to the public for the
duration of the meeting. The
subcommittee meetings will be closed to
the public in accordance with the
provisions set forth in 5 U.S.C. App. 2
section 10(d), 5 U.S.C. 552b(c)(4), and 5
U.S.C. 552b(c)(6) The grant applications
and the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Agenda items for these meetings are
subject to change as priorities dictate.

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SUPPLEMENTARY INFORMATION:

Dated: January 25, 2018.
Gopal Khanna,
Director.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[CDC–2017–0072; Docket Number NIOSH–
300]

Final National Occupational Research
Agenda for Manufacturing
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:

NIOSH announces the
availability of the final National
Occupational Research Agenda for
Manufacturing

SUMMARY:

The final document was
published on January 25, 2018.
ADDRESSES: The document may be
obtained at the following link: https://
www.cdc.gov/niosh/nora/sectors/
manuf/researchagenda.html.
FOR FURTHER INFORMATION CONTACT:
Emily Novicki, M.A., M.P.H,
([email protected]), National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, Mailstop E–20, 1600 Clifton
Road NE, Atlanta, GA 30329, phone
(404) 498–2581 (not a toll free number).
SUPPLEMENTARY INFORMATION: On August
23, 2017, NIOSH published a request for
public review in the Federal Register
[82 FR 40003] of the draft version of the
National Occupational Research Agenda
for Manufacturing. All comments
received were reviewed and addressed
where appropriate.
DATES:

John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2018–01906 Filed 1–30–18; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60–day–18–18KG; Docket No. CDC–2018–
0013]

[FR Doc. 2018–01814 Filed 1–30–18; 8:45 am]
BILLING CODE 4160–90–P

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Information Collection for U.S.
Tuberculosis Follow-up Worksheet for
Newly-Arrived Persons with Overseas
Tuberculosis Classifications—CDC is
proposing a TB follow-up worksheet to
capture domestic TB examination data
for persons arriving to the U.S. with
overseas TB classifications.
DATES: CDC must receive written
comments on or before April 2, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0013 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE, MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road, NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
SUMMARY:

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Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Information Collection for U.S.
Tuberculosis Follow-up Worksheet for
Newly-Arrived Persons with Overseas
Tuberculosis Classifications—Existing
Information Collection in Use Without
an OMB Control Number—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC highly recommends that persons
with overseas classification A or B for
TB receive U.S. follow-up evaluations to
prevent new transmission of TB. This
information will assist CDC in fulfilling

activities, both international and
domestic in nature.
The U.S. foreign born population had
the highest incidence of TB compared to
the U.S. non-foreign born population.
CDC strongly recommends incoming
persons receive follow-up examinations
for TB in the U.S. This data collection
will facilitate the methodical collection
of TB follow-up outcome data to
monitor and track persons with overseas
classification A and B for TB and will
assist in the national effort to prevent
new transmission of TB. To accurately
determine rates of TB, recent U.S.
arrivals receive domestic follow-up
evaluations. U.S. health departments
will provide domestic follow-up
outcome information to CDC. Without
this data, DGMQ will not have a method
of tracking and monitoring newly
arrived persons with overseas
classification A or B for TB. DGMQ will
use information reported on the
worksheet to ensure that TB programs
are effectively tracking new foreign
arrivals and coordinating follow-up
evaluations with local clinicians. To
monitor and evaluate domestic TB
program performance, CDC needs to
collect data on all elements of TB
domestic follow-up up evaluations
including CXR, diagnosis, and U.S.
treatment outcomes.
The Division of Global Migration and
Quarantine (DGMQ) staff along with
other federal partners will also use this
information to evaluate overseas panel
physician performance and overseas
prevention activities. To evaluate panel
physician performance and overseas TB
prevention activities, CDC needs to
know the results of domestic chest x-ray
(CXR), CXR comparison sputum smear
and culture, and TB diagnosis along
with domestic reviews of overseas
treatment.
There are no costs to respondents
except their time to complete the
questionnaires. The annualized burden
for this data collection is 2,200 hours.

its regulatory responsibility to prevent
the importation and spread of
communicable diseases from foreign
countries (42 CFR part 71) and interstate
control of communicable diseases in
humans (42 CFR part 70).
Section 361 of the Public Health
Service (PHS) Act (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services to make and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable disease from foreign
countries into the United States. Under
its delegated authority in 42 CFR parts
70 and 71, the Division of Global
Migration and Quarantine (DGMQ)
works to fulfill this responsibility
through numerous activities that
include monitoring the arrival of
persons with Class A and Class B
tuberculosis (TB) conditions and
coordinating domestic follow-up
examinations to prevent new
transmission of TB in the United States.
The Secretary of Health and Human
Services also has the legal authority to
establish regulations outlining the
requirements for the medical
examination of aliens before they may
be admitted into the United States. This
authority is provided under Section
212(a)(1)(A) of the Immigration and
Nationality Act (8 U.S.C. 1182(a)(1)(A))
and Section 325 of the Public Health
Service Act 42 U.S.C. 252. These
regulations are codified in 42 CFR part
34, which establish requirements that
determine whether aliens can be
admitted into the United States, which
includes health examinations when
aliens attempt to adjust status to lawful
permanent residents.
The TB follow-up worksheet is
designed to capture U.S. TB
examination data for newly arriving
persons to the U.S. with overseas
classification A and B for TB. The
information collected by the TB followup worksheet will provide a method of
performing several TB prevention

sradovich on DSK3GMQ082PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
(in hours)

Type of respondents

Form name

EDN data entry staff at state and
local health departments.

U.S. Tuberculosis Follow-up Worksheet for Newly-Arrived Persons
with Overseas Tuberculosis Classifications.

550

48

5/60

2,200

Total ...........................................

..........................................................

........................

........................

........................

2,200

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Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–01805 Filed 1–30–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2015–E–2570; FDA–
2015–E–2577]

Determination of Regulatory Review
Period for Purposes of Patent
Extension; SAPIEN XT
TRANSCATHETER HEART VALVE
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SAPIEN XT TRANSCATHETER
HEART VALVE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 2, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
July 30, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 2, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 2, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.

sradovich on DSK3GMQ082PROD with NOTICES

SUMMARY:

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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
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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 Nos. FDA–
2015–E–2570 and FDA–2015–E–2577
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; SAPIEN XT
TRANSCATHETER HEART VALVE.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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

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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 Dockets Management
Staff . 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:

Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.

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