44056 Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3208] 

DHL Laboratories Inc.; Proposal To 

Withdraw Approval of a New Drug 

Application for Dextrose 5% Injection 

in Plastic Container; Opportunity for a 

Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is proposing to withdraw 

approval of a new drug application 

(NDA) for Dextrose 5% Injection in 

Plastic Container, 5 grams (g)/100 

milliliters (mL), held by DHL 

Laboratories Inc., 155 Medical Science 

Dr., Union, SC 23979, and is 

announcing an opportunity for the 

holder of the NDA to request a hearing 

on this proposal. The basis for the 

proposal is that the holder of the NDA 

has repeatedly failed to file required 

annual reports for the NDA. 

DATES: DHL Laboratories Inc. may 

submit a request for a hearing by 

September 28, 2018. Submit all data, 

information, and analyses upon which 

the request for a hearing relies by 

October 29, 2018. Submit electronic or 

written comments by October 29, 2018. 

ADDRESSES: The request for a hearing 

may be submitted by DHL Laboratories 

Inc. by either of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments to 

submit your request for a hearing. 

Comments submitted electronically to 

https://www.regulations.gov, including 

any attachments to the request for a 

hearing, will be posted to the docket 

unchanged. 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• Because your request for a hearing 

will be made public, you are solely 

responsible for ensuring that your 

request does not include any 

confidential information that you or a 

third part may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. The request 

for a hearing must include the Docket 

No. FDA–2018–N–3208 for ‘‘DHL 

Laboratories Inc.; Proposal to Withdraw 

Approval of a New Drug Application for 

Dextrose 5% Injection in Plastic 

Container; Opportunity for a Hearing.’’ 

The request for a hearing will be placed 

in the docket and publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

DHL Laboratories Inc. may submit all 

data and analyses upon which the 

request for a hearing relies in the same 

manner as the request for a hearing 

except as follows: 

• Confidential Submissions—To 

submit any data analyses with 

confidential information that you do not 

wish to be made publicly available, 

submit your data and analyses only as 

a written/paper submission. You should 

submit two copies total of all data and 

analyses. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of any decisions on 

this matter. The second copy, which 

will have the claimed confidential 

information redacted/blacked out, will 

be available for public viewing and 

posted on https://www.regulations.gov 

or available at the Dockets Management 

Staff between 9 a.m. and 4 p.m., 

Monday through Friday. Submit both 

copies to the Dockets Management Staff. 

Any information marked as 

‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. 

Comments Submitted by Other 

Interested Parties: For all comments 

submitted by other interested parties, 

submit comments as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3208 for ‘‘DHL Laboratories 

Inc.; Proposal to Withdraw Approval of 

a New Drug Application for Dextrose 

5% Injection in Plastic Container; 

Opportunity for a Hearing.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 


sradovich on DSK3GMQ082PROD with NOTICES
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 


sradovich on DSK3GMQ082PROD with NOTICES