60-day FRN

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
application (NDA) 201656
(desmopressin), 0.75 mcg/0.1 mL and
1.5 mcg/0.1 mL nasal spray, submitted
by Serenity Pharmaceuticals, LLC, for
the proposed treatment of adult onset
nocturia.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at http://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 4, 2016.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
September 26, 2016. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by September 27, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Kalyani Bhatt
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
http://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/

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ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–14418 Filed 6–17–16; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR must be
received no later than August 19, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Maternal, Infant, and Early Childhood
Home Visiting Program Cost Reporting
Pilot Study.
OMB No.: 0906–xxxx—New.
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting Program
SUMMARY:

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(Federal Home Visiting Program),
administered by HRSA in partnership
with the Administration for Children
and Families, supports voluntary,
evidence-based home visiting services
during pregnancy and to parents with
young children up to kindergarten
entry. States, Tribal entities, and certain
nonprofit organizations are eligible to
receive funding from the Federal Home
Visiting Program and have the flexibility
to tailor the program to serve the
specific needs of their communities.
Funding recipients may sub award grant
funds to organizations, otherwise
known as Local Implementing Agencies
(LIAs), in order to provide services to
eligible families in at-risk communities.
Need and Proposed Use of the
Information: This information collection
is requested to conduct a pilot study to
test the reliability of a standardized cost
reporting tool for the provision of
evidence-based home visiting services.
The information collected will be used
to: Test the reliability and feasibility of
implementing a proposed set of
standardized cost metrics and
organizational characteristics across
various contexts; estimate preliminary
total costs for implementing evidencebased home visiting services, including
ranges; and further refine cost metrics
and the cost reporting tool based on
feedback received through the pilot
study. Proposed standard cost metrics
have been developed based on a review
of the existing literature for measures of
home visiting costs, as well as from
ongoing discussions with developers of
evidence-based home visiting models.
Likely Respondents: Organizations
including LIAs providing evidencebased home visiting services through
the Federal Home Visiting Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.

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39932

Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Cost Elements Table ...........................................................
Organizational Characteristics Table ...................................

90
90

1
1

90
90

4
0.5

360
45

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

90

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

90

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

405

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection 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.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–14417 Filed 6–17–16; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[30-Day notice]

Agency Information Collection
Request. 30-Day Public Comment
Request, Grants.gov

In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995,
Grants.gov (EGOV), Department of
Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection 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.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, email your request,
including your address, phone number,
OMB number, to Ed.Calimag@hhs.gov,
or call the Reports Clearance Office on

Office of the Secretary, HHS.
Agency Information Collection
Request; 30-Day Public Comment
Request; Grants.gov.

AGENCY:

(202) 690–6162. Send written comments
and recommendations for the proposed
information collections within 30 days
of this notice directly to the Grants.gov
OMB Desk Officer; faxed to OMB at
202–395–6974.
Proposed Project
Application for Federal Assistance
Research and Related SF424 OMB No.
4040–0001.
3 Year Extension and assignment as a
Common Form.
Office: Grants.gov.
Abstract: The Application for Federal
Assistance SF–424 Research and
Related is an OMB-approved collection
(4040–0001). This information
collection is used by more than 26
Federal grant-making entities for
research and related projects. This IC
originally was to expire on June 30,
2016. The expiration date has been
extended to July 31, 2016. We are
requesting a three-year clearance of this
collection and that it be designated as a
Common Form.
Estimated Annualized Burden Table:

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

SF–424 Application for Federal Assistance—Research and Related .............
Research and Related Budget 5 Year ............................................................
Research and Related Budget 10 Year ..........................................................
SF–424 Research and Related Multi-Project Cover .......................................
Research & Related Multi-Project 10 Year Budget .........................................
R & R Multi-Project Subaward Budget Attachment(s) Form 10YR 30ATT .....
R & R Subaward Budget Attachment(s) Form ................................................
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT .........................
R & R Subaward Budget Attachment(s) Form 10 YR 30 ATT .......................
Research & Related Senior/Key Person Profile ..............................................
Research and Related Senior/Key Person Profile (Expanded) ......................
Research And Related Other Project Information ...........................................
SBIR/STTR Information ...................................................................................

137,407
121,416
1,118
1,570
1,570
1,570
217
121,088
1,118
218
136,940
137,699
21,289

1
1
1
1
1
........................
........................
1
1
1
1
1
1

1
1
1
1
1
........................
........................
1
1
1
1
1
1

137,407
121,416
1,118
1,570
1,570
1,570
217
121,088
1,118
218
136,940
137,699
21,289

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

683,220

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

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

683,220

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