81 FR 85231 - Request for Nominations on the Blood Products Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 227 (November 25, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 227 (November 25, 2016)
| Page Range | 85231-85232 | |
| FR Document | 2016-28306 |
[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)] [Notices] [Pages 85231-85232] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28306] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Request for Nominations on the Blood Products Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by December 23, 2016. See sections I and II of this document for further details. Concurrently, nomination materials for prospective candidates should be sent to FDA by December 23, 2016. ADDRESSES: All statements of interest from industry organizations that wish to participate in the selection process of nonvoting industry representative nomination should be sent to Bryan Emery (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA's Web site http://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific Advisors and Consultants, CBER, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240-402-8054, Fax: 301-595-1307, email: [email protected]. SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting industry representative(s) to the following advisory committee: I. CBER Blood Products Advisory Committee The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood; products derived from blood and serum or biotechnology intended for use in the diagnosis, prevention, or treatment of human diseases; and, as required, any other product for which FDA has regulatory responsibility. The Committee then advises the Commissioner of Food and Drugs of its findings regarding screening, testing, and labeling of products on clinical and laboratory studies involving such products on the affirmation or revocation of biological products licenses, as well as on the quality and relevance of FDA's research program that provides the scientific support for regulating these agents. The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) Medical Device Amendments of 1976. As such, the Committee: (1) Recommends classification of devices subject to its review into regulatory categories, (2) recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category, (3) advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate, (4) recommends exemption of certain devices from the application of portions of the FD&C Act, (5) advises on the necessity to ban a device, and (6) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). [[Page 85232]] FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: November 18, 2016. Janice M. Soreth, Associate Commissioner, Special Medical Programs. [FR Doc. 2016-28306 Filed 11-23-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Notices 85231
petition (Docket No. FDA–2016–P–1873, FDA by December 23, 2016. See sections Recommends classification of devices
available at https:// I and II of this document for further subject to its review into regulatory
www.regulations.gov/). details. Concurrently, nomination categories, (2) recommends the
This revised draft guidance is being materials for prospective candidates assignment of a priority for the
issued consistent with FDA’s good should be sent to FDA by December 23, application of regulatory requirements
guidance practices regulation (21 CFR 2016. for devices classified in the standards or
10.115). The draft guidance, when ADDRESSES: All statements of interest premarket approval category, (3) advises
finalized, will represent the current from industry organizations that wish to on formulation of product development
thinking of FDA on the design of BE participate in the selection process of protocols and reviews premarket
studies to support ANDAs for nonvoting industry representative approval applications for those devices
cyclobenzaprine hydrochloride nomination should be sent to Bryan to recommend changes in classification
extended release capsules. It does not Emery (see FOR FURTHER INFORMATION as appropriate, (4) recommends
establish any rights for any person and CONTACT). All nominations for exemption of certain devices from the
is not binding on FDA or the public. nonvoting industry representatives may application of portions of the FD&C Act,
You can use an alternative approach if be submitted electronically by accessing (5) advises on the necessity to ban a
it satisfies the requirements of the the FDA Advisory Committee device, and (6) responds to requests
applicable statutes and regulations. Membership Nomination Portal: https:// from the Agency to review and make
www.accessdata.fda.gov/scripts/ recommendations on specific issues or
II. Electronic Access
FACTRSPortal/FACTRS/index.cfm or by problems concerning the safety and
Persons with access to the Internet mail to Advisory Committee Oversight effectiveness of devices.
may obtain the revised draft guidance at and Management Staff, Food and Drug
either http://www.fda.gov/Drugs/ II. Selection Procedure
Administration, 10903 New Hampshire
GuidanceComplianceRegulatory Ave., Bldg. 32, Rm. 5103, Silver Spring, Any industry organization interested
Information/Guidances/default.htm or MD 20993–0002. Information about in participating in the selection of an
https://www.regulations.gov/. becoming a member of an FDA advisory appropriate nonvoting member to
Dated: November 18, 2016. committee can also be obtained by represent industry interests should send
Leslie Kux, visiting FDA’s Web site http:// a letter stating that interest to the FDA
Associate Commissioner for Policy.
www.fda.gov/AdvisoryCommittees/ contact (see FOR FURTHER INFORMATION
default.htm. CONTACT) within 30 days of publication
[FR Doc. 2016–28334 Filed 11–23–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT: of this document (see DATES). Within the
BILLING CODE 4164–01–P
Bryan Emery, Division of Scientific subsequent 30 days, FDA will send a
Advisors and Consultants, CBER, 10903 letter to each organization that has
DEPARTMENT OF HEALTH AND New Hampshire Ave., Bldg. 71, Rm. expressed an interest, attaching a
HUMAN SERVICES 6128, Silver Spring, MD 20993–0002, complete list of all such organizations
240–402–8054, Fax: 301–595–1307, and a list of all nominees along with
Food and Drug Administration email: bryan.emery@fda.hhs.gov. their current resumes. The letter will
SUPPLEMENTARY INFORMATION: The also state that it is the responsibility of
[Docket No. FDA–2016–N–0001]
Agency intends to add a nonvoting the interested organizations to confer
Request for Nominations on the Blood industry representative(s) to the with one another and to select a
Products Advisory Committee following advisory committee: candidate, within 60 days after the
receipt of the FDA letter, to serve as the
AGENCY: Food and Drug Administration, I. CBER Blood Products Advisory nonvoting member to represent industry
HHS. Committee interests for the committee. The
ACTION: Notice. The Committee reviews and evaluates interested organizations are not bound
available data concerning the safety, by the list of nominees in selecting a
SUMMARY: The Food and Drug effectiveness, and appropriate use of candidate. However, if no individual is
Administration (FDA) is requesting that blood; products derived from blood and selected within 60 days, the
any industry organizations interested in serum or biotechnology intended for use Commissioner will select the nonvoting
participating in the selection of a in the diagnosis, prevention, or member to represent industry interests.
nonvoting industry representative to treatment of human diseases; and, as
serve on the Blood Products Advisory III. Application Procedure
required, any other product for which
Committee for the Center for Biologics FDA has regulatory responsibility. The Individuals may self-nominate and/or
Evaluation and Research (CBER) notify Committee then advises the an organization may nominate one or
FDA in writing. FDA is also requesting Commissioner of Food and Drugs of its more individuals to serve as a nonvoting
nominations for a nonvoting industry findings regarding screening, testing, industry representative. Contact
representative(s) to serve on the Blood and labeling of products on clinical and information, a current curriculum vitae,
Products Advisory Committee. A laboratory studies involving such and the name of the committee of
nominee may either be self-nominated products on the affirmation or interest should be sent to the FDA
or nominated by an organization to revocation of biological products Advisory Committee Membership
serve as a nonvoting industry licenses, as well as on the quality and Nomination Portal (see ADDRESSES)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
representative. Nominations will be relevance of FDA’s research program within 30 days of publication of this
accepted for current vacancies effective that provides the scientific support for document (see DATES). FDA will forward
with this notice. regulating these agents. The Committee all nominations to the organizations
DATES: Any industry organization will function at times as a medical expressing interest in participating in
interested in participating in the device panel under the Federal Food, the selection process for the committee.
selection of an appropriate nonvoting Drug, and Cosmetic Act (the FD&C Act) (Persons who nominate themselves as
member to represent industry interests Medical Device Amendments of 1976. nonvoting industry representatives will
must send a letter stating that interest to As such, the Committee: (1) not participate in the selection process).
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![85232 Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Notices
FDA seeks to include the views of Dated: November 18, 2016. Contact Person: Robert Finkelstein, Ph.D.,
women and men, members of all racial Michelle Trout, Director, Division of Extramural Research,
and ethnic groups, and individuals with National Institute of Neurological Disorders
Program Analyst, Office of Federal Advisory
and Stroke, NIH, 6001 Executive Blvd., Suite
and without disabilities on its advisory Committee Policy.
3309, MSC 9531, Bethesda, MD 20892, (301)
committees and, therefore, encourages [FR Doc. 2016–28301 Filed 11–23–16; 8:45 am] 496–9248.
nominations of appropriately qualified BILLING CODE 4140–01–P Any interested person may file written
candidates from these groups comments with the committee by forwarding
This notice is issued under the the statement to the Contact Person listed on
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U.S.C. app. 2) and 21 CFR part 14, HUMAN SERVICES name, address, telephone number and when
relating to advisory committees. applicable, the business or professional
National Institutes of Health affiliation of the interested person.
Dated: November 18, 2016.
In the interest of security, NIH has
Janice M. Soreth, National Institute of Neurological instituted stringent procedures for entrance
Associate Commissioner, Special Medical Disorders and Stroke; Notice of onto the NIH campus. All visitor vehicles,
Programs. Meeting including taxicabs, hotel, and airport shuttles
[FR Doc. 2016–28306 Filed 11–23–16; 8:45 am] will be inspected before being allowed on
BILLING CODE 4164–01–P
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Federal Advisory Committee Act, as form of identification (for example, a
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as amended. The grant applications and as amended. The grant applications and [FR Doc. 2016–28303 Filed 11–23–16; 8:45 am]
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Document Created: 2016-11-23 23:17:59
Document Modified: 2016-11-23 23:17:59
| 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 | Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by December 23, 2016. See sections I and II of this document for further details. Concurrently, nomination materials for prospective candidates should be sent to FDA by December 23, 2016. | |
| Contact | Bryan Emery, Division of Scientific Advisors and Consultants, CBER, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240-402-8054, Fax: 301-595-1307, email: [email protected] | |
| FR Citation | 81 FR 85231 |
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