80 FR 77646 - Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works-Best Practice, Promising Practice, and Local Effort (BPPPLE) Form
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Federal Register Volume 80, Issue 240 (December 15, 2015)
Indian Health Service
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77646-77647 | |
| FR Document | 2015-31534 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77646-77647] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31534] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [OMB Control Number 0917-0034] Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works--Best Practice, Promising Practice, and Local Effort (BPPPLE) Form AGENCY: Indian Health Service, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Indian Health Service published a 30 day Federal Register notice in the Federal Register (FR) on November 17, 2015 (80 FR 71813) to solicit comments from the general public on the information collection titled, ``Indian Health Service (IHS) Sharing What Works-- Best Practice, Promising Practice, and Local Effort (BPPPLE) Form,'' Office of Management and Budget (OMB) Control Number 0917-0034. The notice was submitted before the 60 day FR notice comment period for the same information collection ends on December 8, 2015. Therefore, the correct date for the deadline to submit comments regarding the 30 day FR notice is January 9, 2016. [[Page 77647]] ADDRESSES: Direct Your Comments to OMB: Send your comments and suggestions regarding the proposed information collection contained in this notice, especially regarding the estimated public burden and associated response time to: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for IHS. FOR FURTHER INFORMATION CONTACT: To request additional information, please contact Tamara Clay by one of the following methods:Mail: Tamara Clay, Information Collection Clearance Officer, Indian Health Service, Office of Management Services, Division of Regulatory Affairs, 5600 Fishers Lane, Rockville, Mail Stop 09E70, MD 20857. Phone: 301-443-4750. Email: Tamara.Clay@ihs.gov. SUPPLEMENTARY INFORMATION: Corrections In the Federal Register of November 17, in FR Doc. 2015-29251, on page 71814, in the middle column, under the heading Comment Due Date, the due date is corrected to read as January 9, 2016. Dated: December 4, 2015. Robert G. McSwain, Principal Deputy Director, Indian Health Service. [FR Doc. 2015-31534 Filed 12-14-15; 8:45 am] BILLING CODE 4165-16-P
![77646 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
Submissions,’’ publicly viewable at FOR FURTHER INFORMATION CONTACT: Appendix 6 of the 2007 Donor
http://www.regulations.gov or at the Jonathan McKnight, Center for Biologics Eligibility Guidance.
Division of Dockets Management Evaluation and Research, Food and The draft guidance is being issued
between 9 a.m. and 4 p.m., Monday Drug Administration, 10903 New consistent with FDA’s good guidance
through Friday. Hampshire Ave. Bldg. 71, Rm. 7301, practices regulation (21 CFR 10.115).
• Confidential Submissions—To Silver Spring, MD 20993–0002, 240– The draft guidance, when finalized, will
submit a comment with confidential 402–7911. represent the current thinking of FDA
information that you do not wish to be SUPPLEMENTARY INFORMATION: on ‘‘Use of Nucleic Acid Tests to
made publicly available submit your Reduce the Risk of Transmission of
comments only as a written/paper I. Background
West Nile Virus from Living Donors of
submission. You should submit two FDA is announcing the availability of Human Cells, Tissues, and Cellular and
copies total. One copy will include the a draft document entitled ‘‘Use of Tissue-Based Products (HCT/Ps); Draft
information you claim to be confidential Nucleic Acid Tests to Reduce the Risk Guidance for Industry.’’ It does not
with a heading or cover note that states of Transmission of West Nile Virus establish any rights for any person and
‘‘THIS DOCUMENT CONTAINS From Living Donors of Human Cells, is not binding on FDA or the public.
CONFIDENTIAL INFORMATION.’’ The Tissues, and Cellular and Tissue-Based You can use an alternative approach if
Agency will review this copy, including Products (HCT/Ps); Draft Guidance for it satisfies the requirements of the
the claimed confidential information, in Industry.’’ The draft guidance document applicable statutes and regulations.
its consideration of comments. The provides establishments that make
second copy, which will have the donor eligibility determinations for II. Electronic Access
claimed confidential information donors of HCT/Ps with Persons with access to the Internet
redacted/blacked out, will be available recommendations for testing living may obtain the draft guidance at either
for public viewing and posted on donors for WNV. The draft guidance http://www.fda.gov/Biologics
http://www.regulations.gov. Submit recommends an FDA-licensed NAT to BloodVaccines/Guidance
both copies to the Division of Dockets test living donors of HCT/Ps for ComplianceRegulatoryInformation/
Management. If you do not wish your evidence of infection with WNV. The Guidances/default.htm or http://
name and contact information to be guidance does not provide www.regulations.gov.
made publicly available, you can recommendations regarding testing of
Dated: December 8, 2015.
provide this information on the cover cadaveric HCT/P donors for WNV. FDA
sheet and not in the body of your believes that the use of an FDA-licensed Leslie Kux,
comments and you must identify this NAT will reduce the risk of Associate Commissioner for Policy.
information as ‘‘confidential.’’ Any transmission of WNV from living donors [FR Doc. 2015–31405 Filed 12–14–15; 8:45 am]
information marked as ‘‘confidential’’ of HCT/Ps and therefore recommends BILLING CODE 4164–01–P
will not be disclosed except in that you use an FDA-licensed NAT for
accordance with 21 CFR 10.20 and other testing living donors of HCT/Ps for
applicable disclosure law. For more infection with WNV. The 2007 Donor DEPARTMENT OF HEALTH AND
information about FDA’s posting of Eligibility Guidance indicated that FDA HUMAN SERVICES
comments to public dockets, see 80 FR may recommend routine use of an
56469, September 18, 2015, or access appropriate, licensed donor screening Indian Health Service
the information at: http://www.fda.gov/ test(s) to detect acute infections with [OMB Control Number 0917–0034]
regulatoryinformation/dockets/default. WNV using NAT technology, once such
htm. tests were available. Request for Public Comment: 30-Day
Docket: For access to the docket to In the Federal Register of October 24, Proposed Information Collection:
read background documents or the 2013 (78 FR 63476), FDA announced the Indian Health Service (IHS) Sharing
electronic and written/paper comments availability of the draft guidance What Works—Best Practice, Promising
received, go to http:// entitled ‘‘Draft Guidance for Industry: Practice, and Local Effort (BPPPLE)
www.regulations.gov and insert the Use of Nucleic Acid Tests to Reduce the Form
docket number, found in brackets in the Risk of Transmission of West Nile Virus
heading of this document, into the from Donors of Human Cells, Tissues, AGENCY: Indian Health Service, HHS.
‘‘Search’’ box and follow the prompts and Cellular and Tissue-Based Products ACTION: Notice; correction.
and/or go to the Division of Dockets (HCT/Ps)’’ dated October 2013 (October
Management, 5630 Fishers Lane, Rm. 2013 draft guidance). FDA received SUMMARY: The Indian Health Service
1061, Rockville, MD 20852. several comments on the draft guidance published a 30 day Federal Register
Submit written requests for single and those comments were considered as notice in the Federal Register (FR) on
copies of the draft guidance to the Office this draft guidance was developed. November 17, 2015 (80 FR 71813) to
of Communication, Outreach and In the Federal Register of February solicit comments from the general
Development, Center for Biologics 28, 2007 (72 FR 9007), FDA announced public on the information collection
Evaluation and Research (CBER), Food the availability of the 2007 Donor titled, ‘‘Indian Health Service (IHS)
and Drug Administration, 10903 New Eligibility Guidance. FDA issued a Sharing What Works—Best Practice,
Hampshire Ave. Bldg. 71, Rm. 3128, revised version of this guidance under Promising Practice, and Local Effort
Silver Spring, MD 20993–0002. Send the same title, dated August 2007 (2007 (BPPPLE) Form,’’ Office of Management
asabaliauskas on DSK5VPTVN1PROD with NOTICES
one self-addressed adhesive label to Donor Eligibility Guidance). and Budget (OMB) Control Number
assist the office in processing your The draft guidance announced in this 0917–0034. The notice was submitted
requests. The draft guidance may also be notice replaces the October 2013 draft before the 60 day FR notice comment
obtained by mail by calling CBER at 1– guidance and when finalized, will period for the same information
800–835–4709 or 240–402–8010. See supplement sections IV.E. collection ends on December 8, 2015.
the SUPPLEMENTARY INFORMATION section (recommendations 15 and 16), IV.F. Therefore, the correct date for the
for electronic access to the draft (recommendation 5), and supersede the deadline to submit comments regarding
guidance document. ‘‘West Nile Virus (WNV)’’ section in the 30 day FR notice is January 9, 2016.
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![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77647
ADDRESSES: Direct Your Comments to Implementation Cooperative Agreement Name of Committee: National Institute of
OMB: Send your comments and (U01). Allergy and Infectious Diseases Special
suggestions regarding the proposed Date: January 22, 2016. Emphasis Panel.
Time: 10:00 a.m. to 1:00 p.m. Date: January 28, 2016.
information collection contained in this Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
notice, especially regarding the applications. Agenda: To review and evaluate grant
estimated public burden and associated Place: National Institutes of Health, 5601 applications.
response time to: Office of Management Fishers Lane, Rockville, MD 20892, Place: National Institutes of Health, Room
and Budget, Office of Regulatory Affairs, (Telephone Conference Call). 4H100, 5601 Fishers Lane, Rockville, MD
New Executive Office Building, Room Contact Person: Paul A. Amstad, Ph.D., 20892, (Virtual Meeting).
10235, Washington, DC 20503, Scientific Review Officer, Scientific Review Contact Person: Amir Emanuel Zeituni,
Program, Division of Extramural Activities, Ph.D., Scientific Review Program, DEA/
Attention: Desk Officer for IHS.
Room 3G41, NIAID/NIH/DHHS, 5601 Fishers NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–
FOR FURTHER INFORMATION CONTACT: To 9834, Rockville, MD 20852, 301–496–2550.
Lane, Bethesda, MD 20892–7616, 240–669–
request additional information, please 5067, pamstad@niaid.nih.gov. (Catalogue of Federal Domestic Assistance
contact Tamara Clay by one of the Program Nos. 93.855, Allergy, Immunology,
Name of Committee: National Institute of
following methods: Allergy and Infectious Diseases Special and Transplantation Research; 93.856,
• Mail: Tamara Clay, Information Emphasis Panel, NIAID Investigator Initiated Microbiology and Infectious Diseases
Collection Clearance Officer, Indian Program Project Applications (P01). Research, National Institutes of Health, HHS)
Health Service, Office of Management Date: January 22, 2016. Dated: December 9, 2015.
Services, Division of Regulatory Affairs, Time: 1:00 p.m. to 5:00 p.m. Natasha M. Copeland,
5600 Fishers Lane, Rockville, Mail Stop Agenda: To review and evaluate grant
applications. Program Analyst, Office of Federal Advisory
09E70, MD 20857. Committee Policy.
• Phone: 301–443–4750. Place: National Institutes of Health, 5601
• Email: Tamara.Clay@ihs.gov. Fishers Lane, Rockville, MD 20892, [FR Doc. 2015–31435 Filed 12–14–15; 8:45 am]
SUPPLEMENTARY INFORMATION: (Telephone Conference Call). BILLING CODE 4140–01–P
Contact Person: Paul A. Amstad, Ph.D.,
Corrections Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities, DEPARTMENT OF HEALTH AND
In the Federal Register of November Room 3G41, NIAID/NIH/DHHS, 5601 Fishers
17, in FR Doc. 2015–29251, on page HUMAN SERVICES
Lane, Bethesda, MD 20892–7616, 240–669–
71814, in the middle column, under the 5067, pamstad@niaid.nih.gov. National Institutes of Health
heading Comment Due Date, the due
(Catalogue of Federal Domestic Assistance
date is corrected to read as January 9, Program Nos. 93.855, Allergy, Immunology, Proposed Collection; 60-Day Comment
2016. and Transplantation Research; 93.856, Request; The Impact of Clinical
Dated: December 4, 2015. Microbiology and Infectious Diseases Research Training and Medical
Robert G. McSwain, Research, National Institutes of Health, HHS) Education at the Clinical Center on
Principal Deputy Director, Indian Health Dated: December 9, 2015. Physician Careers in Academia and
Service. Natasha M. Copeland, Clinical Research (CC)
[FR Doc. 2015–31534 Filed 12–14–15; 8:45 am] Program Analyst, Office of Federal Advisory SUMMARY: In compliance with the
BILLING CODE 4165–16–P Committee Policy. requirement of Section 3506(c)(2)(A) of
[FR Doc. 2015–31434 Filed 12–14–15; 8:45 am] the Paperwork Reduction Act of 1995,
BILLING CODE 4140–01–P for opportunity for public comment on
DEPARTMENT OF HEALTH AND proposed data collection projects, the
HUMAN SERVICES Clinical Center, the National Institutes
DEPARTMENT OF HEALTH AND of Health (NIH) will publish periodic
National Institutes of Health HUMAN SERVICES summaries of proposed projects to be
National Institute of Allergy and submitted to the Office of Management
National Institutes of Health and Budget (OMB) for review and
Infectious Diseases; Notice of Closed
Meetings approval.
National Institute of Allergy and To Submit Comments and for Further
Pursuant to section 10(d) of the Infectious Diseases; Notice of Closed Information: Written comments and/or
Federal Advisory Committee Act, as Meeting suggestions from the public and affected
amended (5 U.S.C. App.), notice is agencies should address one or more of
hereby given of the following meetings. Pursuant to section 10(d) of the the following points: (1) Evaluate
The meetings will be closed to the Federal Advisory Committee Act, as whether the proposed collection of
public in accordance with the amended (5 U.S.C. App.), notice is information is necessary for the proper
provisions set forth in sections hereby given of the following meeting. performance of the function of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will be closed to the agency, including whether the
as amended. The grant applications and public in accordance with the information will have practical utility;
the discussions could disclose provisions set forth in sections (2) Evaluate the accuracy of the agency’s
confidential trade secrets or commercial 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., estimate of the burden of the proposed
property such as patentable material, as amended. The grant applications and collection of information, including the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
and personal information concerning the discussions could disclose validity of the methodology and
individuals associated with the grant confidential trade secrets or commercial assumptions used; (3) Enhance the
applications, the disclosure of which property such as patentable material, quality, utility, and clarity of the
would constitute a clearly unwarranted and personal information concerning information to be collected; and (4)
invasion of personal privacy. individuals associated with the grant Minimize the burden of the collection of
Name of Committee: National Institute of applications, the disclosure of which information on those who are to
Allergy and Infectious Diseases Special would constitute a clearly unwarranted respond, including the use of
Emphasis Panel, NIAID Clinical Trial invasion of personal privacy. appropriate automated, electronic,
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Document Created: 2018-03-02 09:16:19
Document Modified: 2018-03-02 09:16:19
| 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 | |
| Action | Notice; correction. | |
| Contact | To request additional information, please contact Tamara Clay by one of the following methods: | |
| FR Citation | 80 FR 77646 |
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