83 FR 44057 - Center for Scientific Review; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 168 (August 29, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 168 (August 29, 2018)
| Page Range | 44057-44057 | |
| FR Document | 2018-18652 |
[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)] [Notices] [Page 44057] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18652] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 PAR Panel: Mechanisms and Consequences of Sleep Disparities. Date: September 25-26, 2018. Time: 7:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Jane A Doussard-Roosevelt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435-4445, [email protected]. (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: August 22, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018-18652 Filed 8-28-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices 44057
Staff. If you do not wish your name and An applicant who decides to seek a Dated: August 24, 2018.
contact information to be made publicly hearing must file the following: (1) A Janet Woodcock,
available, you can provide this written notice of participation and Director, Center for Drug Evaluation and
information on the cover sheet and not request for a hearing (see DATES and Research.
in the body of your comments and you ADDRESSES) and (2) the data, [FR Doc. 2018–18749 Filed 8–28–18; 8:45 am]
must identify this information as information, and analyses relied on to BILLING CODE 4164–01–P
‘‘confidential.’’ Any information marked demonstrate that there is a genuine and
as ‘‘confidential’’ will not be disclosed substantial issue of fact that requires a
except in accordance with 21 CFR 10.20 hearing (see DATES and ADDRESSES). Any DEPARTMENT OF HEALTH AND
and other applicable disclosure law. For other interested person may also submit HUMAN SERVICES
more information about FDA’s posting comments on this notice. The
of comments to public dockets, see 80 procedures and requirements governing National Institutes of Health
FR 56469, September 18, 2015, or access
this notice of opportunity for a hearing,
the information at: https://www.gpo.gov/ Center for Scientific Review; Notice of
notice of participation and request for a
fdsys/pkg/FR-2015-09-18/pdf/2015- Closed Meeting
hearing, the information and analyses to
23389.pdf.
Docket: For access to the docket to justify a hearing, other comments, and
a grant or denial of a hearing are Pursuant to section 10(d) of the
read background documents or the Federal Advisory Committee Act, as
electronic and written/paper comments contained in § 314.200 and in 21 CFR
part 12. amended, notice is hereby given of the
received, go to https:// following meeting.
www.regulations.gov and insert the The failure of an applicant to file a
docket number, found in brackets in the timely written notice of participation The meeting will be closed to the
heading of this document, into the and request for a hearing, as required by public in accordance with the
‘‘Search’’ box and follow the prompts § 314.200, constitutes an election by that provisions set forth in sections
and/or go to the Dockets Management applicant not to avail itself of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Staff, 5630 Fishers Lane, Rm. 1061, opportunity for a hearing concerning as amended. The grant applications and
Rockville, MD 20852. CDER’s proposal to withdraw approval the discussions could disclose
FOR FURTHER INFORMATION CONTACT: of the application and constitutes a confidential trade secrets or commercial
Florine P. Purdie, Center for Drug waiver of any contentions concerning property such as patentable material,
Evaluation and Research, Food and the legal status of the drug product. FDA and personal information concerning
Drug Administration, 10903 New will then withdraw approval of the individuals associated with the grant
Hampshire Ave., Bldg. 51, Rm. 6248, application, and the drug product may applications, the disclosure of which
Silver Spring, MD 20993–0002, 301– not thereafter be lawfully introduced or would constitute a clearly unwarranted
796–3601. delivered for introduction into interstate invasion of personal privacy.
SUPPLEMENTARY INFORMATION: The commerce. Any new drug product Name of Committee: Center for Scientific
holder of an approved application to introduced or delivered for introduction Review Special Emphasis Panel PAR Panel:
market a new drug for human use is into interstate commerce without an Mechanisms and Consequences of Sleep
required to submit annual reports to approved application is subject to Disparities.
FDA concerning its approved regulatory action at any time. Date: September 25–26, 2018.
application in accordance with § 314.81 Time: 7:00 p.m. to 4:00 p.m.
(21 CFR 314.81). DHL Laboratories Inc. A request for a hearing may not rest
Agenda: To review and evaluate grant
has failed to submit the required annual upon mere allegations or denials, but applications.
reports and has not responded to the must present specific facts showing that Place: National Institutes of Health, 6701
Agency’s request for submission of the there is a genuine and substantial issue Rockledge Drive, Bethesda, MD 20892,
reports. of fact that requires a hearing. If a (Virtual Meeting).
Therefore, notice is given to DHL request for a hearing is not complete or Contact Person: Jane A Doussard-
Laboratories Inc. and to all other is not supported, the Commissioner of Roosevelt, Ph.D., Scientific Review Officer,
interested persons that the Director of Food and Drugs will enter summary Center for Scientific Review, National
CDER proposes to issue an order, under judgment against the person who Institutes of Health, 6701 Rockledge Drive,
section 505(e) of the Federal Food, Drug, requests the hearing, making findings Room 3184, MSC 7848, Bethesda, MD 20892,
and Cosmetic Act (FD&C Act) (21 U.S.C. and conclusions, and denying a hearing. (301) 435–4445, doussarj@csr.nih.gov.
355(e)), withdrawing approval of NDA All submissions under this notice of (Catalogue of Federal Domestic Assistance
019971, Dextrose 5% in Plastic opportunity for a hearing must be filed Program Nos. 93.306, Comparative Medicine;
Container, 5 g/100 mL, and all in four copies. Except for data and 93.333, Clinical Research, 93.306, 93.333,
amendments and supplements to it on information prohibited from public 93.337, 93.393–93.396, 93.837–93.844,
the grounds that DHL Laboratories Inc. disclosure under 21 U.S.C. 331(j) or 18 93.846–93.878, 93.892, 93.893, National
has failed to submit reports required U.S.C. 1905, the submissions may be Institutes of Health, HHS)
under § 314.81. seen at the Dockets Management Staff Dated: August 22, 2018.
In accordance with section 505 of the
(see ADDRESSES) between 9 a.m. and 4 Natasha M. Copeland,
FD&C Act and part 314 (21 CFR part
p.m., Monday through Friday, and will Program Analyst, Office of Federal Advisory
314), DHL Laboratories Inc. is hereby
sradovich on DSK3GMQ082PROD with NOTICES
be posted to the docket at https:// Committee Policy.
provided an opportunity for a hearing to
show why approval of NDA 019971 www.regulations.gov. [FR Doc. 2018–18652 Filed 8–28–18; 8:45 am]
should not be withdrawn and an This notice is issued under section BILLING CODE 4140–01–P
opportunity to raise, for administrative 505(e) of the FD&C Act and under
determination, all issues relating to the authority delegated to the Director of
legal status of the drug product covered CDER by the Commissioner of Food and
by this application. Drugs.
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Document Created: 2018-08-29 00:12:43
Document Modified: 2018-08-29 00:12:43
| 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 | September 25-26, 2018. | |
| FR Citation | 83 FR 44057 |
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