82 FR 57463 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 232 (December 5, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 232 (December 5, 2017)
| Page Range | 57463-57464 | |
| FR Document | 2017-26189 |
[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)] [Notices] [Pages 57463-57464] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26189] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as [[Page 57464]] amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member conflict: AIDS and AIDS Related Research. Date: December 12, 2017 Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301-451-8754, [email protected]. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Applications. Date: December 13, 2017. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Barna Dey, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, Bethesda, MD 20892, 301-451-2796, [email protected]. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 30, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017-26189 Filed 12-4-17; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices 57463
from the Internet. See the process validation and verification Guidance documents are also available
SUPPLEMENTARY INFORMATION section for methods for these devices. To discuss at https://www.fda.gov/BiologicsBlood
information on electronic access to the these challenges and obtain initial Vaccines/GuidanceCompliance
guidance. Submit written requests for a stakeholder input, the FDA held a RegulatoryInformation/default.htm or
single hard copy of the guidance public workshop entitled ‘‘Additive https://www.regulations.gov. Persons
document entitled ‘‘Technical Manufacturing of Medical Devices: An unable to download an electronic copy
Considerations for Additive Interactive Discussion on the Technical of ‘‘Technical Considerations for
Manufactured Devices; Guidance for Considerations of 3D Printing,’’ on Additive Manufactured Medical
Industry and Food and Drug October 8–9, 2014 (79 FR 28732). Devices; Guidance for Industry and
Administration Staff’’ to the Office of This guidance is a leapfrog guidance; Food and Drug Administration Staff’’
the Center Director, Guidance and leapfrog guidances are intended to serve may send an email request to CDRH-
Policy Development, Center for Devices as a mechanism by which the Agency Guidance@fda.hhs.gov to receive an
and Radiological Health, Food and Drug can share initial thoughts regarding the electronic copy of the document. Please
Administration, 10903 New Hampshire content of premarket submissions for use the document number 1400002 to
Ave., Bldg. 66, Rm. 5431, Silver Spring, emerging technologies and new clinical identify the guidance you are
MD 20993–0002 or the Office of applications that are likely to be of requesting.
Communication, Outreach, and public health importance very early in
product development. This leapfrog IV. Paperwork Reduction Act of 1995
Development, Center for Biologics
Evaluation and Research, Food and guidance represents the Agency’s initial This guidance refers to previously
Drug Administration, 10903 New thinking, and our recommendations approved collections of information
Hampshire Ave., Bldg. 71, Rm. 3128, may change as more information found in FDA regulations. These
Silver Spring, MD 20993–0002. Send becomes available. The Agency strongly collections of information are subject to
one self-addressed adhesive label to encourages manufacturers to engage review by the Office of Management and
assist that office in processing your with CDRH and/or CBER through the Budget (OMB) under the Paperwork
request. Pre-Submission process to obtain more Reduction Act of 1995 (44 U.S.C. 3501–
FOR FURTHER INFORMATION CONTACT:
detailed feedback regarding their AM 3520). The collections of information in
Matthew Di Prima, Center for Devices device or process. For more information 21 CFR part 801 have been approved
and Radiological Health, Food and Drug on Pre-Submissions, please see under OMB control number 0910–0485;
Administration, 10903 New Hampshire ‘‘Requests for Feedback on Medical the collections of information in 21 CFR
Ave., Bldg. 62, Rm. 2214, Silver Spring, Device Submissions: The Pre- part 807, subpart E, have been approved
MD 20993–0002, 301–796–2507 or Submission Program and Meetings with under OMB control number 0910–0120;
Stephen Ripley, Center for Biologics Food and Drug Administration Staff’’ the collections of information in 21 CFR
Evaluation and Research, Food and (https://www.fda.gov/downloads/ part 812 have been approved under
Drug Administration, 10903 New MedicalDevices/DeviceRegulation OMB control number 0910–0078; the
Hampshire Ave., Bldg. 71, Rm. 7301, andGuidance/GuidanceDocuments/ collections of information in 21 CFR
Silver Spring, MD 20993, 240–402– UCM311176.pdf). part 814, subparts A through E have
The FDA considered comments been approved under OMB control
7911.
received on the draft guidance that number 0910–0231; the collections of
SUPPLEMENTARY INFORMATION: appeared in the Federal Register of May information in 21 CFR part 814, subpart
I. Background 10, 2016 (81 FR 28876). FDA has revised H have been approved under OMB
the guidance as appropriate in response control number 0910–0332; and the
FDA has developed this leapfrog to the comments. collections of information in 21 CFR
guidance to provide FDA’s initial
II. Significance of Guidance part 820 have been approved under
thoughts on technical considerations
OMB control number 0910–0073. The
specific to devices using additive This guidance is being issued collections of information in the
manufacturing (AM), the broad category consistent with FDA’s good guidance guidance document ‘‘Requests for
of manufacturing encompassing 3D practices regulation (21 CFR 10.115). Feedback on Medical Device
printing. In medical device applications, The guidance represents the current Submissions: The Pre-Submission
AM has the advantage of facilitating the thinking of FDA on ‘‘Technical Program and Meetings with Food and
creation of anatomically-matched Considerations for Additive Drug Administration Staff’’ have been
devices and surgical instrumentation by Manufactured Medical Devices.’’ It does approved under OMB control number
using a patient’s own medical imaging. not establish any rights for any person 0910–0756.
Another advantage is the ease in and is not binding on FDA or the public.
fabricating complex geometric Dated: November 30, 2017.
You can use an alternative approach if
structures, allowing the creation of it satisfies the requirements of the Leslie Kux,
engineered open lattice structures, applicable statutes and regulations. This Associate Commissioner for Policy.
tortuous internal channels, and internal guidance is not subject to Executive [FR Doc. 2017–26196 Filed 12–4–17; 8:45 am]
support structures that would not be Order 12866. BILLING CODE 4164–01–P
easily possible using traditional (non-
additive) manufacturing approaches. III. Electronic Access
However, the unique aspects of the AM Persons interested in obtaining a copy DEPARTMENT OF HEALTH AND
process, such as the layer-by-layer of the guidance may do so by HUMAN SERVICES
sradovich on DSK3GMQ082PROD with NOTICES
fabrication process, and the relative lack downloading an electronic copy from
of experience and clinical history of the internet. A search capability for all National Institutes of Health
with respect to devices manufactured Center for Devices and Radiological
Center for Scientific Review; Notice of
using AM techniques, pose challenges Health guidance documents is available
Closed Meetings
in determining optimal characterization at https://www.fda.gov/MedicalDevices/
and assessment methods for the final DeviceRegulationandGuidance/ Pursuant to section 10(d) of the
finished device, as well as optimal GuidanceDocuments/default.htm. Federal Advisory Committee Act, as
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![57464 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices
amended, notice is hereby given of the DEPARTMENT OF HEALTH AND LA), as a commercial gauger and
following meetings. HUMAN SERVICES laboratory.
The meetings will be closed to the
public in accordance with the National Institutes of Health SUMMARY: Notice is hereby given,
provisions set forth in sections pursuant to CBP regulations, that
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institute on Aging; Notice of
Closed Meeting AmSpec LLC (Destrehan, LA), has been
as amended. The grant applications and approved to gauge petroleum and
the discussions could disclose Pursuant to section 10(d) of the certain petroleum products and
confidential trade secrets or commercial Federal Advisory Committee Act, as accredited to test petroleum and certain
property such as patentable material, amended, notice is hereby given of the
and personal information concerning petroleum products for customs
following meeting. purposes for the next three years as of
individuals associated with the grant The meeting will be closed to the
applications, the disclosure of which June 15, 2017.
public in accordance with the
would constitute a clearly unwarranted provisions set forth in sections DATES: AmSpec LLC (Destrehan, LA)
invasion of personal privacy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., was approved and accredited as a
Name of Committee: Center for Scientific as amended. The grant applications and commercial gauger and laboratory as of
Review Special Emphasis Panel; Member the discussions could disclose June 15, 2017. The next triennial
conflict: AIDS and AIDS Related Research. confidential trade secrets or commercial inspection date will be scheduled for
Date: December 12, 2017 property such as patentable material,
Time: 1:00 p.m. to 5:00 p.m.
June 2020.
and personal information concerning
Agenda: To review and evaluate grant FOR FURTHER INFORMATION CONTACT:
applications.
individuals associated with the grant
applications, the disclosure of which Christopher J. Mocella, Laboratories and
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892 would constitute a clearly unwarranted Scientific Services Directorate, U.S.
(Telephone Conference Call). invasion of personal privacy. Customs and Border Protection, 1300
Contact Person: Jingsheng Tuo, Ph.D., Name of Committee: National Institute on Pennsylvania Avenue NW., Suite
Scientific Review Officer, Center for Aging Special Emphasis Panel; Collaborative 1500N, Washington, DC 20229, tel. 202–
Scientific Review, National Institutes of Muscle and Aging Study. 344–1060.
Health, 6701 Rockledge Drive, Room 5207, Date: January 17, 2018.
Bethesda, MD 20892, 301–451–8754, tuoj@ Time: 2:00 p.m. to 5:00 p.m. SUPPLEMENTARY INFORMATION: Notice is
nei.nih.gov. Agenda: To review and evaluate grant hereby given pursuant to 19 CFR 151.12
This notice is being published less than 15 applications. and 19 CFR 151.13, that AmSpec LLC,
days prior to the meeting due to the timing Place: National Institute on Aging, 14682 Airline Hwy., Destrehan, LA
limitations imposed by the review and Gateway Building, 2C212, 7201 Wisconsin
funding cycle. 70047, has been approved to gauge
Avenue, Bethesda, MD 20892 (Telephone
Name of Committee: Center for Scientific Conference Call). petroleum and certain petroleum
Review Special Emphasis Panel; Member Contact Person: Anita H. Undale, Ph.D., products and accredited to test
Conflict: AIDS and AIDS Related M.D., Scientific Review Branch, National petroleum and certain petroleum
Applications. Institute on Aging, Gateway Building, Suite products for customs purposes, in
Date: December 13, 2017. 2W200, 7201 Wisconsin Avenue, Bethesda, accordance with the provisions of 19
Time: 10:00 a.m. to 6:00 p.m. MD 20892, 240–747–7825, anita.undale@
nih.gov. CFR 151.12 and 19 CFR 151.13. AmSpec
Agenda: To review and evaluate grant
applications. (Catalogue of Federal Domestic Assistance
LLC is approved for the following
Place: National Institutes of Health, 6701 Program Nos. 93.866, Aging Research, gauging procedures for petroleum and
Rockledge Drive, Bethesda, MD 20892 National Institutes of Health, HHS) certain petroleum products from the
(Virtual Meeting). American Petroleum Institute (API):
Contact Person: Barna Dey, Ph.D., Dated: November 29, 2017.
Scientific Review Officer, Center for Melanie J. Pantoja,
API chapters Title
Scientific Review, National Institutes of Program Analyst, Office of Federal Advisory
Health, 6701 Rockledge Drive, Room 3184, Committee Policy. 3 ..................... Tank Gauging.
Bethesda, MD 20892, 301–451–2796, bdey@ [FR Doc. 2017–26190 Filed 12–4–17; 8:45 am]
mail.nih.gov. 7 ..................... Temperature Determination.
BILLING CODE 4140–01–P 8 ..................... Sampling.
This notice is being published less than 15
days prior to the meeting due to the timing 12 ................... Calculations.
limitations imposed by the review and 17 ................... Maritime Measurement.
funding cycle. DEPARTMENT OF HOMELAND
(Catalogue of Federal Domestic Assistance SECURITY AmSpec LLC is accredited for the
Program Nos. 93.306, Comparative Medicine; following laboratory analysis
93.333, Clinical Research; 93.306, 93.333, U.S. Customs and Border Protection
procedures and methods for petroleum
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National Accreditation and Approval of AmSpec and certain petroleum products set forth
Institutes of Health, HHS) LLC (Destrehan, LA) as a Commercial by the U.S. Customs and Border
Dated: November 30, 2017. Gauger and Laboratory Protection Laboratory Methods (CBPL)
and American Society for Testing and
Melanie J. Pantoja, AGENCY: U.S. Customs and Border
Materials (ASTM):
Program Analyst, Office of Federal Advisory Protection, Department of Homeland
sradovich on DSK3GMQ082PROD with NOTICES
Committee Policy. Security.
[FR Doc. 2017–26189 Filed 12–4–17; 8:45 am] ACTION: Notice of accreditation and
BILLING CODE 4140–01–P approval of AmSpec LLC (Destrehan,
CBPL No. ASTM Title
27–03 .............. D4006 Standard Test Method for Water in Crude Oil by Distillation.
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Document Created: 2017-12-04 23:44:50
Document Modified: 2017-12-04 23:44:50
| 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 | |
| Dates | December 12, 2017 | |
| FR Citation | 82 FR 57463 |
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