30-day Federal Register Notice (Implementation)

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Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices

qualifications of the candidate from
person(s) not employed by the U.S.
Department of Health and Human
Services. Candidates may submit
letter(s) from current HHS employees if
they wish, but at least one letter must
be submitted by a person not employed
by HHS.
Nominations should be submitted
(postmarked or received) by August 15,
2016.
Electronic submissions: You may
submit nominations, including
attachments, electronically to hicpac@
cdc.gov.
Regular, Express or Overnight Mail:
Written nominations may be submitted
to the following addressee only: Erin
Stone, M.S., HICPAC, Division of
Healthcare Quality Promotion, NCEZID,
CDC, l600 Clifton Road NE., Mailstop
A–07, Atlanta, Georgia 30333.
Telephone and facsimile submissions
cannot be accepted. Nominations may
be submitted by the candidate or by the
person/organization recommending the
candidate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–10423 Filed 5–3–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10615]

Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
ACTION: Notice.

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AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on an information collection
concerning CMS’ Healthy Indiana
Program (HIP) 2.0 Beneficiaries Survey.
We are also announcing that the
proposed information collection had

SUMMARY:

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been submitted to OMB and was
approved under control number 0938–
1300 through September 30, 2016. In
accordance with the implementing
regulations of the Paperwork Reduction
Act of 1995 (PRA) we requested
emergency review under 5 CFR
1320.13(a)(2)(i) because public harm is
reasonably likely to result if the regular
clearance procedures were followed.
More specifically, the regular PRA
clearance process would jeopardize the
timely completion of CMS’ evaluation of
the State’s upcoming non-emergency
medical transportation (NEMT) waiver
and other important waivers. Most
importantly, it would potentially cause
significant harm by depriving Medicaid
beneficiaries—especially those affected
by the NEMT waiver—of appropriate
medical services and needed care.
Although we have already received
OMB approval to test/develop the
survey instruments, we are now
soliciting public comment for 30-days
prior to implementing the survey in
order to meet the conditions of OMB’s
Terms of Clearance that were issued on
March 21, 2016.
Under the PRA, federal agencies are
required to publish notice in the
Federal Register concerning each
proposed information collection request
(ICR). Interested persons are invited to
send comments regarding our burden
estimates or any other aspect of this ICR,
including any of the following subjects:
(1) The necessity and utility of the
proposed ICR for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
June 3, 2016.
ADDRESSES: When commenting, please
reference the document identifier
(CMS–10615) or OMB control number
(0938–1300). To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic

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Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: CMS–10615/OMB Control
Number 0938–1300, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
http://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:

Contents
This notice sets out a summary of the
use and burden associated with the
following ICR. More detailed
information can be found in the
collection’s supporting statement and
associated materials (see ADDRESSES).
CMS–10615 Healthy Indiana Program
(HIP) 2.0 Beneficiaries Survey
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public: Submit reports, keep records, or
provide information to a third party. In
compliance with the requirement of
section 3506(c)(2)(A) of the PRA, we
submitted to OMB our request for
emergency processing of this
information collection. OMB approved
the emergency ICR for testing/
developing the survey on March 21,
2016. This iteration seeks emergency
approval for fielding the survey and for
conducting interviews and focus groups.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Healthy Indiana
Program (HIP) 2.0 Beneficiaries Survey;
Use: This is a request for emergency
approval to field the surveys and to
conduct key informant interviews and
focus groups. The surveys were tested
during the first week of April 2016, and

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asabaliauskas on DSK3SPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices
there was a week-long public comment
period that was announced in the
Federal Register on March 29, 2016 (81
FR 17460). This ICR contains the
revised surveys based on testing and
public comments provided during the
survey testing period.
Emergency OMB approval is being
sought, as permitted under 5 CPR
1320.13(a)(2)(i), since public harm is
reasonably likely to occur if the regular
nonemergency PRA clearance
procedures are followed. Potential harm
may result due to insufficient
information to adequately support
decision making that is required in
November 2016. The clearance is
particularly important for decisions
about the renewal of precedent-setting
waivers of Medicaid policy that assure
important beneficiary protections
regarding coverage and access to care;
e.g., the NEMT waiver. That waiver
ends or will be extended by no later
than December 1, 2016. The survey
effort is critical to supply more detail
and information on HIP 2.0 beneficiary
understanding and experiences (current
and new enrollees as well as
disenrollees/lockouts). Other
information on other key policies under
the Indiana HIP 2.0 demonstration, such
as the 60 day beneficiary lock-out
period, is also included in this
information collection. Including this
other information, as well as the
interviews and focus groups, with the
NEMT related information allows all
this information to be collected during
the same period of time; this will
improve the efficiency of resources
when compared to fielding separate
surveys, interviews and focus groups at
a later time which would be needed
under the regular PRA process. Form
Number: CMS–10615 (OMB control
number: 0938–1300); Frequency: Once;
Affected Public: Individuals and
households, Private sector (Business or
other for-profits and Not-for-profits
institutions), and State, Local, or Tribal
Governments; Number of Respondents:
5,240; Total Annual Responses: 5,240;
Total Annual Hours: 1,442. (For policy
questions regarding this collection
contact Teresa DeCaro at 202–384–
6309).
Written comments and
recommendations will be considered
from the public if received by the date
and address noted above.
Dated: April 29, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–10448 Filed 5–3–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1174]

Special Protocol Assessment; Draft
Guidance for Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Special
Protocol Assessment.’’ This draft
guidance provides information about
the procedures and general policies
adopted by the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) for special protocol
assessment (SPA). This draft guidance is
intended to improve the quality of
Requests for SPAs and accompanying
submission materials, and the quality of
the resulting interaction between
sponsors and FDA. This draft guidance
revises the guidance for industry
entitled ‘‘Special Protocol Assessment’’
issued May 17, 2002.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 5, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to http://
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 http://www.regulations.gov.

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• 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): 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–1174 for ‘‘Special Protocol
Assessment; Draft Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at http://www.regulations.gov
or at the Division of Dockets
Management 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
http://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

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