Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Correction, 66967 [2016-23514]

Download as PDF Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Collection; Comment Request; University Centers for Excellence in Developmental Disabilities Education, Research, and Service—Annual Report The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), HHS. ACTION: Notice. AGENCY: The Administration on Intellectual and Developmental Disabilities (AIDD), now part of the Administration for Community Living, is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments on the collection of information by October 31, 2016. ADDRESSES: OIRA_submission@ omb.eop.gov or by fax to 202.395.5806. Attn: OMB Desk Officer for ACL, Office of Information and Regulatory Affairs, OMB. SUMMARY: mstockstill on DSK3G9T082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Ophelia McLain at 202–795–7401 orophelia.mclain@acl.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, the Administration on Intellectual and Developmental Disabilities (now part of the Administration for Community Living) has submitted the following proposed collection of information to OMB for review and clearance. Section 104 (42 U.S.C. 15004) of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000) directs the Secretary of Health and Human Services to develop and implement a system of program accountability to monitor the grantees funded under the DD Act of 2000. The program accountability system shall include the National Network of University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs) authorized under Part D of the DD Act of 2000. In addition to the accountability system, Section 154 (e) (42 U.S.C. 15064) of the DD Act of 2000 includes requirements for a UCEDD Annual Report. The proposed data collection tools may be found on the ACL/AIDD Web VerDate Sep<11>2014 18:51 Sep 28, 2016 Jkt 238001 site at: http://www.acl.gov/Programs/ AIDD/Program_Resource_Search/ Results_UCEDD.aspx. AIDD estimates the burden of this collection of information as 1,412 average burden hours per responses, for 67 UCEDDs,— Total burden is 94,604 hours per year. Dated: September 22, 2016. Edwin L. Walker, Acting Administrator. [FR Doc. 2016–23488 Filed 9–28–16; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1143] Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Correction AGENCY: Food and Drug Administration, HHS. Notice of availability; correction. ACTION: The Food and Drug Administration (FDA or Agency) is correcting a notice that appeared in the Federal Register of Tuesday, September 13, 2016 (81 FR 62910). The document announced the availability of a guidance for industry entitled ‘‘Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The document was published with incorrect information of a comment period due date. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: In the Federal Register of September 13, 2016, in FR Doc. 2016–21969, on page 62910, the following correction is made: On page 62910, in the first column under the DATES: caption, the sentence is corrected to read, ‘‘Submit either electronic or written comments on Agency guidances at any time.’’ SUMMARY: Dated: September 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–23514 Filed 9–28–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 66967 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1619] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of FDA’s regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either electronic or written comments on the collection of information by November 28, 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. • If you want to submit a comment with confidential information that you E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Page 66967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23514]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1143]


Use of Nucleic Acid Tests To Reduce the Risk of Transmission of 
West Nile Virus From Living Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Guidance for Industry; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting 
a notice that appeared in the Federal Register of Tuesday, September 
13, 2016 (81 FR 62910). The document announced the availability of a 
guidance for industry entitled ``Use of Nucleic Acid Tests to Reduce 
the Risk of Transmission of West Nile Virus from Living Donors of Human 
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The 
document was published with incorrect information of a comment period 
due date. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 13, 
2016, in FR Doc. 2016-21969, on page 62910, the following correction is 
made:
    On page 62910, in the first column under the DATES: caption, the 
sentence is corrected to read, ``Submit either electronic or written 
comments on Agency guidances at any time.''

    Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23514 Filed 9-28-16; 8:45 am]
 BILLING CODE 4164-01-P