81 FR 76362 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 212 (November 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76362-76363 | |
| FR Document | 2016-26491 |
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)] [Notices] [Pages 76362-76363] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26491] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Science Board to the Food and Drug Administration 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 Science Board to the Food and Drug Administration. 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 [[Page 76363]] facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public. DATES: The meeting will be held on November 15, 2016, from 8:30 a.m. until 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section C), Silver Spring, MD 20993. For those unable to attend in person, the meeting will also be Web cast. The link for the Web cast is available at https://collaboration.fda.gov/sbm1116/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301-796-4769, [email protected], 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 http://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: The Science Board will hear about: (1) The Center for Biologics Evaluation and Research's strategic goals for regulatory science; (2) a progress update on FDA's Opioid Action Plan and the Bovine Heparin Initiative; (3) a response from the Office of Scientific Professional Development to the Science Board's report on the Commissioner's Fellowship Program; (4) a report from the Scientific Engagements Subcommittee; (5) and a report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee. 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 http://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 November 8, 2016. Oral presentations from the public will be scheduled between approximately 4 p.m. and 5 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 November 2, 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 November 4, 2016. 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 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 http://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: October 28, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016-26491 Filed 11-1-16; 8:45 am] BILLING CODE 4164-01-P
![76362 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
Section 1270.33(a) requires records to be information provided by industry, there 1270. Therefore, their information
maintained concurrently with the are estimated totals of 2,141,960 collection burden is for the general
performance of each significant step conventional tissue products and review and update of written
required in the performance of 130,987 eye tissue products distributed procedures estimated to take an annual
infectious disease screening and testing per year with an average of 25 percent average of 24 hours, and for the
of human tissue donors. Section of the tissue discarded due to recording and justifying of any
1270.33(f) requires records to be unsuitability for transplant. In addition, deviations from the written procedures
retained regarding the determination of there are an estimated 29,799 deceased under § 1270.31(a) and (b), estimated to
the suitability of the donors and of the donors of conventional tissue and take an annual average of 1 hour. The
records required under § 1270.21. 70,027 deceased donors of eye tissue information collection burden for
Section 1270.33(h) requires all records each year. maintaining records concurrently with
to be retained for at least 10 years Accredited members of the American the performance of each significant
beyond the date of transplantation if Association of Tissue Banks (AATB) screening and testing step and for
known, distribution, disposition, or and Eye Bank Association of America retaining records for 10 years under
expiration of the tissue, whichever is (EBAA) adhere to standards of those § 1270.33(a), (f), and (h) include
the latest. Section 1270.35(a) through (d) organizations that are comparable to the documenting the results and
requires specific records to be recordkeeping requirements in part interpretation of all required infectious
maintained to document the following: 1270. Based on information provided by disease tests and results and the identity
(1) The results and interpretation of all CBER’s database system, 90 percent of and relevant medical records of the
required infectious disease tests; (2) the conventional tissue banks are donor required under § 1270.35(a) and
information on the identity and relevant members of AATB (262 × 90% = 236), (b). Therefore, the burden under these
medical records of the donor; (3) the and 95 percent of eye tissue banks are provisions is calculated together in table
receipt and/or distribution of human members of EBAA (121 × 95% = 115). 1. The recordkeeping estimates for the
tissue, and (4) the destruction or other Therefore, recordkeeping by these 351 number of total annual records and
disposition of human tissue. establishments (236 + 115 = 351) is hours per record are based on
Respondents to this collection of excluded from the burden estimates as information provided by industry and
information are manufacturers of human usual and customary business activities FDA experience.
tissue intended for transplantation. (5 CFR 1320.3(b)(2)). The recordkeeping In the Federal Register of June 6, 2016
Based on information from the Center burden, thus, is estimated for the (81 FR 36310), we published a 60-day
for Biologics Evaluation and Research’s remaining 32 establishments, which is notice requesting public comment on
(CBER’s) database system, FDA 8.36 percent of all establishments (383 the proposed extension of this
estimates that there are approximately ¥ 351 = 32, or 32/383 = 8.36%). collection of information. No comments
383 tissue establishments, of which 262 FDA assumes that all current tissue were received.
are conventional tissue banks and 121 establishments have developed written FDA estimates the burden of this
are eye tissue banks. Based on procedures in compliance with part information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
ecordkeeper recordkeeping
1270.31(a), (b), (c), and (d) 2 ..................................... 32 1 32 24 768
1270.31(a) and 1270.31(b) 3 ...................................... 32 2 64 1 64
1270.33(a), (f), and (h), and 1270.35(a) and (b) ....... 32 6,198.84 198,363 1 198,363
1270.35(c) .................................................................. 32 11,876.12 380,036 1 380,036
1270.35(d) .................................................................. 32 1,484.50 47,504 1 47,504
Total .................................................................... .......................... .......................... .......................... .......................... 626,735
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Review and update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.
Dated: October 27, 2016. DEPARTMENT OF HEALTH AND forthcoming public advisory committee
Leslie Kux, HUMAN SERVICES meeting of the Science Board to the
Associate Commissioner for Policy. Food and Drug Administration. The
Food and Drug Administration Science Board provides advice to the
[FR Doc. 2016–26398 Filed 11–1–16; 8:45 am]
Commissioner of Food and Drugs and
BILLING CODE 4164–01–P [Docket No. FDA–2016–N–0001] other appropriate officials on specific,
complex scientific and technical issues
Science Board to the Food and Drug
important to FDA and its mission,
Administration Advisory Committee;
including emerging issues within the
sradovich on DSK3GMQ082PROD with NOTICES
Notice of Meeting
scientific community. Additionally, the
AGENCY: Food and Drug Administration, Science Board provides advice to the
HHS. Agency on keeping pace with technical
ACTION: Notice. and scientific developments including
in regulatory science, input into the
SUMMARY: The Food and Drug Agency’s research agenda and on
Administration (FDA) announces a upgrading its scientific and research
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![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76363
facilities and training opportunities. It FDA intends to make background Dated: October 28, 2016.
will also provide, where requested, material available to the public no later Janice M. Soreth,
expert review of Agency sponsored than 2 business days before the meeting. Acting Associate Commissioner, Special
intramural and extramural scientific If FDA is unable to post the background Medical Programs.
research programs. The meeting will be material on its Web site prior to the [FR Doc. 2016–26491 Filed 11–1–16; 8:45 am]
open to the public. meeting, the background material will BILLING CODE 4164–01–P
DATES: The meeting will be held on be made publicly available at the
November 15, 2016, from 8:30 a.m. until location of the advisory committee
5 p.m. meeting, and the background material DEPARTMENT OF HEALTH AND
will be posted on FDA’s Web site after HUMAN SERVICES
ADDRESSES: FDA White Oak Campus,
the meeting. Background material is
10903 New Hampshire Ave., Building Health Resources and Services
available at http://www.fda.gov/
31 Conference Center, the Great Room Administration
AdvisoryCommittees/Calendar/
(Rm. 1503, Section C), Silver Spring,
default.htm. Scroll down to the
MD 20993. For those unable to attend in Agency Information Collection
appropriate advisory committee meeting
person, the meeting will also be Web link. Activities: Submission to OMB for
cast. The link for the Web cast is Procedure: Interested persons may Review and Approval; Public Comment
available at https:// present data, information, or views, Request
collaboration.fda.gov/sbm1116/. orally or in writing, on issues pending
Answers to commonly asked questions AGENCY: Health Resources and Services
before the committee. Written Administration (HRSA), Department of
including information regarding special submissions may be made to the contact
accommodations due to a disability, Health and Human Services.
person on or before November 8, 2016. ACTION: Notice.
visitor parking, and transportation may Oral presentations from the public will
be accessed at: http://www.fda.gov/ be scheduled between approximately 4 SUMMARY: In compliance with Section
AdvisoryCommittees/ p.m. and 5 p.m. Those individuals 3507(a)(1)(D) of the Paperwork
AboutAdvisoryCommittees/ interested in making formal oral Reduction Act of 1995, HRSA has
ucm408555.htm. presentations should notify the contact submitted an Information Collection
FOR FURTHER INFORMATION CONTACT: person and submit a brief statement of Request (ICR) to the Office of
Rakesh Raghuwanshi, Office of the the general nature of the evidence or Management and Budget (OMB) for
Chief Scientist, Office of the arguments they wish to present, the review and approval. Comments
Commissioner, Food and Drug names and addresses of proposed submitted during the first public review
Administration, 10903 New Hampshire participants, and an indication of the of this ICR will be provided to OMB.
Ave., Bldg. 1, Rm. 3309, Silver Spring, approximate time requested to make OMB will accept further comments from
MD 20993, 301–796–4769, their presentation on or before the public during the review and
rakesh.raghuwanshi@fda.hhs.gov, or November 2, 2016. Time allotted for approval period.
FDA Advisory Committee Information each presentation may be limited. If the DATES: Comments on this ICR should be
Line, 1–800–741–8138 (301–443–0572 number of registrants requesting to received no later than December 2,
in the Washington, DC area). A notice in speak is greater than can be reasonably 2016.
the Federal Register about last minute accommodated during the scheduled
open public hearing session, FDA may ADDRESSES: Submit your comments,
modifications that impact a previously including the Information Collection
announced advisory committee meeting conduct a lottery to determine the
speakers for the scheduled open public Request Title, to the desk officer for
cannot always be published quickly HRSA, either by email to OIRA_
enough to provide timely notice. hearing session. The contact person will
notify interested persons regarding their submission@omb.eop.gov or by fax to
Therefore, you should always check the 202–395–5806.
Agency’s Web site at http:// request to speak by November 4, 2016.
Persons attending FDA’s advisory FOR FURTHER INFORMATION CONTACT: To
www.fda.gov/AdvisoryCommittees/
committee meetings are advised that the request a copy of the clearance requests
default.htm and scroll down to the
Agency is not responsible for providing submitted to OMB for review, email the
appropriate advisory committee meeting
access to electrical outlets. HRSA Information Collection Clearance
link, or call the advisory committee
FDA welcomes the attendance of the Officer at paperwork@hrsa.gov or call
information line to learn about possible
public at its advisory committee (301) 443–1984.
modifications before coming to the
meeting. meetings and will make every effort to SUPPLEMENTARY INFORMATION:
accommodate persons with disabilities. Information Collection Request Title:
SUPPLEMENTARY INFORMATION: If you require accommodations due to a Telehealth Outcome Measures OMB No.
Agenda: The Science Board will hear disability, please contact Rakesh 0915–0311—Revision.
about: (1) The Center for Biologics Raghuwanshi at least 7 days in advance Abstract: To help carry out its
Evaluation and Research’s strategic of the meeting. mission, the Office for the Advancement
goals for regulatory science; (2) a FDA is committed to the orderly of Telehealth (OAT) created a set of
progress update on FDA’s Opioid conduct of its advisory committee performance measures that grantees use
Action Plan and the Bovine Heparin meetings. Please visit our Web site at to evaluate the effectiveness of their
Initiative; (3) a response from the Office http://www.fda.gov/ services programs and monitor their
of Scientific Professional Development
sradovich on DSK3GMQ082PROD with NOTICES
AdvisoryCommittees/ progress through the use of performance
to the Science Board’s report on the AboutAdvisoryCommittees/ reporting data.
Commissioner’s Fellowship Program; (4) ucm111462.htm for procedures on Need and Proposed Use of the
a report from the Scientific Engagements public conduct during advisory Information: As required by the
Subcommittee; (5) and a report from the committee meetings. Government Performance and Results
Food Emergency Response Network Notice of this meeting is given under Act of 1993, all federal agencies must
Cooperative Agreement Program the Federal Advisory Committee Act (5 develop strategic plans describing their
Evaluation Subcommittee. U.S.C. app. 2). overall goal and objectives. HRSA’s
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Document Created: 2016-11-02 01:41:06
Document Modified: 2016-11-02 01:41:06
| 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. | |
| Dates | The meeting will be held on November 15, 2016, from 8:30 a.m. until 5 p.m. | |
| Contact | Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301-796-4769, [email protected], 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 http://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. | |
| FR Citation | 81 FR 76362 |
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