80 FR 48886 - Systematic Review of Immunotoxicity Associated With Exposure to PFOA or PFOS; Request for Information and Nominations of Scientific Experts for Proposed Peer Review Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 157 (August 14, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 157 (August 14, 2015)
| Page Range | 48886-48887 | |
| FR Document | 2015-20122 |
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)] [Notices] [Pages 48886-48887] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20122] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Systematic Review of Immunotoxicity Associated With Exposure to PFOA or PFOS; Request for Information and Nominations of Scientific Experts for Proposed Peer Review Meeting SUMMARY: The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences is evaluating the scientific evidence regarding the association between exposures to perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) and immunotoxicity. OHAT invites the submission of information about ongoing studies or upcoming publications on the immune-related health effects of PFOA or PFOS that might be considered for inclusion in the evaluation. OHAT also invites the nomination of scientific experts to potentially serve as members of an ad hoc expert panel to be convened to peer review the draft NTP monograph resulting from the systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity. DATES: The deadline for receipt of information and nominations of scientific experts is September 30, 2015. ADDRESSES: Information can be submitted to [email protected]. FOR FURTHER INFORMATION CONTACT: Dr. Yun Xie, NTP Designated Federal Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541- 3436, Fax: (301) 451-5455, Email: [email protected]. Hand Delivery/ Courier: 530 Davis Drive, Room 2161, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background on PFOA and PFOS: PFOA and PFOS are persistent chemicals that are widely distributed in the environment in part because of high stability and little to no expected degradation in the environment. In terms of toxicity and exposure, PFOA and PFOS are the best studied perfluoroalkyl acids, a group of compounds used extensively over the last 50 years in commercial and industrial applications including food packaging, lubricants, water-resistant coatings, and fire-retarding foams. Through voluntary agreements, the primary manufacturer of PFOS phased out production in 2002, and PFOS is no longer manufactured in the United States. Similar arrangements have been made for PFOA, and eight companies that manufacture PFOA have committed to eliminate emissions and product content by 2015. Although emissions have been dramatically reduced, the persistence and bioaccumulation of both PFOA and PFOS result in detectable levels in the U.S. population and, therefore, these chemicals are of potential human health relevance. Several recent publications from 2012-2014 have linked PFOA and PFOS exposure to functional immune changes in humans, which are consistent with evidence of PFOA- and PFOS-related immunotoxicity in animal studies. NTP is conducting a systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity or immune-related health effects. The NTP evaluation concept for immunotoxicity associated with exposure to PFOA or PFOS was initially presented and discussed at the NTP Board of Scientific Counselors (BSC) meeting on December 10, 2014 (79 FR 62640). The NTP evaluation concept, related presentation, and BSC meeting minutes are available at http://ntp.niehs.nih.gov/go/9741. The protocol for conducting this systematic review is available at http://ntp.niehs.nih.gov/go/749926. Request for Information: OHAT invites the public and other interested parties to submit information on PFOA and PFOS including immune-related effects from completed and ongoing epidemiology studies, non-human animal studies, and mechanistic or in vitro studies. This information will be considered in evaluating the potential immune- related health effects of exposure to PFOA and PFOS. Information should be submitted to Dr. Yun Xie (see ADDRESSES). Request for Nomination of Scientific Experts: OHAT invites nominations of qualified scientists to serve as members of an ad hoc expert panel to peer review the draft NTP monograph resulting from the systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity. Scientists serving on the peer review panel will represent a wide range of expertise including, but not limited to, epidemiology, immunotoxicology, general toxicology, exposure assessment, and biostatistics. Each nomination should include (1) contact information for the nominee (name, affiliation, telephone number, and email), (2) curriculum vitae, and (3) a short description of the individual's expertise such as formal academic training and experience in a relevant scientific field, publications in peer- [[Page 48887]] reviewed journals, and membership in relevant professional societies. Nominations should be forwarded to Dr. Yun Xie (see ADDRESSES). Final selection of individuals to serve on the peer review panel will be made in accordance with the Federal Advisory Committee Act and Department of Health and Human Services implementing regulations. All panel members serve as individual experts and not as representatives of their employers or other organizations. Background Information on OHAT: OHAT was established to serve as an environmental health resource to the public and regulatory and health agencies (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3094430). This office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as ``substances'') cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels. OHAT also organizes workshops or state- of-the-science evaluations to address issues of importance in environmental health sciences. Information about OHAT is found at http://ntp.niehs.nih.gov/go/ohat. Dated: August 11, 2015. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2015-20122 Filed 8-13-15; 8:45 am] BILLING CODE 4140-01-P
![48886 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
(Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND States. Similar arrangements have been
Program Nos. 93.866, Aging Research, HUMAN SERVICES made for PFOA, and eight companies
National Institutes of Health, HHS) that manufacture PFOA have committed
National Institutes of Health to eliminate emissions and product
Dated: August 11, 2015.
content by 2015. Although emissions
Melanie J. Gray, Systematic Review of Immunotoxicity have been dramatically reduced, the
Program Analyst, Office of Federal Advisory Associated With Exposure to PFOA or persistence and bioaccumulation of both
Committee Policy. PFOS; Request for Information and PFOA and PFOS result in detectable
[FR Doc. 2015–20099 Filed 8–13–15; 8:45 am] Nominations of Scientific Experts for levels in the U.S. population and,
BILLING CODE 4140–01–P Proposed Peer Review Meeting therefore, these chemicals are of
SUMMARY: The Office of Health potential human health relevance.
Assessment and Translation (OHAT), Several recent publications from 2012–
DEPARTMENT OF HEALTH AND 2014 have linked PFOA and PFOS
HUMAN SERVICES Division of the National Toxicology
Program (DNTP), National Institute of exposure to functional immune changes
National Institutes of Health Environmental Health Sciences is in humans, which are consistent with
evaluating the scientific evidence evidence of PFOA- and PFOS-related
Eunice Kennedy Shriver National regarding the association between immunotoxicity in animal studies.
Institute of Child Health and Human NTP is conducting a systematic
exposures to perfluorooctanoic acid
Development; Notice of Closed review of the evidence for an
(PFOA) or perfluorooctane sulfonate
Meeting association between exposure to PFOA
(PFOS) and immunotoxicity. OHAT or PFOS and immunotoxicity or
Pursuant to section 10(d) of the invites the submission of information immune-related health effects. The NTP
Federal Advisory Committee Act, as about ongoing studies or upcoming evaluation concept for immunotoxicity
amended (5 U.S.C. App.), notice is publications on the immune-related associated with exposure to PFOA or
hereby given of the following meeting. health effects of PFOA or PFOS that PFOS was initially presented and
The meeting will be closed to the might be considered for inclusion in the discussed at the NTP Board of Scientific
public in accordance with the evaluation. OHAT also invites the Counselors (BSC) meeting on December
provisions set forth in section 552b(c)(4) nomination of scientific experts to 10, 2014 (79 FR 62640). The NTP
and 552b(c)(6), Title 5 U.S.C., as potentially serve as members of an ad evaluation concept, related
amended. The grant applications and hoc expert panel to be convened to peer presentation, and BSC meeting minutes
the discussions could disclose review the draft NTP monograph are available at http://ntp.niehs.nih.gov/
confidential trade secrets or commercial resulting from the systematic review of go/9741. The protocol for conducting
property such as patentable material, the evidence for an association between this systematic review is available at
and personal information concerning exposure to PFOA or PFOS and http://ntp.niehs.nih.gov/go/749926.
individuals associated with the grant immunotoxicity. Request for Information: OHAT
applications, the disclosure of which DATES: The deadline for receipt of invites the public and other interested
would constitute a clearly unwarranted information and nominations of parties to submit information on PFOA
invasion of personal privacy. scientific experts is September 30, 2015. and PFOS including immune-related
Name of Committee: National Institute of ADDRESSES: Information can be effects from completed and ongoing
Child Health and Human Development Initial submitted to xiey4@niehs.nih.gov. epidemiology studies, non-human
Review Group; Health, Behavior, and Context animal studies, and mechanistic or in
FOR FURTHER INFORMATION CONTACT: Dr.
Subcommittee. vitro studies. This information will be
Date: October 26, 2015. Yun Xie, NTP Designated Federal considered in evaluating the potential
Time: 8:00 a.m. to 5:00 p.m. Official, Office of Liaison, Policy and immune-related health effects of
Agenda: To review and evaluate grant Review, DNTP, NIEHS, P.O. Box 12233, exposure to PFOA and PFOS.
applications. MD K2–03, Research Triangle Park, NC Information should be submitted to Dr.
Place: Hyatt Regency Bethesda, One 27709. Phone: (919) 541–3436, Fax:
Bethesda Metro Center, 7400 Wisconsin Yun Xie (see ADDRESSES).
(301) 451–5455, Email: yun.xie@nih.gov. Request for Nomination of Scientific
Avenue, Bethesda, MD 20814. Hand Delivery/Courier: 530 Davis Drive,
Contact Person: Priscah Mujuru, DRPH, Experts: OHAT invites nominations of
MPH, Scientific Review Officer, Scientific
Room 2161, Morrisville, NC 27560. qualified scientists to serve as members
Review Branch, Eunice Kennedy Shriver SUPPLEMENTARY INFORMATION: of an ad hoc expert panel to peer review
National Institute of Child Health and Background on PFOA and PFOS: the draft NTP monograph resulting from
Human Development, NIH, 6100 Executive PFOA and PFOS are persistent the systematic review of the evidence
Boulevard, Room 5B01, Bethesda, MD chemicals that are widely distributed in for an association between exposure to
20892–9304, (301) 435–6908, the environment in part because of high PFOA or PFOS and immunotoxicity.
mujurup@mail.nih.gov.
stability and little to no expected Scientists serving on the peer review
(Catalogue of Federal Domestic Assistance degradation in the environment. In panel will represent a wide range of
Program Nos. 93.864, Population Research;
terms of toxicity and exposure, PFOA expertise including, but not limited to,
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation and PFOS are the best studied epidemiology, immunotoxicology,
Research; 93.209, Contraception and perfluoroalkyl acids, a group of general toxicology, exposure
compounds used extensively over the assessment, and biostatistics. Each
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Infertility Loan Repayment Program, National
Institutes of Health, HHS) last 50 years in commercial and nomination should include (1) contact
industrial applications including food information for the nominee (name,
Dated: August 11, 2015. packaging, lubricants, water-resistant affiliation, telephone number, and
Michelle Trout, coatings, and fire-retarding foams. email), (2) curriculum vitae, and (3) a
Program Analyst, Office of Federal Advisory Through voluntary agreements, the short description of the individual’s
Committee Policy. primary manufacturer of PFOS phased expertise such as formal academic
[FR Doc. 2015–20102 Filed 8–13–15; 8:45 am] out production in 2002, and PFOS is no training and experience in a relevant
BILLING CODE 4140–01–P longer manufactured in the United scientific field, publications in peer-
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![Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48887
reviewed journals, and membership in Agenda: To discuss program policies and the discussions could disclose
relevant professional societies. issues. confidential trade secrets or commercial
Nominations should be forwarded to Dr. Place: National Institutes of Health, property such as patentable material,
Building 35A, Porter Building, Room 640,
Yun Xie (see ADDRESSES). Final and personal information concerning
35A Convent Drive, Bethesda, MD 20892.
selection of individuals to serve on the Contact Person: Stephen C. Mockrin, Ph.D., individuals associated with the grant
peer review panel will be made in Director, Division of Extramural Research applications, the disclosure of which
accordance with the Federal Advisory Activities National Heart, Lung, and Blood would constitute a clearly unwarranted
Committee Act and Department of Institute, National Institutes of Health, 6701 invasion of personal privacy.
Health and Human Services Rockledge Drive, Room 7100, Bethesda, MD Name of Committee: National Institute of
implementing regulations. All panel 20892 (301) 435–0260 mockrins@ Child Health and Human Development
members serve as individual experts nhlbi.nih.gov. Special, Emphasis Panel; Comparative and
and not as representatives of their This notice is being published less than 15 Developmental Perspectives on the
employers or other organizations. days prior to the meeting due to internal Emergence of Cognitive Competence.
Background Information on OHAT: discussions regarding agenda and scheduling Date: August 31, 2015.
OHAT was established to serve as an details. Time: 9:30 a.m. to 12:30 p.m.
Any interested person may file written Agenda: To review and evaluate grant
environmental health resource to the comments with the committee by forwarding applications.
public and regulatory and health the statement to the Contact Person listed on Place: National Institutes of Health, 6100
agencies (http://www.ncbi.nlm.nih.gov/ this notice. The statement should include the Executive Boulevard, Rockville, MD 20852,
pmc/articles/PMC3094430). This office name, address, telephone number and when (Telephone Conference Call).
conducts evaluations to assess the applicable, the business or professional Contact Person: Marita R. Hopmann, Ph.D.,
evidence that environmental chemicals, affiliation of the interested person. Scientific Review Officer, Scientific Review
physical substances, or mixtures In the interest of security, NIH has Branch, Eunice Kennedy Shriver National
(collectively referred to as ‘‘substances’’) instituted stringent procedures for entrance Institute of Child Health and Human
cause adverse health effects and onto the NIH campus. All visitor vehicles, Development, NIH, 6100 Executive
including taxicabs, hotel, and airport shuttles Boulevard, Room 5B01, Bethesda, MD
provides opinions on whether these will be inspected before being allowed on 20892–9304, (301) 435–6911, hopmannm@
substances may be of concern given campus. Visitors will be asked to show one mail.nih.gov.
what is known about current human form of identification (for example, a (Catalogue of Federal Domestic Assistance
exposure levels. OHAT also organizes government-issued photo ID, driver’s license, Program Nos. 93.864, Population Research;
workshops or state-of-the-science or passport) and to state the purpose of their 93.865, Research for Mothers and Children;
evaluations to address issues of visit. 93.929, Center for Medical Rehabilitation
importance in environmental health Information is also available on the Research; 93.209, Contraception and
sciences. Information about OHAT is Institute’s/Center’s home page: Infertility Loan Repayment Program, National
found at http://ntp.niehs.nih.gov/go/ www.nhlbi.nih.gov/meetings/nhlbac/ Institutes of Health, HHS)
index.htm, where an agenda and any
ohat. additional information for the meeting will Dated: August 10, 2015.
Dated: August 11, 2015. be posted when available. Michelle Trout,
John R. Bucher, (Catalogue of Federal Domestic Assistance Program Analyst, Office of Federal Advisory
Associate Director, National Toxicology Program Nos. 93.233, National Center for Committee Policy.
Program. Sleep Disorders Research; 93.837, Heart and [FR Doc. 2015–19976 Filed 8–13–15; 8:45 am]
[FR Doc. 2015–20122 Filed 8–13–15; 8:45 am] Vascular Diseases Research; 93.838, Lung
BILLING CODE 4140–01–P
Diseases Research; 93.839, Blood Diseases
BILLING CODE 4140–01–P
and Resources Research, National Institutes
of Health, HHS)
Dated: August 11, 2015.
DEPARTMENT OF HOMELAND
DEPARTMENT OF HEALTH AND SECURITY
HUMAN SERVICES Michelle Trout,
Program Analyst, Office of Federal Advisory Coast Guard
National Institutes of Health Committee Policy.
[Docket No. USCG–2015–0673]
[FR Doc. 2015–20119 Filed 8–13–15; 8:45 am]
National Heart, Lung, and Blood
BILLING CODE 4140–01–P Commercial Fishing Safety Advisory
Institute; Notice of Meeting
Committee
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND AGENCY: Coast Guard, Department of
amended (5 U.S.C. App.), notice is HUMAN SERVICES Homeland Security.
hereby given of a meeting of the ACTION: Notice of Federal Advisory
National Heart, Lung, and Blood National Institutes of Health Committee Meeting.
Advisory Council. Eunice Kennedy Shriver National
The meeting will be open to the SUMMARY: The Commercial Fishing
Institute of Child Health And Human Safety Advisory Committee will meet in
public as indicated below, with
Development; Notice of Closed Seattle, Washington to discuss various
attendance limited to space available.
Meeting issues relating to safety in the
Individuals who plan to attend and
need special assistance, such as sign Pursuant to section 10(d) of the commercial fishing industry. This
asabaliauskas on DSK5VPTVN1PROD with NOTICES
language interpretation or other Federal Advisory Committee Act, as meeting will be open to the public.
reasonable accommodations, should amended (5 U.S.C. App.), notice is DATES: The Committee will meet on
notify the Contact Person listed below hereby given of the following meeting. Tuesday, September 15 and Wednesday,
in advance of the meeting. The meeting will be closed to the September 16, 2015, from 8 a.m. to 5:30
public in accordance with the p.m. The meeting may close early if all
Name of Committee: National Heart, Lung,
and Blood Advisory Council. provisions set forth in section 552b(c)(4) business is finished.
Date: September 2, 2015. and 552b(c)(6), Title 5 U.S.C., as ADDRESSES: The Committee will meet at
Open: 1:30 p.m. to 5:00 p.m. amended. The grant applications and the United States District Court House
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Document Created: 2018-02-23 10:58:46
Document Modified: 2018-02-23 10:58:46
| 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 | |
| Dates | The deadline for receipt of information and nominations of scientific experts is September 30, 2015. | |
| Contact | Dr. Yun Xie, NTP Designated Federal Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541- 3436, Fax: (301) 451-5455, Email: [email protected] Hand Delivery/ Courier: 530 Davis Drive, Room 2161, Morrisville, NC 27560. | |
| FR Citation | 80 FR 48886 |
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