Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices 44057 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6248, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holder of an approved application to 

market a new drug for human use is 

required to submit annual reports to 

FDA concerning its approved 

application in accordance with § 314.81 

(21 CFR 314.81). DHL Laboratories Inc. 

has failed to submit the required annual 

reports and has not responded to the 

Agency’s request for submission of the 

reports. 

Therefore, notice is given to DHL 

Laboratories Inc. and to all other 

interested persons that the Director of 

CDER proposes to issue an order, under 

section 505(e) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(e)), withdrawing approval of NDA 

019971, Dextrose 5% in Plastic 

Container, 5 g/100 mL, and all 

amendments and supplements to it on 

the grounds that DHL Laboratories Inc. 

has failed to submit reports required 

under § 314.81. 

In accordance with section 505 of the 

FD&C Act and part 314 (21 CFR part 

314), DHL Laboratories Inc. is hereby 

provided an opportunity for a hearing to 

show why approval of NDA 019971 

should not be withdrawn and an 

opportunity to raise, for administrative 

determination, all issues relating to the 

legal status of the drug product covered 

by this application. 

An applicant who decides to seek a 

hearing must file the following: (1) A 

written notice of participation and 

request for a hearing (see DATES and 

ADDRESSES) and (2) the data, 

information, and analyses relied on to 

demonstrate that there is a genuine and 

substantial issue of fact that requires a 

hearing (see DATES and ADDRESSES). Any 

other interested person may also submit 

comments on this notice. The 

procedures and requirements governing 

this notice of opportunity for a hearing, 

notice of participation and request for a 

hearing, the information and analyses to 

justify a hearing, other comments, and 

a grant or denial of a hearing are 

contained in § 314.200 and in 21 CFR 

part 12. 

The failure of an applicant to file a 

timely written notice of participation 

and request for a hearing, as required by 

§ 314.200, constitutes an election by that 

applicant not to avail itself of the 

opportunity for a hearing concerning 

CDER’s proposal to withdraw approval 

of the application and constitutes a 

waiver of any contentions concerning 

the legal status of the drug product. FDA 

will then withdraw approval of the 

application, and the drug product may 

not thereafter be lawfully introduced or 

delivered for introduction into interstate 

commerce. Any new drug product 

introduced or delivered for introduction 

into interstate commerce without an 

approved application is subject to 

regulatory action at any time. 

A request for a hearing may not rest 

upon mere allegations or denials, but 

must present specific facts showing that 

there is a genuine and substantial issue 

of fact that requires a hearing. If a 

request for a hearing is not complete or 

is not supported, the Commissioner of 

Food and Drugs will enter summary 

judgment against the person who 

requests the hearing, making findings 

and conclusions, and denying a hearing. 

All submissions under this notice of 

opportunity for a hearing must be filed 

in four copies. Except for data and 

information prohibited from public 

disclosure under 21 U.S.C. 331(j) or 18 

U.S.C. 1905, the submissions may be 

seen at the Dockets Management Staff 

(see ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday, and will 

be posted to the docket at https://

www.regulations.gov. 

This notice is issued under section 

505(e) of the FD&C Act and under 

authority delegated to the Director of 

CDER by the Commissioner of Food and 

Drugs. 

Dated: August 24, 2018. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2018–18749 Filed 8–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

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 DoussardRoosevelt, 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, doussarj@csr.nih.gov. 

(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 


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