Agency Information Collection Request. 60-Day Public Comment Request, 51280-51281 [2015-20848]
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51280
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
In row 1 of table 1 we estimate the
total annual hourly burden necessary to
comply with the requirement under
section 403(y) of the FD&C Act to be
1,112 hours. Using historical A.C.
Nielson Sales Scanner Data, we estimate
the number of dietary supplement stock
keeping units for which product sales
are greater than zero to be 55,600.
Assuming that the flow of new products
is 10 percent per year, then each year
approximately 5,560 new dietary
supplement products are projected to
enter the market. Estimating that there
are 1,700 dietary supplement
manufacturers, re-packagers, re-labelers,
and holders of dietary supplements
subject to the information collection
requirement (using the figure 1,460 as
provided in our final rule of June 25,
2007 (72 FR 34752), on the ‘‘Current
Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements,’’ and factoring for a 2
percent annual growth rate), we
calculate an annual disclosure burden of
3.27 disclosures (labels) per firm. Last,
we expect that firms prepare the
required labeling for their products in a
manner that takes into account at one
time all information required to be
disclosed and therefore believe that less
than 0.2 hours (12 minutes) per product
label would be expended to fulfill this
requirement.
In row 2 of table 1 we estimate the
total burden associated with the
recommendation to include an
explanatory statement on dietary
supplement product labels letting
consumers know the purpose of the
domestic address or telephone number
to be 1,112 hours. Based upon our
knowledge of food and dietary
supplement labeling, we estimate it
would require less than 0.2 hours (12
minutes) per product label to include
such a statement.
Notice; correction.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in theFederal
Register of Monday, August 3, 2015 (80
FR 45999). The document announced a
public workshop entitled ‘‘Surrogate
Endpoints for Clinical Trials in Kidney
Transplantation.’’ The document was
published without the email address
and fax number in the Contact Person
section and without the option for email
or phone registration in the Registration
section. This document corrects those
errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ramou Pratt, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6193, Silver Spring,
MD 20993–0002, 301–796–3928 or 301–
796–1600, FAX: 301–595–7993,
endpoints@fda.hhs.gov.
In FR Doc.
2015–18911, appearing on page 45999
in the Federal Register of Monday,
August 3, 2015, the following
corrections are made:
1. On page 45999, in the first column,
the Contact Person section is corrected
to read: ‘‘Contact Person: Ramou Pratt,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6193, Silver Spring,
MD 20993–0002, 301–796–3928 or 301–
796–1600, FAX: 301–595–7993,
endpoints@fda.hhs.gov.’’
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
2. On page 45999, in the second
column, the Registration section is
corrected to read: ‘‘Registration: Email,
fax, or phone your registration
information (including name, title, firm
name, address, telephone and fax
numbers) to Ramou Pratt (see Contact
Person) by September 25, 2015.
Registration is free for the public
workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space-available basis beginning at 8 a.m.
If you need special accommodations
because of a disability, please contact
Ramou Pratt (see Contact Person) at
least 7 days in advance.’’
Surrogate Endpoints for Clinical Trials
in Kidney Transplantation; Notice of
Public Workshop; Correction
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20760 Filed 8–21–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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ACTION:
[FR Doc. 2015–20832 Filed 8–21–15; 8:45 am]
AGENCY:
Food and Drug Administration,
HHS.
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[Document Identifier: OS–0990–0302–60D]
Agency Information Collection
Request. 60-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
Agency Information Collection Request.
60-Day Public Comment Request
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
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,
and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above email address within 60days.
Proposed Project: Medical Reserve
Corps Unit Profile and Reports
(Revision)—OMB No. 0990–0302—
Office of the Secretary/Office of the
Assistant Secretary for Health/Office of
the Surgeon General/Division of
Civilian Volunteer Medical Reserve
Corps (OS/OASH/OSG/DCVMRC) is
changed to Office of the Secretary/Office
of the Assistant Secretary for
Preparedness and Response/Office of
Emergency Management/Division of the
Civilian Volunteer Medical Reserve
Corps this reorganization was effective
as of 26 November 2014 as published in
the Federal Register [FR Doc. 2014–
28030 Filed 11–25–14; 8:45am].
Abstract: Medical Reserve Corps units
are currently located in almost 1,000
communities across the United States,
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51281
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
and represent a resource of more than
205,000 volunteers. In order to continue
supporting the MRC units in
communities across the United States,
and to continue planning for future
emergencies that are national in scope,
detailed information about the MRC
units, including unit demographics,
contact information (regular and
emergency), volunteer numbers, and
information about activities is needed
by the Division of Civilian Volunteer
Medical Reserve Corps (DCVMRC). MRC
Unit Leaders are asked to update this
information on the MRC Web site at
least quarterly, and to participate in a
Technical Assistance Assessment at
least annually. The MRC unit data
collected has expanded to include a
self-assessment tool for use by unit
leaders to aid in developing their MRC
unit. This OMB revision request is for
3 years.
ESTIMATED ANNUALIZED BURDEN TABLE
Type of
respondent
Collection tool
Unit Profile ........................................
TA Assessment .................................
Factors for Success ..........................
Unit Activity Reporting ......................
Total ...........................................
MRC
MRC
MRC
MRC
Unit
Unit
Unit
Unit
4
1
4
4
30/60
1
30/60
15/60
2,000
1,000
2,000
1,000
...........................................................
........................
........................
........................
6,000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice To Propose the Redesignation
of the Service Delivery Area for the
Wampanoag Tribe of Gay Head
(Aquinnah)
Indian Health Service, HHS.
Notice.
AGENCY:
This notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Service Delivery Area
for the Wampanoag Tribe of Gay Head
(Aquinnah) of Massachusetts. The
Aquinnah service delivery area is
currently comprised of members of the
Tribe residing in Martha’s Vineyard,
Dukes County in the State of
Massachusetts.
The Bureau of Indian Affairs (BIA)
recognized the Wampanoag Tribe of Gay
Head on February 10, 1987. Martha’s
Vineyard, Dukes County was designated
as the Aquinnah service delivery area in
the Wampanoag Tribal Council of Gay
Head, Inc., Indian Claims Settlement
Act of 1987, Public Law 100–95.
DATES: Comments must be submitted
September 23, 2015.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile (FAX)
transmission. You may submit
comments in one of four ways (please
choose only one of the ways listed):
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SUMMARY:
VerDate Sep<11>2014
16:48 Aug 21, 2015
Total burden
hours
1,000
1,000
1,000
1,000
[FR Doc. 2015–20848 Filed 8–21–15; 8:45 am]
ACTION:
Average
burden hours
per response
.............................
.............................
.............................
.............................
Terry S. Clark,
Asst Information Collection Clearance
Officer.
Jkt 235001
Leader
Leader
Leader
Leader
Number of
responses per
respondent
Number of
respondents
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a Comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Betty Gould, Regulations
Officer, Indian Health Service, 801
Thompson Avenue, TMP STE 450,
Rockville, Maryland 20852.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
above address.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above. If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with a staff member.
Comments will be made available for
public inspection at the Rockville
address from 8:30 a.m. to 5:00 p.m.,
Monday–Friday, two weeks after
publication of this notice.
FOR FURTHER INFORMATION CONTACT: Carl
Harper, Director, Office of Resource
Access and Partnerships, Indian Health
Service, 801 Thompson Avenue, Suite
360, Rockville, Maryland 20852.
Telephone 301/443–2694 (This is not a
toll free number).
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment.
Background: The IHS currently
provides services under regulations
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codified at 42 CFR part 136, subparts A
through C. Subpart C defines a Contract
Health Service Delivery Area (CHSDA),
now known as a Purchased/Referred
Care (PRC) Service Delivery Area, as the
geographic area within which PRC will
be made available by the IHS to
members of an identified Indian
community who reside in the area.
Residence in a PRC service delivery area
by a person who is within the scope of
the Indian health program, as set forth
in 42 CFR 136.12, creates no legal
entitlement to PRC but only potential
eligibility for services. Services needed
but not available at an IHS/Tribal
facility are provided under the PRC
program depending on the availability
of funds, the person’s relative medical
priority, and the actual availability and
accessibility of alternate resources in
accordance with the regulations.
As applicable to the Tribes, these
regulations provide that, unless
otherwise designated, a PRC service
delivery area shall consist of a county
which includes all or part of a
reservation and any county or counties
which have a common boundary with
the reservation. (42 CFR 136.22(a)(6)
(2014)). The regulations also provide
that after consultation with the Tribal
governing body or bodies on those
reservations included within the PRC
service delivery area, the Secretary may
from time to time, redesignate areas
within the United States for inclusion in
or exclusion from a PRC service delivery
area. The regulations require that certain
criteria must be considered before any
redesignation is made. The criteria are
as follows:
(1) The number of Indians residing in
the area proposed to be so included or
excluded;
(2) Whether the Tribal governing body
has determined that Indians residing in
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]]>Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51280-51281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20848]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0302-60D]
Agency Information Collection Request. 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request 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,
and OS document identifier, to Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above email
address within 60-days.
Proposed Project: Medical Reserve Corps Unit Profile and Reports
(Revision)--OMB No. 0990-0302--Office of the Secretary/Office of the
Assistant Secretary for Health/Office of the Surgeon General/Division
of Civilian Volunteer Medical Reserve Corps (OS/OASH/OSG/DCVMRC) is
changed to Office of the Secretary/Office of the Assistant Secretary
for Preparedness and Response/Office of Emergency Management/Division
of the Civilian Volunteer Medical Reserve Corps this reorganization was
effective as of 26 November 2014 as published in the Federal Register
[FR Doc. 2014-28030 Filed 11-25-14; 8:45am].
Abstract: Medical Reserve Corps units are currently located in
almost 1,000 communities across the United States,
[[Page 51281]]
and represent a resource of more than 205,000 volunteers. In order to
continue supporting the MRC units in communities across the United
States, and to continue planning for future emergencies that are
national in scope, detailed information about the MRC units, including
unit demographics, contact information (regular and emergency),
volunteer numbers, and information about activities is needed by the
Division of Civilian Volunteer Medical Reserve Corps (DCVMRC). MRC Unit
Leaders are asked to update this information on the MRC Web site at
least quarterly, and to participate in a Technical Assistance
Assessment at least annually. The MRC unit data collected has expanded
to include a self-assessment tool for use by unit leaders to aid in
developing their MRC unit. This OMB revision request is for 3 years.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Collection tool Type of Number of responses per hours per Total burden
respondent respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Unit Profile.................. MRC Unit Leader. 1,000 4 30/60 2,000
TA Assessment................. MRC Unit Leader. 1,000 1 1 1,000
Factors for Success........... MRC Unit Leader. 1,000 4 30/60 2,000
Unit Activity Reporting....... MRC Unit Leader. 1,000 4 15/60 1,000
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 6,000
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-20848 Filed 8-21-15; 8:45 am]
BILLING CODE 4150-47-P
