81 FR 72066 - Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 202 (October 19, 2016)
Federal Register Volume 81, Issue 202 (October 19, 2016)
| Page Range | 72066-72067 | |
| FR Document | 2016-25307 |
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)] [Notices] [Pages 72066-72067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25307] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice. ----------------------------------------------------------------------- Authority: 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended. The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formation and use of advisory committees. SUMMARY: The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of two Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated. DATES: Applications for individuals to be considered for appointment to the Committee must be received no later than 5 p.m. EDT on November 18, 2016 at the address listed below. ADDRESSES: All nominations should be mailed or delivered to Commander, (CDR) Gustavo Seinos, MPH, Designated [[Page 72067]] Federal Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's Health, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Avenue SW., Room 712E, Washington, DC 20201. Nomination materials, including attachments, may be submitted electronically to [email protected]. FOR FURTHER INFORMATION CONTACT: CDR Gustavo Seinos, Designated Federal Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's Health, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Ave. SW., Room 712E, Washington, DC 20201. Inquiries may also be made to [email protected]. SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002. The purpose of the CFSAC is to provide advice and recommendations to the Secretary of HHS, through the ASH, on issues related to ME/CFS. The CFSAC advises and makes recommendations on a broad range of topics including: (1) Opportunities to improve knowledge and research about the epidemiology, etiologies, biomarkers and risk factors for ME/CFS; (2) research on the diagnosis, treatment, and management of ME/CFS and potential impact of treatment options; (3) strategies to inform the public, health care professionals, and the biomedical academic and research communities about ME/CFS advances; (4) partnerships to improve the quality of life of ME/CFS patients; and (5) strategies to insure that input from ME/CFS patients and caregivers is incorporated into HHS policy and research. The CFSAC charter is available at: http://www.hhs.gov/advcomcfs/charter/index.html. Management and support services for Committee activities are provided by staff from within the OASH. The ASH provides direction and guidance for services performed to support CFSAC activities and operation. Nominations: OASH is requesting nominations to fill CFSAC positions scheduled to be vacated at the end of 2016. The Committee composition consists of seven scientists with demonstrated expertise in biomedical research applicable to ME/CFS, four individuals with demonstrated expertise in health care delivery, private health care services, insurance, and three patients/care givers of ME/CFS. The vacant positions are in the biomedical research category. Individuals selected for appointment to the Committee will serve as voting members and may be invited to serve terms of up to four years. CFSAC members are authorized to receive a stipend for conducting Committee related business, including attending Committee meetings. Committee members also are authorized to receive per diem and reimbursement for travel expenses incurred for conducting Committee related business. To qualify for consideration of appointment to the Committee, an individual must possess demonstrated experience and knowledge in the designated fields or disciplines, as well as expert knowledge of the broad issues and topics pertinent to ME/CFS. Nomination materials should be typewritten. If mailed, please submit original documents. The nomination materials should be submitted (postmarked or received) no later than 5:00 p.m. EDT on the specified date. The following information must be part of the nomination package submitted for each individual being nominated: (1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity), and a statement that the nominee is willing to serve as a member of the Committee; (2) the nominator's name, address, and daytime telephone number; (3) the home and/or work address, telephone number, and email address of the individual being nominated; and (4) a current copy of the nominee's curriculum vitae or resume, which should not exceed 10 pages. An individual may self-nominate. Federal employees should not be nominated for consideration of appointment to this Committee. Nominations that do not contain all of the above information will not be considered. Electronic submissions: Nomination materials, including attachments, may be submitted electronically to [email protected]. Regular, Express, or Overnight Mail: Written documents may be submitted to the following addressee only: CDR Gustavo Seinos, MPH, Designated Federal Officer, CFSAC, Office on Women's Health, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Ave. SW., Room 712E, Washington, DC 20201. Telephone and facsimile submissions cannot be accepted. Appointment to the Committee is made by the Secretary of HHS. The Department makes every effort to ensure that the membership of federal advisory committees is fairly balanced in terms of points of view represented. Every effort is made to ensure that a broad representation of geographic areas, females, ethnic and minority groups, and people with disabilities are given consideration for membership on federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Nominations must state that the nominee is willing to serve as a member of CFSAC and appears to have no conflict of interest that would preclude membership. Candidates who are selected for appointment to the Committee are required to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts for an ethics analysis to be conducted to identify potential conflicts of interest. Dated: October 14, 2016. Nicole Greene, Deputy Director, Office on Women's Health. [FR Doc. 2016-25307 Filed 10-18-16; 8:45 am] BILLING CODE 4150-42-P
![72066 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
any identified deficiencies and what into identifiable files to ensure the The applicant determines which
information is required to correct those device’s continued safety and records should be maintained during
deficiencies. FDA must also promptly effectiveness. These records are required product development to document and/
notify the applicant if FDA identifies of all applicants who have an approved or substantiate the device’s safety and
additional deficiencies or of any PMA. effectiveness. Records required by the
additional information required to PMAs have been required since 1976, current good manufacturing practices
complete Agency review. and there are 725 active PMAs that for medical devices regulation (21 CFR
could be subject to these requirements, part 820) may be relevant to a PMA
Recordkeeping
based on actual FDA data, and review and may be submitted as part of
§ 814.82(a)(5) and (a)(6)— approximately 30 new PMAs are an application. In individual instances,
Maintenance of Records. The approved every year. The aggregate records may be required as conditions of
recordkeeping burden under this section burden for the estimated 422 PMA approval to ensure the device’s
requires the maintenance of records, holders of approved original PMAs for continuing safety and effectiveness.
used to trace patients and the the next few years is estimated to be FDA estimates the burden of this
organization and indexing of records 7,174 hours. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity/21 CFR or FD&C Act section burden per Total hours
respondents per responses response
respondent
Research conducted outside the United States (814.15(b)) 25 1 25 2 50
PMA application (814.20) .................................................... 35 1 35 668 23,380
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) ............................................................................. 1,222 1 1,222 167 204,074
PMA supplements (814.39(a)) ............................................. 695 1 695 60 41,700
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................ 88 1 88 6 528
30-day notice (814.39(f)) ..................................................... 1,710 1 1,710 16 27,360
Postapproval requirements (814.82(a)(9)) ........................... 340 1 340 135 45,900
Periodic reports (814.84(b)) ................................................. 695 1 695 10 6,950
Agreement meeting (520(g)(7)) ........................................... 1 1 1 50 50
Expedited review request (515(d)(5) of the FD&C Act) ...... 6 1 6 10 60
Determination Meeting (513(1)(3)(D) of the FD&C Act) ...... 1 1 1 50 50
Panel meeting (515(c)(3) of the FD&C Act) ........................ 9 1 9 30 270
Day 100 meeting (515(d)(3) of the FD&C Act) ................... 19 1 19 10 190
Total .............................................................................. ........................ ........................ ........................ ........................ 350,562
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of records Total annual
Activity/21 CFR section burden per Total hours
recordkeepers per records recordkeeping
recordkeeper
Maintenance of records (814.82(a)(5) and (a)(6)) ............... 422 1 422 17 7,174
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2016. ACTION: Notice. Secretary for Health (ASH), on a broad
Leslie Kux, range of issues and topics related to
Associate Commissioner for Policy. Authority: 42 U.S.C. 217a, Section 222 of myalgic encephalomyelitis/chronic
[FR Doc. 2016–25232 Filed 10–18–16; 8:45 am] the Public Health Service Act, as amended. fatigue syndrome (ME/CFS). The
BILLING CODE 4164–01–P
The Committee is governed by the provisions appointments of two Committee
of Public Law 92–463, as amended (5 U.S.C. members are scheduled to end during
App. 2), which sets forth standards for the the 2016 calendar year. Nominations of
formation and use of advisory committees. qualified candidates are being sought to
DEPARTMENT OF HEALTH AND
HUMAN SERVICES SUMMARY: The Office of the Assistant fill the positions that are scheduled to
Secretary for Health (OASH), within the be vacated.
Solicitation for Applications From DATES: Applications for individuals to
Department of Health and Human
sradovich on DSK3GMQ082PROD with NOTICES
Individuals Interested in Being be considered for appointment to the
Services (HHS), is seeking nominations
Appointed to the Chronic Fatigue Committee must be received no later
of qualified candidates to be considered
Syndrome Advisory Committee than 5 p.m. EDT on November 18, 2016
for appointment as members of the
AGENCY: Department of Health and Chronic Fatigue Syndrome Advisory at the address listed below.
Human Services, Office of the Secretary, Committee (CFSAC). CFSAC provides ADDRESSES: All nominations should be
Office of the Assistant Secretary for advice and recommendations to the mailed or delivered to Commander,
Health. Secretary of HHS, through the Assistant (CDR) Gustavo Seinos, MPH, Designated
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![Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices 72067
Federal Officer, Chronic Fatigue invited to serve terms of up to four is made to ensure that a broad
Syndrome Advisory Committee, Office years. representation of geographic areas,
on Women’s Health, Office of the CFSAC members are authorized to females, ethnic and minority groups,
Assistant Secretary for Health, receive a stipend for conducting and people with disabilities are given
Department of Health and Human Committee related business, including consideration for membership on
Services, 200 Independence Avenue attending Committee meetings. federal advisory committees.
SW., Room 712E, Washington, DC Committee members also are authorized Appointment to this Committee shall be
20201. Nomination materials, including to receive per diem and reimbursement made without discrimination on the
attachments, may be submitted for travel expenses incurred for basis of age, race, ethnicity, gender,
electronically to cfsac@hhs.gov. conducting Committee related business. sexual orientation, disability, and
FOR FURTHER INFORMATION CONTACT: CDR To qualify for consideration of cultural, religious, or socioeconomic
Gustavo Seinos, Designated Federal appointment to the Committee, an status. Nominations must state that the
Officer, Chronic Fatigue Syndrome individual must possess demonstrated nominee is willing to serve as a member
Advisory Committee, Office on experience and knowledge in the of CFSAC and appears to have no
Women’s Health, Office of the Assistant designated fields or disciplines, as well conflict of interest that would preclude
Secretary for Health, Department of as expert knowledge of the broad issues membership. Candidates who are
Health and Human Services, 200 and topics pertinent to ME/CFS. selected for appointment to the
Independence Ave. SW., Room 712E, Nomination materials should be Committee are required to provide
typewritten. If mailed, please submit detailed information concerning such
Washington, DC 20201. Inquiries may
original documents. The nomination matters as financial holdings,
also be made to cfsac@hhs.gov.
materials should be submitted consultancies, and research grants or
SUPPLEMENTARY INFORMATION: CFSAC
(postmarked or received) no later than contracts for an ethics analysis to be
was established on September 5, 2002. 5:00 p.m. EDT on the specified date.
The purpose of the CFSAC is to provide conducted to identify potential conflicts
The following information must be part of interest.
advice and recommendations to the of the nomination package submitted for
Secretary of HHS, through the ASH, on each individual being nominated: (1) A Dated: October 14, 2016.
issues related to ME/CFS. The CFSAC letter of nomination that clearly states Nicole Greene,
advises and makes recommendations on the name and affiliation of the nominee, Deputy Director, Office on Women’s Health.
a broad range of topics including: (1) the basis for the nomination (i.e., [FR Doc. 2016–25307 Filed 10–18–16; 8:45 am]
Opportunities to improve knowledge specific attributes which qualify the BILLING CODE 4150–42–P
and research about the epidemiology, nominee for service in this capacity),
etiologies, biomarkers and risk factors and a statement that the nominee is
for ME/CFS; (2) research on the willing to serve as a member of the DEPARTMENT OF HEALTH AND
diagnosis, treatment, and management Committee; (2) the nominator’s name, HUMAN SERVICES
of ME/CFS and potential impact of address, and daytime telephone
treatment options; (3) strategies to number; (3) the home and/or work National Institutes of Health
inform the public, health care address, telephone number, and email
professionals, and the biomedical address of the individual being National Human Genome Research
academic and research communities nominated; and (4) a current copy of the Institute; Notice of Closed Meeting
about ME/CFS advances; (4) nominee’s curriculum vitae or resume, Pursuant to section 10(d) of the
partnerships to improve the quality of which should not exceed 10 pages. An Federal Advisory Committee Act, as
life of ME/CFS patients; and (5) individual may self-nominate. Federal amended (5 U.S.C. App.), notice is
strategies to insure that input from ME/ employees should not be nominated for hereby given of a meeting of the Board
CFS patients and caregivers is consideration of appointment to this of Scientific Counselors, National
incorporated into HHS policy and Committee. Nominations that do not Human Genome Research Institute.
research. The CFSAC charter is contain all of the above information will The meeting will be closed to the
available at: http://www.hhs.gov/ not be considered. public as indicated below in accordance
advcomcfs/charter/index.html. Electronic submissions: Nomination with the provisions set forth in section
Management and support services for materials, including attachments, may 552b(c)(6), Title 5 U.S.C., as amended
Committee activities are provided by be submitted electronically to cfsac@ for the review, discussion, and
staff from within the OASH. The ASH hhs.gov. evaluation of individual intramural
provides direction and guidance for Regular, Express, or Overnight Mail: programs and projects conducted by the
services performed to support CFSAC Written documents may be submitted to NATIONAL HUMAN GENOME
activities and operation. the following addressee only: CDR RESEARCH INSTITUTE, including
Nominations: OASH is requesting Gustavo Seinos, MPH, Designated consideration of personnel
nominations to fill CFSAC positions Federal Officer, CFSAC, Office on qualifications and performance, and the
scheduled to be vacated at the end of Women’s Health, Office of the Assistant competence of individual investigators,
2016. The Committee composition Secretary for Health, Department of the disclosure of which would
consists of seven scientists with Health and Human Services, 200 constitute a clearly unwarranted
demonstrated expertise in biomedical Independence Ave. SW., Room 712E, invasion of personal privacy.
research applicable to ME/CFS, four Washington, DC 20201.
individuals with demonstrated expertise Name of Committee: Board of Scientific
sradovich on DSK3GMQ082PROD with NOTICES
Telephone and facsimile submissions
in health care delivery, private health cannot be accepted. Counselors, National Human Genome
care services, insurance, and three Appointment to the Committee is Research Institute.
Date: November 1–2, 2016.
patients/care givers of ME/CFS. The made by the Secretary of HHS. The Time: November 1, 2016, 6:00 p.m. to 9:30
vacant positions are in the biomedical Department makes every effort to ensure p.m.
research category. Individuals selected that the membership of federal advisory Agenda: To review and evaluate personal
for appointment to the Committee will committees is fairly balanced in terms of qualifications and performance, and
serve as voting members and may be points of view represented. Every effort competence of individual investigators.
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Document Created: 2016-10-19 02:11:50
Document Modified: 2016-10-19 02:11:50
| 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 | Applications for individuals to be considered for appointment to the Committee must be received no later than 5 p.m. EDT on November 18, | |
| Contact | CDR Gustavo Seinos, Designated Federal Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's Health, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Ave. SW., Room 712E, Washington, DC 20201. Inquiries may also be made to [email protected] | |
| FR Citation | 81 FR 72066 |
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