Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 36923-36924 [2016-13457]

Download as PDF 36923 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices Participants will be underground mining personnel drawn from a variety of operating underground coal mines. Descriptive and inferential statistics on data obtained from the survey will be used quantify miner self-escape competence and to identify any statistically significant relationships among aggregated miner characteristics and perceived competence. Finally, the data will serve as a gross baseline measure of miner self-escape competence to be directly compared to future data collection utilizing the identical data collection instrument. The total estimated annualized burden hours are 67. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Mine Worker .................................................... Survey ............................................................ 400 1 10/60 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016–13571 Filed 6–7–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services II. Summary of Errors [CMS–5520–CN] Announcement of Requirements and Registration for ‘‘A Bill You Can Understand’’ Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health; Correction Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice; correction. AGENCY: This document corrects technical errors that appeared in the notice published in the May 10, 2016 Federal Register entitled ‘‘Announcement of Requirements and Registration for ‘‘A Bill You Can Understand’’ Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health.’’ DATES: Effective June 3, 2016. FOR FURTHER INFORMATION CONTACT: Ben Shannon, Communications Advisor, Office of the Assistant Secretary for Public Affairs, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20210, phone (202) 205–2819, email ben.shanon@hhs.gov. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: I. Background In FR Doc. 2016–10980 (81 FR 28873 through 28875), the notice entitled ‘‘Announcement of Requirements and VerDate Sep<11>2014 17:30 Jun 07, 2016 Jkt 238001 Registration for ‘‘A Bill You Can Understand’’ Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health,’’ there were a number of technical errors that are identified and corrected in section III., the Correction of Errors. The provisions in this correction document are effective as if they had been included in the document published May 10, 2016. Accordingly, the corrections are effective June 3, 2016. On page 28874, under the heading ‘‘A. Subject of the Challenge Competition’’, and page 29975, under the heading ‘‘F. Basis Upon Which the Winners Will Be Selected’’, we inadvertently omitted clarifying language. III. Correction of Errors In FR Doc. 2016–10980 of May 10, 2016 (81 FR 28873), make the following corrections: 1. On page 28874, first column; fourth paragraph, under the heading ‘‘A. Subject of the Challenge Competition’’, lines 8 through 16, the sentences ‘‘Participants will be asked to submit entries that improve both the design of the medical bill and patient experience of the medical billing process. Submissions will include the (1) design concept for the redesigned medical bill, (2) journey map or wireframe for the redesigned patient experience,’’ are corrected to read ’’Participants will be asked to submit entries that improve both the design of the medical bill and other materials and tools the patient sees and interacts with as well as the patient experience of the medical billing process. Submissions will include the: (1) Design concept for the redesigned medical bill and other materials and tools the patient sees and interacts with, (2) journey map of the redesigned patient experience,’’ 2. On page 28875, first column; in the paragraph following the heading; ‘‘F. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Basis Upon Which the Winners Will Be Selected’’, the bullet point statements: ‘‘• Contains all Necessary Data and Information. • Usefulness and Understandability of Patient Facing Materials (Bill or Otherwise). • Adherence to Plain Language Guidelines. • Transparency of Data (Including How the Data is Translated and Explained).’’ are corrected to read: ‘‘• Most Appropriate Use of Data and Information. • Addresses Top Concerns Associated with the Current Medical Billing Experience. • Usefulness and Understandability of Patient Facing Materials (Bill or Otherwise). • Use of Human-Centered Design Process in Creation of Concept. • Use of Plain Language.’’ Dated: June 2, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016–13548 Filed 6–3–16; 4:15 pm] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. SUMMARY: E:\FR\FM\08JNN1.SGM 08JNN1 mstockstill on DSK3G9T082PROD with NOTICES 36924 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on July 26, 2016, from 1 p.m. to 3:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Janie Kim or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 301–796–9016 or 240–402–8158, email: Janie.Kim@ fda.hhs.gov or Denise.Royster@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https://www.fda. gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Biological Chemistry and Laboratory of Molecular Oncology, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. VerDate Sep<11>2014 17:30 Jun 07, 2016 Jkt 238001 Procedure: On July 26, 2016, from 1 p.m. to 3:30 p.m., the meeting is open to the public. 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 July 12, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 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 July 1, 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 July 5, 2016. Closed Committee Deliberations: On July 26, 2016, from 2:30 p.m. to 3:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. 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 Janie Kim 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 https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ 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). PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Dated: June 2, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–13457 Filed 6–7–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0134] Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) 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 solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements. DATES: Submit either electronic or written comments on the collection of information by August 8, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36923-36924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Cellular, Tissue and Gene Therapies Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Cellular, Tissue and Gene 
Therapies Advisory Committee. The general function of the committee is 
to provide advice and recommendations to the Agency on FDA's regulatory 
issues.

[[Page 36924]]

At least one portion of the meeting will be closed to the public.

DATES: The meeting will be held on July 26, 2016, from 1 p.m. to 3:30 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Janie Kim or Denise Royster, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-
796-9016 or 240-402-8158, email: Janie.Kim@fda.hhs.gov or 
Denise.Royster@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last-minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On July 26, 2016, the committee will meet by 
teleconference. In open session, the committee will hear updates of 
research programs in the Laboratory of Biological Chemistry and 
Laboratory of Molecular Oncology, Division of Biotechnology Review and 
Research 1 and 4, Office of Biotechnology Products, Center for Drug 
Evaluation and Research, FDA.
    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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On July 26, 2016, from 1 p.m. to 3:30 p.m., the meeting 
is open to the public. 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 July 12, 2016. Oral presentations from the public will be 
scheduled between approximately 1:30 p.m. and 2:30 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 July 
1, 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 July 5, 2016.
    Closed Committee Deliberations: On July 26, 2016, from 2:30 p.m. to 
3:30 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
intramural research programs and make recommendations regarding 
personnel staffing decisions.
    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 Janie Kim 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/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 2, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-13457 Filed 6-7-16; 8:45 am]
 BILLING CODE 4164-01-P

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