80 FR 51280 - Agency Information Collection Request. 60-Day Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 163 (August 24, 2015)
Federal Register Volume 80, Issue 163 (August 24, 2015)
| Page Range | 51280-51281 | |
| FR Document | 2015-20848 |
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)] [Notices] [Pages 51280-51281] From the Federal Register Online [www.thefederalregister.org] [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
![51280 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
In row 1 of table 1 we estimate the ACTION: Notice; correction. DEPARTMENT OF HEALTH AND
total annual hourly burden necessary to HUMAN SERVICES
comply with the requirement under SUMMARY: The Food and Drug [Document Identifier: OS–0990–0302–60D]
section 403(y) of the FD&C Act to be Administration (FDA) is correcting a
1,112 hours. Using historical A.C. notice that appeared in theFederal Agency Information Collection
Nielson Sales Scanner Data, we estimate Register of Monday, August 3, 2015 (80 Request. 60-Day Public Comment
the number of dietary supplement stock FR 45999). The document announced a Request
keeping units for which product sales public workshop entitled ‘‘Surrogate
are greater than zero to be 55,600. AGENCY: Office of the Secretary, HHS.
Endpoints for Clinical Trials in Kidney
Assuming that the flow of new products Transplantation.’’ The document was Agency Information Collection Request.
is 10 percent per year, then each year 60-Day Public Comment Request
published without the email address
approximately 5,560 new dietary
and fax number in the Contact Person In compliance with the requirement
supplement products are projected to
section and without the option for email of section 3506(c)(2)(A) of the
enter the market. Estimating that there
are 1,700 dietary supplement or phone registration in the Registration Paperwork Reduction Act of 1995, the
manufacturers, re-packagers, re-labelers, section. This document corrects those Office of the Secretary (OS), Department
and holders of dietary supplements errors. of Health and Human Services, is
subject to the information collection publishing the following summary of a
FOR FURTHER INFORMATION CONTACT: proposed information collection request
requirement (using the figure 1,460 as Ramou Pratt, Center for Drug Evaluation for public comment. Interested persons
provided in our final rule of June 25,
and Research, Food and Drug are invited to send comments regarding
2007 (72 FR 34752), on the ‘‘Current
Administration, 10903 New Hampshire this burden estimate or any other aspect
Good Manufacturing Practice in
Ave., Bldg. 22, Rm. 6193, Silver Spring, of this collection of information,
Manufacturing, Packaging, Labeling, or
MD 20993–0002, 301–796–3928 or 301– including any of the following subjects:
Holding Operations for Dietary
796–1600, FAX: 301–595–7993, (1) The necessity and utility of the
Supplements,’’ and factoring for a 2
endpoints@fda.hhs.gov. proposed information collection for the
percent annual growth rate), we
proper performance of the agency’s
calculate an annual disclosure burden of SUPPLEMENTARY INFORMATION: In FR Doc. functions; (2) the accuracy of the
3.27 disclosures (labels) per firm. Last, 2015–18911, appearing on page 45999 estimated burden; (3) ways to enhance
we expect that firms prepare the in the Federal Register of Monday, the quality, utility, and clarity of the
required labeling for their products in a August 3, 2015, the following information to be collected; and (4) the
manner that takes into account at one corrections are made: use of automated collection techniques
time all information required to be or other forms of information
disclosed and therefore believe that less 1. On page 45999, in the first column,
the Contact Person section is corrected technology to minimize the information
than 0.2 hours (12 minutes) per product collection burden. To obtain copies of
label would be expended to fulfill this to read: ‘‘Contact Person: Ramou Pratt,
Center for Drug Evaluation and the supporting statement and any
requirement. related forms for the proposed
In row 2 of table 1 we estimate the Research, Food and Drug
paperwork collections referenced above,
total burden associated with the Administration, 10903 New Hampshire
email your request, including your
recommendation to include an Ave., Bldg. 22, Rm. 6193, Silver Spring,
address, phone number, OMB number,
explanatory statement on dietary MD 20993–0002, 301–796–3928 or 301– and OS document identifier, to
supplement product labels letting 796–1600, FAX: 301–595–7993, Sherette.funncoleman@hhs.gov, or call
consumers know the purpose of the endpoints@fda.hhs.gov.’’ the Reports Clearance Office on (202)
domestic address or telephone number 690–6162. Written comments and
2. On page 45999, in the second
to be 1,112 hours. Based upon our recommendations for the proposed
knowledge of food and dietary column, the Registration section is
corrected to read: ‘‘Registration: Email, information collections must be directed
supplement labeling, we estimate it to the OS Paperwork Clearance Officer
would require less than 0.2 hours (12 fax, or phone your registration
information (including name, title, firm at the above email address within 60-
minutes) per product label to include days.
such a statement. name, address, telephone and fax
Proposed Project: Medical Reserve
numbers) to Ramou Pratt (see Contact
Dated: August 17, 2015. Corps Unit Profile and Reports
Person) by September 25, 2015.
Leslie Kux, (Revision)—OMB No. 0990–0302—
Registration is free for the public Office of the Secretary/Office of the
Associate Commissioner for Policy. workshop. Early registration is
[FR Doc. 2015–20760 Filed 8–21–15; 8:45 am] Assistant Secretary for Health/Office of
recommended because seating is the Surgeon General/Division of
BILLING CODE 4164–01–P limited. Registration on the day of the Civilian Volunteer Medical Reserve
public workshop will be provided on a Corps (OS/OASH/OSG/DCVMRC) is
space-available basis beginning at 8 a.m. changed to Office of the Secretary/Office
DEPARTMENT OF HEALTH AND
HUMAN SERVICES If you need special accommodations of the Assistant Secretary for
because of a disability, please contact Preparedness and Response/Office of
Food and Drug Administration Ramou Pratt (see Contact Person) at Emergency Management/Division of the
least 7 days in advance.’’ Civilian Volunteer Medical Reserve
[Docket No. FDA–2015–N–0001]
tkelley on DSK3SPTVN1PROD with NOTICES
Corps this reorganization was effective
Dated: August 19, 2015.
Surrogate Endpoints for Clinical Trials as of 26 November 2014 as published in
Leslie Kux, the Federal Register [FR Doc. 2014–
in Kidney Transplantation; Notice of
Public Workshop; Correction Associate Commissioner for Policy. 28030 Filed 11–25–14; 8:45am].
[FR Doc. 2015–20832 Filed 8–21–15; 8:45 am] Abstract: Medical Reserve Corps units
AGENCY: Food and Drug Administration, BILLING CODE 4164–01–P
are currently located in almost 1,000
HHS. communities across the United States,
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![Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices 51281
and represent a resource of more than contact information (regular and Technical Assistance Assessment at
205,000 volunteers. In order to continue emergency), volunteer numbers, and least annually. The MRC unit data
supporting the MRC units in information about activities is needed collected has expanded to include a
communities across the United States, by the Division of Civilian Volunteer self-assessment tool for use by unit
and to continue planning for future Medical Reserve Corps (DCVMRC). MRC leaders to aid in developing their MRC
emergencies that are national in scope, Unit Leaders are asked to update this unit. This OMB revision request is for
detailed information about the MRC information on the MRC Web site at 3 years.
units, including unit demographics, least quarterly, and to participate in a
ESTIMATED ANNUALIZED BURDEN TABLE
Number of Average
Type of Number of Total burden
Collection tool responses per burden hours
respondent respondents hours
respondent per response
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, 1. Electronically. You may submit codified at 42 CFR part 136, subparts A
Asst Information Collection Clearance electronic comments on this regulation through C. Subpart C defines a Contract
Officer. to http://www.regulations.gov. Follow Health Service Delivery Area (CHSDA),
[FR Doc. 2015–20848 Filed 8–21–15; 8:45 am] the ‘‘Submit a Comment’’ instructions. now known as a Purchased/Referred
BILLING CODE 4150–47–P 2. By regular mail. You may mail Care (PRC) Service Delivery Area, as the
written comments to the following geographic area within which PRC will
address ONLY: Betty Gould, Regulations be made available by the IHS to
DEPARTMENT OF HEALTH AND Officer, Indian Health Service, 801 members of an identified Indian
HUMAN SERVICES Thompson Avenue, TMP STE 450, community who reside in the area.
Rockville, Maryland 20852. Residence in a PRC service delivery area
Indian Health Service Please allow sufficient time for mailed by a person who is within the scope of
comments to be received before the the Indian health program, as set forth
Notice To Propose the Redesignation close of the comment period. in 42 CFR 136.12, creates no legal
of the Service Delivery Area for the 3. By express or overnight mail. You entitlement to PRC but only potential
Wampanoag Tribe of Gay Head may send written comments to the eligibility for services. Services needed
(Aquinnah) above address. but not available at an IHS/Tribal
4. By hand or courier. If you prefer, facility are provided under the PRC
AGENCY: Indian Health Service, HHS. you may deliver (by hand or courier) program depending on the availability
ACTION: Notice. your written comments before the close of funds, the person’s relative medical
of the comment period to the address priority, and the actual availability and
SUMMARY: This notice advises the public above. If you intend to deliver your
that the Indian Health Service (IHS) accessibility of alternate resources in
comments to the Rockville address, accordance with the regulations.
proposes to expand the geographic please call telephone number (301) 443–
boundaries of the Service Delivery Area As applicable to the Tribes, these
1116 in advance to schedule your regulations provide that, unless
for the Wampanoag Tribe of Gay Head arrival with a staff member.
(Aquinnah) of Massachusetts. The otherwise designated, a PRC service
Comments will be made available for delivery area shall consist of a county
Aquinnah service delivery area is public inspection at the Rockville
currently comprised of members of the which includes all or part of a
address from 8:30 a.m. to 5:00 p.m., reservation and any county or counties
Tribe residing in Martha’s Vineyard, Monday–Friday, two weeks after
Dukes County in the State of which have a common boundary with
publication of this notice. the reservation. (42 CFR 136.22(a)(6)
Massachusetts. FOR FURTHER INFORMATION CONTACT: Carl
The Bureau of Indian Affairs (BIA) (2014)). The regulations also provide
Harper, Director, Office of Resource that after consultation with the Tribal
recognized the Wampanoag Tribe of Gay Access and Partnerships, Indian Health
Head on February 10, 1987. Martha’s governing body or bodies on those
Service, 801 Thompson Avenue, Suite reservations included within the PRC
Vineyard, Dukes County was designated 360, Rockville, Maryland 20852.
as the Aquinnah service delivery area in service delivery area, the Secretary may
Telephone 301/443–2694 (This is not a from time to time, redesignate areas
the Wampanoag Tribal Council of Gay toll free number).
Head, Inc., Indian Claims Settlement within the United States for inclusion in
SUPPLEMENTARY INFORMATION: Inspection or exclusion from a PRC service delivery
Act of 1987, Public Law 100–95.
of Public Comments: All comments area. The regulations require that certain
DATES: Comments must be submitted received before the close of the criteria must be considered before any
September 23, 2015.
tkelley on DSK3SPTVN1PROD with NOTICES
comment period are available for redesignation is made. The criteria are
ADDRESSES: Because of staff and viewing by the public, including any as follows:
resource limitations, we cannot accept personally identifiable or confidential (1) The number of Indians residing in
comments by facsimile (FAX) business information that is included in the area proposed to be so included or
transmission. You may submit a comment. excluded;
comments in one of four ways (please Background: The IHS currently (2) Whether the Tribal governing body
choose only one of the ways listed): provides services under regulations has determined that Indians residing in
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Document Created: 2015-12-15 10:55:02
Document Modified: 2015-12-15 10:55:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 51280 |
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