82 FR 49034 - Performance Review Board Members
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 203 (October 23, 2017)
Federal Register Volume 82, Issue 203 (October 23, 2017)
| Page Range | 49034-49035 | |
| FR Document | 2017-22863 |
[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)] [Notices] [Pages 49034-49035] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22863] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons may be named to serve on the Performance Review Boards or Panels, which oversee the evaluation of performance appraisals of Senior Executive Service members of the Department of Health and Human Services. Employee Name Barry, Daniel Barlow, Amanda Coughlin, Janis Fantinato, Jessica Gentile, John Johnson, Jeffrey Katz, Ruth Kretschmaier, Michon Lewis, Lisa McDaniel, Eileen Novy, Steve Sample, Allen Skeadas, Christos Tobias, Constance Weber, Mark [[Page 49035]] Dated: October 16, 2017. Charles H. McEnerney III, Director, Executive and Scientific Resources Division. [FR Doc. 2017-22863 Filed 10-20-17; 8:45 am] BILLING CODE 4151-17-P
![49034 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices
identified, as confidential, if submitted Hampshire Ave., Hillandale Building, guidance practices regulation (21 CFR
as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– 10.115). The new draft guidance, when
Instructions: All submissions received 0002. Send one self-addressed adhesive finalized, will represent the current
must include the Docket No. FDA– label to assist that office in processing thinking of FDA on the design of BE
2007–D–0369 for ‘‘Draft Guidance on your requests. See the SUPPLEMENTARY studies to support ANDAs for
Methylphenidate Hydrochloride.’’ INFORMATION section for electronic methylphenidate hydrochloride oral
Received comments will be placed in access to the draft guidance document. extended-release tablets. It does not
the docket and, except for those FOR FURTHER INFORMATION CONTACT: establish any rights for any person and
submitted as ‘‘Confidential Xiaoqiu Tang, Center for Drug is not binding on FDA or the public.
Submissions,’’ publicly viewable at Evaluation and Research (HFD–600), You can use an alternative approach if
https://www.regulations.gov or at the Food and Drug Administration, 10903 it satisfies the requirements of the
Dockets Management Staff between 9 New Hampshire Ave., Bldg. 75, Rm. applicable statutes and regulations. This
a.m. and 4 p.m., Monday through 4730, Silver Spring, MD 20993–0002, guidance is not subject to Executive
Friday. 301–796–5850. Order 12866.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
submit a comment with confidential II. Electronic Access
information that you do not wish to be I. Background
Persons with access to the internet
made publicly available, submit your In the Federal Register of June 11, may obtain the draft guidance at either
comments only as a written/paper 2010 (75 FR 33311), FDA announced the https://www.fda.gov/Drugs/
submission. You should submit two availability of a guidance for industry GuidanceCompliance
copies total. One copy will include the entitled ‘‘Bioequivalence RegulatoryInformation/Guidances/
information you claim to be confidential Recommendations for Specific default.htm or https://
with a heading or cover note that states Products,’’ which explained the process www.regulations.gov.
‘‘THIS DOCUMENT CONTAINS that would be used to make product-
CONFIDENTIAL INFORMATION.’’ The Dated: October 17, 2017.
specific guidances available to the
Agency will review this copy, including public on FDA’s Web site at https:// Anna K. Abram,
the claimed confidential information, in www.fda.gov/Drugs/ Deputy Commissioner for Policy, Planning,
its consideration of comments. The GuidanceCompliance Legislation, and Analysis.
second copy, which will have the RegulatoryInformation/Guidances/ [FR Doc. 2017–22891 Filed 10–20–17; 8:45 am]
claimed confidential information default.htm. BILLING CODE 4164–01–P
redacted/blacked out, will be available As described in that guidance, FDA
for public viewing and posted on adopted this process to develop and
https://www.regulations.gov. Submit disseminate product-specific guidances DEPARTMENT OF HEALTH AND
both copies to the Dockets Management and to provide a meaningful HUMAN SERVICES
Staff. If you do not wish your name and opportunity for the public to consider
contact information to be made publicly and comment on the guidances. This Performance Review Board Members
available, you can provide this notice announces the availability of a
information on the cover sheet and not Title 5, U.S.C. Section 4314(c)(4) of
new draft guidance for generic the Civil Service Reform Act of 1978,
in the body of your comments and you methylphenidate hydrochloride oral
must identify this information as Public Law 95–454, requires that the
extended-release tablets. appointment of Performance Review
‘‘confidential.’’ Any information marked FDA initially approved new drug
as ‘‘confidential’’ will not be disclosed Board Members be published in the
application 018029 for RITALIN–SR
except in accordance with 21 CFR 10.20 Federal Register. The following persons
(methylphenidate hydrochloride oral
and other applicable disclosure law. For may be named to serve on the
extended-release tablets) in March 1982.
more information about FDA’s posting Performance Review Boards or Panels,
We are now issuing a new draft
of comments to public dockets, see 80 which oversee the evaluation of
guidance for industry on
FR 56469, September 18, 2015, or access methylphenidate hydrochloride oral performance appraisals of Senior
the information at: https://www.gpo.gov/ extended-release tablets (‘‘Draft Executive Service members of the
fdsys/pkg/FR-2015-09-18/pdf/2015- Guidance on Methylphenidate Department of Health and Human
23389.pdf. Hydrochloride’’). Services.
Docket: For access to the docket to In May 2016, KVK-Tech, Inc. (KVK- Employee Name
read background documents or the Tech) submitted a citizen petition
electronic and written/paper comments requesting, among other things, that Barry, Daniel
received, go to https:// FDA not accept for filing any new Barlow, Amanda
www.regulations.gov and insert the ANDAs or approve any already received Coughlin, Janis
docket number, found in brackets in the ANDAs for methylphenidate Fantinato, Jessica
heading of this document, into the hydrochloride oral extended-release Gentile, John
‘‘Search’’ box and follow the prompts tablets unless certain BE criteria are
met. FDA will consider any comments Johnson, Jeffrey
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, on the draft guidance on BE Katz, Ruth
Rockville, MD 20852. recommendations for generic Kretschmaier, Michon
You may submit comments on any methylphenidate hydrochloride oral Lewis, Lisa
ethrower on DSK3G9T082PROD with NOTICES
guidance at any time (see 21 CFR extended-release tablets before McDaniel, Eileen
10.115(g)(5)). responding to KVK-Tech’s citizen Novy, Steve
Submit written requests for single petition. (Docket No. FDA–2016–P–
copies of the draft guidance to the Sample, Allen
1247, available at https://
Division of Drug Information, Center for www.regulations.gov). Skeadas, Christos
Drug Evaluation and Research, Food The new draft guidance is being Tobias, Constance
and Drug Administration, 10001 New issued consistent with FDA’s good Weber, Mark
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![Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49035
Dated: October 16, 2017. be used instead of ‘‘Eastern Savings Dated: October 18, 2017.
Charles H. McEnerney III, Time (EST).’’ Sylvia L. Neal,
Director, Executive and Scientific Resources Dated: October 13, 2017. Program Analyst, Office of Federal Advisory
Division. Committee Policy.
Michael D. Weahkee,
[FR Doc. 2017–22863 Filed 10–20–17; 8:45 am] [FR Doc. 2017–22911 Filed 10–20–17; 8:45 am]
Assistant Surgeon General, U.S. Public Health
BILLING CODE 4151–17–P Service, Acting Director, Indian Health BILLING CODE 4140–01–P
Service.
[FR Doc. 2017–22864 Filed 10–20–17; 8:45 am]
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
BILLING CODE 4165–16–P
HUMAN SERVICES HUMAN SERVICES
Indian Health Service
DEPARTMENT OF HEALTH AND National Institutes of Health
Division of Behavioral Health; Youth HUMAN SERVICES
Regional Treatment Center Aftercare National Heart, Lung, and Blood
National Institutes of Health Institute; Notice of Closed Meeting
Pilot Project; Correction of Due Dates
AGENCY: Indian Health Service, HHS. National Institute of Nursing Research; Pursuant to section 10(d) of the
Notice of Closed Meetings Federal Advisory Committee Act, as
ACTION: Notice; correction of due dates.
amended, notice is hereby given of a
Pursuant to section 10(d) of the
SUMMARY: The Indian Health Service meeting of the NHLBI Special Emphasis
Federal Advisory Committee Act, as
published a notice in the Federal Panel.
amended, notice is hereby given of the
Register (FR) on October 11, 2017, for The meeting will be closed to the
following meetings.
the Fiscal Year 2018 Youth Regional
The meetings will be closed to the public in accordance with the
Treatment Center Aftercare Pilot Project,
public in accordance with the provisions set forth in sections
Funding Announcement Number: HHS–
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
2018–IHS–YRTC–0001. Several Key
Dates have been modified. The 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and
Application Due Date is November 12, as amended. The grant applications and the discussions could disclose
2017 and the Earliest Anticipated Start the discussions could disclose confidential trade secrets or commercial
Date is December 1, 2017. confidential trade secrets or commercial property such as patentable material,
property such as patentable material, and personal information concerning
FOR FURTHER INFORMATION CONTACT: Paul
and personal information concerning individuals associated with the grant
Gettys, Grant Systems Coordinator, 5600
individuals associated with the grant applications, the disclosure of which
Fishers Lane, Mail Stop: 09E70,
applications, the disclosure of which would constitute a clearly unwarranted
Rockville, MD 20857, Phone: (301) 443–
would constitute a clearly unwarranted invasion of personal privacy.
2114; or the Division of Grants
invasion of personal privacy.
Management main line (301) 443–5204, Name of Committee: National Heart, Lung,
or Fax: (301) 594–0899. Name of Committee: National Institute of and Blood Institute Special Emphasis Panel;
Nursing Research Special Emphasis Panel; SPIROMICS Genomics and Informatics
Correction Palliative Care Research Cooperative.
Center (U24).
Date: November 3, 2017.
In the FR notice of October 11, 2017 Time: 8:00 a.m. to 1:00 p.m. Date: November 15, 2017.
(FR 2017–21786), the corrections are: Agenda: To review and evaluate grant Time: 10:00 a.m. to 12:00 p.m.
applications. Agenda: To review and evaluate grant
Key Dates
Place: Bethesda Marriott Suites, 6711 applications.
Under the heading Key Dates, the Democracy Boulevard, Bethesda, MD 20817 Place: National Institutes of Health, 6701
notice should include the dates for (Telephone Conference Call). Rockledge Drive, Suite 7182, Bethesda, MD
Review Date, Signed Tribal Resolutions Contact Person: Mario Rinaudo, MD, 20892 (Telephone Conference Call).
Due Date, and Proof of Non-Profit Scientific Review Officer, Office of Review, Contact Person: Susan Wohler Sunnarborg,
Status Due Date should read as: National Inst of Nursing Research, National Ph.D., Scientific Review Officer, Office of
• Review Date: November 20–24, Institutes of Health, 6701 Democracy Blvd. Scientific Review/DERA, National, Heart,
(DEM 1), Suite 710, Bethesda, MD 20892,
2017. Lung, and Blood Institute, 6701 Rockledge
301–594–5973, mrinaudo@mail.nih.gov.
• Signed Tribal Resolutions Due Date: Drive, Room 7182, Bethesda, MD 20892,
Name of Committee: National Institute of susan.sunnarborg@nih.gov.
November 12, 2017. Nursing Research Special Emphasis Panel;
• Proof of Non-Profit Status Due Date: Lasker Clinical Research Scholars Program. (Catalogue of Federal Domestic Assistance
November 12, 2017. Date: November 7, 2017. Program Nos. 93.233, National Center for
The Application Due Date remains as Time: 11:00 a.m. to 1:00 p.m. Sleep Disorders Research; 93.837, Heart and
November 12, 2017. Agenda: To review and evaluate grant Vascular Diseases Research; 93.838, Lung
applications. Diseases Research; 93.839, Blood Diseases
Project Period Place: National Institutes of Health, One and Resources Research, National Institutes
Under Project Period, the sentence Democracy Plaza, 6701 Democracy of Health, HHS)
corrections reflects a start date of Boulevard, Room 703, Bethesda, MD 20892
(Telephone Conference Call). Dated: October 17, 2017.
December 1, 2017:
ethrower on DSK3G9T082PROD with NOTICES
Contact Person: Weiqun Li, MD, Scientific Michelle Trout,
• ‘‘The project period is for three Review Officer, National Institute of Nursing
years and will run consecutively from Program Analyst, Office of Federal Advisory
Research, National Institutes of Health, 6701
December 1, 2017 to October 31, 2020.’’ Committee Policy.
Democracy Blvd., Room 710, Bethesda, MD
20892, (301) 594–5966, wli@mail.nih.gov. [FR Doc. 2017–22908 Filed 10–20–17; 8:45 am]
Submission Dates BILLING CODE 4140–01–P
(Catalogue of Federal Domestic Assistance
Under Submission Dates and time: Program Nos. 93.361, Nursing Research,
‘‘Eastern Daylight Time (EDT)’’ should National Institutes of Health, HHS)
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Document Created: 2017-10-21 02:35:41
Document Modified: 2017-10-21 02:35:41
| 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 | |
| FR Citation | 82 FR 49034 |
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