82 FR 35974 - Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 147 (August 2, 2017)
Federal Register Volume 82, Issue 147 (August 2, 2017)
| Page Range | 35974-35975 | |
| FR Document | 2017-16156 |
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)] [Notices] [Pages 35974-35975] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16156] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections AGENCY: Office of the Assistant Secretary for Health, Office for Human Research Protections, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is [[Page 35975]] seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS (Secretary), through the Assistant Secretary for Health, on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will be vacated during the 2018 calendar year. DATES: Nominations for membership on the Committee must be received no later than September 18, 2017. ADDRESSES: Nominations should be mailed or delivered to Dr. Jerry Menikoff, Director, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Nominations will not be accepted by email or by facsimile. FOR FURTHER INFORMATION CONTACT: Julia Gorey, Executive Director, SACHRP, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, telephone: 240-453-8141. A copy of the Committee charter and list of the current members can be obtained by contacting Ms. Gorey, accessing the SACHRP Web site at www.hhs.gov/ohrp/sachrp, or requesting via email at [email protected]. SUPPLEMENTARY INFORMATION: The Committee provides advice on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. Specifically, the Committee provides advice relating to the responsible conduct of research involving human subjects with particular emphasis on special populations such as neonates and children, prisoners, the decisionally impaired, pregnant women, embryos and fetuses, individuals and populations in international studies, investigator conflicts of interest and populations in which there are individually identifiable samples, data or information. In addition, the Committee is responsible for reviewing selected ongoing work and planned activities of the OHRP and other offices/ agencies within HHS responsible for human subjects protection. These evaluations may include, but are not limited to, a review of assurance systems, the application of minimal research risk standards, the granting of waivers, education programs sponsored by OHRP, and the ongoing monitoring and oversight of institutional review boards and the institutions that sponsor research. Nominations: The OHRP is requesting nominations to fill four positions for voting members of SACHRP. One position will become vacant in January 2018, with three others becoming vacant in October 2018. Nominations of potential candidates for consideration are being sought from a wide array of fields, including, but not limited to: public health and medicine, behavioral and social sciences, health administration, and biomedical ethics. To qualify for consideration of appointment to the Committee, an individual must possess demonstrated experience and expertise in any of the several disciplines and fields pertinent to human subjects protection and/or clinical research. The individuals selected for appointment to the Committee can be invited to serve a term of up to four years. Committee members receive a stipend and reimbursement for per diem and any travel expenses incurred for attending Committee meetings and/or conducting other business in the interest of the Committee. Interested applicants may self-nominate. Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration: (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, daytime telephone number, and the home and/or work address, telephone number, and email address of the individual being nominated; and (3) a current copy of the nominee's curriculum vitae. Federal employees should not be nominated for consideration of appointment to this Committee. The Department makes every effort to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made to ensure that individuals from a broad representation of geographic areas, women and men, ethnic and minority groups, and the disabled are given consideration for membership on HHS 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. Individuals who are selected to be considered for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. Disclosure of this information is necessary in order to determine if the selected candidate is involved in any activity that may pose a potential conflict with the official duties to be performed as a member of SACHRP. 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. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: July 26, 2017. Julia Gorey, Executive Director, Secretary's Advisory Committee on Human Research Protections, Office for Human Research Protections [FR Doc. 2017-16156 Filed 8-1-17; 8:45 am] BILLING CODE 4150-36-P
![35974 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
antibacterial drugs. This guidance are subject to review by the Office of 103 of the Pandemic and All-Hazards
outlines approaches for streamlined Management and Budget (OMB) under Preparedness Reauthorization Act of
development programs that are the Paperwork Reduction Act of 1995 2013 (Pub. L. 113–5), the HHS
consistent with FDA’s longstanding (44 U.S.C. 3501–3520). The collections Secretary, in consultation with the
commitment to regulatory flexibility of information in 21 CFR parts 312 and Secretary of the U.S. Department of
regarding the evidence required to 314 have been approved under OMB Homeland Security, established the
support drug approval for patient control numbers 0910–0014 and 0910– NACCD. The purpose of the NACCD is
populations with serious disease and 0001, respectively. to provide advice and consultation to
limited or no treatment options, while the HHS Secretary with respect to the
meeting appropriate standards for safety III. Electronic Access
medical and public health needs of
and effectiveness (see, for example, 21 Persons with access to the Internet children in relation to disasters.
CFR 312, subpart E, Drugs Intended to may obtain the document at either Background: The NACCD public
Treat Life-threatening and Severely- https://www.fda.gov/Drugs/ meeting on September 7, 2017, is
debilitating Illnesses). GuidanceCompliance dedicated to the deliberation and vote
This guidance finalizes the draft RegulatoryInformation/Guidances/ on the Human Services Working Group
guidance of the same name issued July default.htm or https:// Report. We will post modifications to
2, 2013 (78 FR 39737). After www.regulations.gov. the agenda on the NACCD September 7,
consideration of comments received in Dated: July 27, 2017. 2017 meeting Web page, which is
response to the draft guidance, FDA located at https://www.phe.gov/naccd.
Anna K. Abram,
updated the guidance to include Availability of Materials: We will post
clarifications about trial designs for Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
all meeting materials prior to the
streamlined development programs and meeting on the NACCD September 7,
[FR Doc. 2017–16228 Filed 8–1–17; 8:45 am]
statistical approaches. In addition, the 2017 meeting Web page located at
guidance outlines development BILLING CODE 4164–01–P
https://www.phe.gov/naccd.
approaches for antibacterial drugs that Procedures for Providing Public Input:
are pathogen-focused (i.e., drugs that are Members of the public attend by
intended to treat a single species or a DEPARTMENT OF HEALTH AND
teleconference via a toll-free call-in
few species of bacteria) and, HUMAN SERVICES
phone number, which is available on
accordingly, fulfills the requirements of Meeting of the National Advisory the NACCD Web site at http://
section 806(a), Title VIII (entitled Committee on Children and Disasters www.phe.gov/naccd.
‘‘Generating Antibiotic Incentives We encourage members of the public
Now’’) of the Food and Drug AGENCY: Office of the Secretary, to provide written comments that are
Administration Safety and Innovation Department of Health and Human relevant to the NACCD teleconference
Act (Pub. L. 112–144). Services. prior to September 7, 2017. Send
FDA notes that section 3042 of the ACTION: Notice. written comments by email via the
21st Century Cures Act (Pub. L. 114– ‘‘Contact Us’’ link on https://
255), which establishes a limited SUMMARY: As stipulated by the Federal www.phe.gov/naccd with ‘‘NACCD
population pathway for certain Advisory Committee Act, the Public Comment’’ in the subject line.
antibacterial and antifungal drugs Department of Health and Human The NACCD will respond to comments
(LPAD) that are intended to treat a Services (HHS) is hereby giving notice received by close-of-business September
serious or life-threatening infection in a that the National Advisory Committee 7, 2017, during the meeting.
limited population of patients with on Children and Disasters (NACCD) will
Dated: July 13, 2017.
unmet needs, was enacted shortly before hold a public meeting on September 7,
publication of this guidance. Some 2017. George W. Korch Jr.,
antibacterial drugs that are candidates DATES: The NACCD meeting is
Acting Assistant Secretary for Preparedness
for a streamlined development program and Response.
September 7, 2017, from 3:00 p.m. to
may also be candidates for LPAD. FDA [FR Doc. 2017–15853 Filed 8–1–17; 8:45 am]
4:00 p.m. EST.
intends to issue separate guidance ADDRESSES: We encourage members of
BILLING CODE P
regarding LPAD. Sponsors are the public to attend the teleconference.
encouraged to discuss proposed To register, go to https://www.phe.gov/
approaches with the Division of Anti- DEPARTMENT OF HEALTH AND
naccd and click on the Contact Us link HUMAN SERVICES
Infective Products. to open the Contact NACCD form, and
This guidance is being issued then fill out the form with NACCD Solicitation of Nominations for
consistent with FDA’s good guidance Registration in the subject line. Submit Membership on the Secretary’s
practices regulation (21 CFR 10.115). your comments on the NACCD Contact Advisory Committee on Human
The guidance represents the current Form located at https://www.phe.gov/ Research Protections
thinking of FDA on this topic. It does NACCDComments.
not establish any rights for any person AGENCY: Office of the Assistant
and is not binding on FDA or the public. FOR FURTHER INFORMATION CONTACT: CDR Secretary for Health, Office for Human
You can use an alternative approach if Evelyn Seel, (202) 205–7960, Research Protections, Office of the
it satisfies the requirements of the evelyn.seel@hhs.gov. Visit the NACCD Secretary, Department of Health and
Web site located at https://
sradovich on DSKBCFCHB2PROD with NOTICES
applicable statutes and regulations. This Human Services.
is not a significant regulatory action www.phe.gov/naccd.
ACTION: Notice.
subject to Executive Order 12866. SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act SUMMARY: The Office for Human
II. The Paperwork Reduction Act of (FACA) of 1972 (5 U.S.C., Appendix, as Research Protections (OHRP), a program
1995 amended), and section 2811A of the office in the Office of the Assistant
This guidance refers to previously Public Health Service (PHS) Act (42 Secretary for Health, Department of
approved collections of information that U.S.C. 300hh–10a), as added by section Health and Human Services (HHS), is
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![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35975
seeking nominations of qualified may include, but are not limited to, a consideration for membership on HHS
candidates to be considered for review of assurance systems, the Federal advisory committees.
appointment as members of the application of minimal research risk Appointment to this Committee shall be
Secretary’s Advisory Committee on standards, the granting of waivers, made without discrimination on the
Human Research Protections (SACHRP). education programs sponsored by basis of age, race, ethnicity, gender,
SACHRP provides advice and OHRP, and the ongoing monitoring and sexual orientation, disability, and
recommendations to the Secretary, HHS oversight of institutional review boards cultural, religious, or socioeconomic
(Secretary), through the Assistant and the institutions that sponsor status.
Secretary for Health, on matters research. Individuals who are selected to be
pertaining to the continuance and Nominations: The OHRP is requesting considered for appointment will be
improvement of functions within the nominations to fill four positions for required to provide detailed information
authority of HHS directed toward voting members of SACHRP. One regarding their financial holdings,
protections for human subjects in position will become vacant in January consultancies, and research grants or
research. SACHRP was established by 2018, with three others becoming vacant contracts. Disclosure of this information
the Secretary on October 1, 2002. OHRP in October 2018. Nominations of is necessary in order to determine if the
is seeking nominations of qualified potential candidates for consideration selected candidate is involved in any
candidates to fill four positions on the are being sought from a wide array of activity that may pose a potential
Committee membership that will be fields, including, but not limited to: conflict with the official duties to be
vacated during the 2018 calendar year. public health and medicine, behavioral performed as a member of SACHRP.
DATES: Nominations for membership on and social sciences, health
the Committee must be received no later administration, and biomedical ethics. Authority: 42 U.S.C. 217a, Section 222 of
To qualify for consideration of the Public Health Service Act, as amended.
than September 18, 2017.
appointment to the Committee, an The Committee is governed by the provisions
ADDRESSES: Nominations should be of Public Law 92–463, as amended (5 U.S.C.
mailed or delivered to Dr. Jerry individual must possess demonstrated
Appendix 2), which sets forth standards for
Menikoff, Director, Office for Human experience and expertise in any of the the formation and use of advisory
Research Protections, Department of several disciplines and fields pertinent committees.
Health and Human Services, 1101 to human subjects protection and/or
Dated: July 26, 2017.
Wootton Parkway, Suite 200, Rockville, clinical research.
The individuals selected for Julia Gorey,
MD 20852. Nominations will not be Executive Director, Secretary’s Advisory
accepted by email or by facsimile. appointment to the Committee can be
invited to serve a term of up to four Committee on Human Research Protections,
FOR FURTHER INFORMATION CONTACT: Julia Office for Human Research Protections
years. Committee members receive a
Gorey, Executive Director, SACHRP, [FR Doc. 2017–16156 Filed 8–1–17; 8:45 am]
stipend and reimbursement for per diem
Office for Human Research Protections,
and any travel expenses incurred for BILLING CODE 4150–36–P
1101 Wootton Parkway, Suite 200,
attending Committee meetings and/or
Rockville, MD 20852, telephone: 240–
conducting other business in the
453–8141. A copy of the Committee DEPARTMENT OF HEALTH AND
interest of the Committee. Interested
charter and list of the current members HUMAN SERVICES
applicants may self-nominate.
can be obtained by contacting Ms. Nominations should be typewritten.
Gorey, accessing the SACHRP Web site The following information should be National Institutes of Health
at www.hhs.gov/ohrp/sachrp, or included in the package of material
requesting via email at sachrp@ National Institute of Diabetes and
submitted for each individual being
osophs.dhhs.gov. Digestive and Kidney Diseases; Notice
nominated for consideration: (1) A letter
of Meetings
SUPPLEMENTARY INFORMATION: The of nomination that clearly states the
Committee provides advice on matters name and affiliation of the nominee, the Pursuant to section 10(d) of the
pertaining to the continuance and basis for the nomination (i.e., specific Federal Advisory Committee Act, as
improvement of functions within the attributes which qualify the nominee for amended (5 U.S.C. App.), notice is
authority of HHS directed toward service in this capacity), and a statement hereby given of meetings of the National
protections for human subjects in that the nominee is willing to serve as Diabetes and Digestive and Kidney
research. Specifically, the Committee a member of the Committee; (2) the Diseases Advisory Council.
provides advice relating to the nominator’s name, address, daytime The meetings will be open to the
responsible conduct of research telephone number, and the home and/ public as indicated below, with
involving human subjects with or work address, telephone number, and attendance limited to space available.
particular emphasis on special email address of the individual being Individuals who plan to attend and
populations such as neonates and nominated; and (3) a current copy of the need special assistance, such as sign
children, prisoners, the decisionally nominee’s curriculum vitae. Federal language interpretation or other
impaired, pregnant women, embryos employees should not be nominated for reasonable accommodations, should
and fetuses, individuals and consideration of appointment to this notify the Contact Person listed below
populations in international studies, Committee. in advance of the meeting.
investigator conflicts of interest and The Department makes every effort to The meetings will be closed to the
populations in which there are ensure that the membership of HHS public in accordance with the
Federal advisory committees is fairly provisions set forth in sections
sradovich on DSKBCFCHB2PROD with NOTICES
individually identifiable samples, data
or information. balanced in terms of points of view 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
In addition, the Committee is represented and the committee’s as amended. The grant applications and
responsible for reviewing selected function. Every effort is made to ensure the discussions could disclose
ongoing work and planned activities of that individuals from a broad confidential trade secrets or commercial
the OHRP and other offices/agencies representation of geographic areas, property such as patentable material,
within HHS responsible for human women and men, ethnic and minority and personal information concerning
subjects protection. These evaluations groups, and the disabled are given individuals associated with the grant
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Document Created: 2017-08-02 07:09:38
Document Modified: 2017-08-02 07:09:38
| 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 | Nominations for membership on the Committee must be received no later than September 18, 2017. | |
| Contact | Julia Gorey, Executive Director, SACHRP, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, telephone: 240-453-8141. A copy of the Committee charter and list of the current members can be obtained by contacting Ms. Gorey, accessing the SACHRP Web site at www.hhs.gov/ ohrp/sachrp, or requesting via email at [email protected] | |
| FR Citation | 82 FR 35974 |
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