33938 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 

‘‘Providing Regulatory Submissions in 

Electronic Format—Drug Establishment 

Registration and Drug Listing.’’ The 

document provides guidance to industry 

on the statutory requirement to submit 

electronically drug establishment 

registration and drug listing 

information. The guidance describes the 

types of information to include for 

purposes of drug establishment 

registration and drug listing and how to 

prepare and submit the information in 

an electronic format (Structured Product 

Labeling (SPL) files) that FDA can 

process, review, and archive. The 

burden attributed to the guidance 

includes the preparation of an SOP for 

creating and uploading the SPL file. 

Although most firms will already have 

prepared an SOP for the electronic 

submission of drug establishment 

registration and drug listing 

information, each year additional firms 

will need to create an SOP. As reflected 

in table 2, FDA estimates that 

approximately 1,000 firms will expend 

40 hours to prepare, review, and 

approve an SOP, for a total of 40,000 

hours annually. 

Dated: July 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15298 Filed 7–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2281] 

Innovative Approaches for 

Nonprescription Drug Products; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Innovative Approaches for 

Nonprescription Drug Products.’’ This 

draft guidance describes two innovative 

approaches that may be useful to 

consider for demonstrating safety and 

effectiveness for a nonprescription drug 

product in cases where the drug facts 

labeling (DFL) alone is not sufficient to 

ensure that the drug product can be 

used safely and effectively in a 

nonprescription setting: The 

development of labeling in addition to 

the DFL and the implementation of 

additional conditions so that consumers 

appropriately self-select and use the 

product. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 17, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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–D–2281 for ‘‘Innovative 

Approaches for Nonprescription Drug 

Products; Draft Guidance for Industry; 

Availability.’’ Received comments 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 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Wheeler, Center for Drug 

Evaluation and Research, 10903 New 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33939 

Hampshire Ave., Bldg. 51, Rm. 3330, 

Silver Spring, MD 20993, 301–796– 

0151. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Innovative Approaches for 

Nonprescription Drug Products.’’ FDA 

approves new drugs as prescription or 

nonprescription drug products under 

section 505 of the Food, Drug, and 

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

355). A drug product must be dispensed 

by prescription if it is not safe to use 

except under the supervision of a 

practitioner licensed by law to 

administer the drug (health care 

practitioner) (see section 503(b)(1) of the 

FD&C Act (21 U.S.C. 353(b)(1)). If a drug 

product does not meet the criteria for 

prescription-only dispensing, it may be 

marketed as a nonprescription drug 

product. FDA determines whether the 

information submitted as part of a new 

drug application (NDA) for a 

nonprescription drug product is 

sufficient to ensure that the drug 

product is safe and effective for 

nonprescription use under the 

conditions prescribed, recommended, or 

suggested in its proposed labeling (see 

section 505(d) and 503(b)(1) of the 

FD&C Act. 

Nonprescription drug products must 

comply with applicable labeling 

requirements for over-the-counter (OTC) 

drug products under 21 CFR part 201, 

including, but not limited to, the format 

and content requirements for OTC drug 

product labeling under § 201.66. 

Labeling created to satisfy the 

requirements in § 201.66 is commonly 

referred to as the DFL. The DFL is 

intended to help enable consumers to 

appropriately self-select and use the 

nonprescription drug product safely and 

effectively. 

FDA has received a number of 

inquiries about: (1) Additional labeling, 

beyond the DFL, that FDA can approve 

for nonprescription drug products and 

(2) whether applications may be 

submitted for nonprescription drug 

products with one or more additional 

conditions that consumers must fulfill 

to ensure that the drug product is safe 

and effective for nonprescription use. 

FDA is issuing this draft guidance to 

describe two innovative approaches to 

consider that may be useful for 

demonstrating safety and effectiveness 

for a nonprescription drug product in 

cases where the DFL alone is not 

sufficient to ensure that the drug 

product can be used safely and 

effectively in a nonprescription setting: 

(1) The development of labeling in 

addition to the DFL and (2) the 

implementation of additional conditions 

so that consumers appropriately selfselect and use the product. The 

appropriateness and specific details of 

either of these approaches will depend 

on the circumstances that apply to a 

particular drug product. FDA believes 

the innovative approaches described in 

this draft guidance could lead to the 

approval of a wider range of 

nonprescription drug products. FDA 

currently intends to issue a proposed 

rule that provides more details 

regarding the use of additional 

conditions for nonprescription drug 

products. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Innovative Approaches for 

Nonprescription Drug Products.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

submission of NDAs under 21 CFR 

314.50 to market nonprescription drug 

products has been approved by OMB 

under control number 0910–0001. In 

addition, OTC Drug Facts Labeling 

requirements under § 201.66 have been 

approved under OMB control number 

0910–0340. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: July 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15296 Filed 7–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1324] 

Advisory Committee; Science Board to 

the Food and Drug Administration; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the renewal of the Science 

Board to the Food and Drug 

Administration (Committee) by the 

Commissioner of Food and Drugs 

(Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Science Board to 

the Food and Drug Administration for 

an additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until June 26, 2020. 

DATES: Authority for the Science Board 

to the Food and Drug Administration 

will expire on June 26, 2020, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Rakesh Raghuwanshi, Office of the 

Chief Scientist, Office of the 

Commissioner, Food and Drug 

Administration, White Oak Building 1, 

Rm. 3309, 10903 New Hampshire Ave., 

Silver Spring, MD 20993, 301–796– 

4769, rakesh.raghuwanshi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Science Board to the Food and Drug 

Administration. The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Science Board 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. The 

Science Board shall provide advice to 

the Commissioner and other appropriate 

officials on specific complex scientific 

and technical issues important to FDA 

and its mission, including emerging 

issues within the scientific community. 

Additionally, the Science Board will 

provide advice that supports the Agency 

in keeping pace with technical and 

scientific developments, including in 


amozie on DSK3GDR082PROD with NOTICES1