Science Board to the Food and Drug Administration; Notice of Meeting, 40070-40071 [2015-16957]

Download as PDF 40070 Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response 52 1 .25 LIHEAP Quarterly Allocation Estimates, Form ACF–535 ................................ Estimated Total Annual Burden Hours: 13. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–17030 Filed 7–10–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. asabaliauskas on DSK5VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice to the Commissioner of Food and Drugs VerDate Sep<11>2014 19:27 Jul 10, 2015 Jkt 235001 and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency’s research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. Date and Time: The meeting will be held on July 29, 2015, from 8:30 a.m. to 4 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503 B and C), Silver Spring, MD 20993–0002. For those unable to attend in person, the meeting will also be Webcast. The link for the Webcast is available at: https:// collaboration.fda.gov/ scienceboard2015/. 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. Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, Bldg. 1, Rm. 3309, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–4769, rakesh.raghuwanshi@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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Total burden hours 13 modifications before coming to the meeting. Agenda: The Science Board will be provided with a report from the Commissioner’s Fellowship Program Evaluation subcommittee and will be provided with a progress report from the Science Looking Forward subcommittee. The Board will hear an overview of two scientific activities from the Center for Veterinary Medicine and will be asked to provide input on strategies to implement targeted directives contained in the National Strategy for Combating AntibioticResistant Bacteria, designed to guide action by public health, health care, and veterinary partners in a common effort to address urgent and serious drugresistant threats that affect people in the United States and around the world. A recipient of one of the Fiscal Year 2014 Scientific Achievement Awards (selected by the Board) will provide an overview of the activities for which the award was given. A status update on the 21st Century Cures Act will be presented, and the Deputy Commissioner for Medical Products and Tobacco will discuss his vision for the Office of Medical Products and Tobacco. 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: 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 22, 2015. Oral presentations from the public will be scheduled between approximately 2:45 and 3:45 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 E:\FR\FM\13JYN1.SGM 13JYN1 Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices 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 14, 2015. 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 15, 2015. 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Mr. Rakesh Raghuwanshi 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: July 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–16957 Filed 7–10–15; 8:45 am] asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0147] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 12, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0673. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products OMB Control Number 0910– 0673—Extension On June 22, 2009, the President signed the Family Smoking Prevention VerDate Sep<11>2014 19:27 Jul 10, 2015 Jkt 235001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 40071 and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111–31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C. 387e(j)) authorizes FDA to establish the manner and form for the submission of information related to substantial equivalence (SE). In guidance documents issued under the Good Guidances Practices regulation (21 CFR 10.115), FDA provides recommendations intended to assist persons submitting reports under section 905(j) of the FD&C Act and explains, among other things, FDA’s interpretation of the statutory sections related to substantial equivalence. In the Federal Register of March 5, 2015 (80 FR 11989), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment. The commenter expressed a concern that small manufacturers have the burden of conducting testing without a definitive guide on what will constitute substantial equivalence. FDA has carefully considered the burden associated with the submission of an SE report. The information needed to demonstrate substantial equivalence is dependent on the new product and the predicate product that the manufacturer identifies. Nevertheless, to assist manufacturers in preparing SE reports, FDA has issued guidance documents and participated in outreach such as webinars to provide manufacturers with information. Moreover, manufacturers seeking to demonstrate substantial equivalence may also contact FDA to seek the Agency’s input on the specific types of information that the Agency believes will be necessary to support the manufacturer’s section 905(j) report. The commenter also supported FDA’s development of more streamlined SE Reports but challenged ‘‘new requirements on label changes,’’ and requested that FDA promulgate a rule on categorical exclusions (environmental assessments). Although these comments are outside of the scope of this PRA collection, FDA intends to consider them as part of the Agency’s other regulatory efforts as appropriate. FDA estimates the burden of this collection of information as follows: E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40070-40071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Science Board to the Food and Drug Administration; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Science Board to the Food and Drug 
Administration (Science Board).
    General Function of the Committee: The Science Board provides 
advice to the Commissioner of Food and Drugs and other appropriate 
officials on specific, complex scientific and technical issues 
important to FDA and its mission, including emerging issues within the 
scientific community. Additionally, the Science Board provides advice 
to the Agency on keeping pace with technical and scientific 
developments including in regulatory science, input into the Agency's 
research agenda, and on upgrading its scientific and research 
facilities and training opportunities. It will also provide, where 
requested, expert review of Agency sponsored intramural and extramural 
scientific research programs.
    Date and Time: The meeting will be held on July 29, 2015, from 8:30 
a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503 B and C), Silver Spring, MD 
20993-0002. For those unable to attend in person, the meeting will also 
be Webcast. The link for the Webcast is available at: https://collaboration.fda.gov/scienceboard2015/. 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.
    Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist, 
Food and Drug Administration, Bldg. 1, Rm. 3309, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4769, 
rakesh.raghuwanshi@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.
    Agenda: The Science Board will be provided with a report from the 
Commissioner's Fellowship Program Evaluation subcommittee and will be 
provided with a progress report from the Science Looking Forward 
subcommittee. The Board will hear an overview of two scientific 
activities from the Center for Veterinary Medicine and will be asked to 
provide input on strategies to implement targeted directives contained 
in the National Strategy for Combating Antibiotic-Resistant Bacteria, 
designed to guide action by public health, health care, and veterinary 
partners in a common effort to address urgent and serious drug-
resistant threats that affect people in the United States and around 
the world. A recipient of one of the Fiscal Year 2014 Scientific 
Achievement Awards (selected by the Board) will provide an overview of 
the activities for which the award was given. A status update on the 
21st Century Cures Act will be presented, and the Deputy Commissioner 
for Medical Products and Tobacco will discuss his vision for the Office 
of Medical Products and Tobacco.
    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: 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 
22, 2015. Oral presentations from the public will be scheduled between 
approximately 2:45 and 3:45 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

[[Page 40071]]

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 14, 2015. 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 15, 2015.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Mr. Rakesh 
Raghuwanshi 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: July 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16957 Filed 7-10-15; 8:45 am]
 BILLING CODE 4164-01-P

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