33934 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 

FEDERAL RETIREMENT THRIFT 

INVESTMENT BOARD 

Sunshine Act; Notice of Meeting July 

24, 2018, Telephonic, 12:00 p.m., 10th 

Floor Board Meeting Room, 77 K Street 

NE, Washington, DC 20002 

Agenda 

FEDERAL RETIREMENT THRIFT INVESTMENT

BOARD MEMBER MEETING STATUS: All 

parts will be open to the public. 

MATTERS TO BE CONSIDERED: 

Open Session 

1. Approval of the Minutes for the June 

25, 2018 Board Member Meeting 

2. Monthly Reports 

(a) Participant Activity 

(b) Legislative Report 

3. Quarterly Reports 

(c) Investment Performance 

(d) Budget Review 

(e) Audit Status 

4. Enterprise Risk Management Update 

5. IT Update 

CONTACT PERSON FOR MORE INFORMATION: 

Kimberly Weaver, Director, Office of 

External Affairs, (202) 942–1640. 

Dated: July 16, 2018. 

Dharmesh Vashee, 

Deputy General Counsel, Federal Retirement 

Thrift Investment Board. 

[FR Doc. 2018–15433 Filed 7–16–18; 4:15 pm] 

BILLING CODE 6760–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB NO.: 0970–0383] 

Submission for OMB Review; 

Comment Request; Evaluation of the 

Transitional Living Program (TLP)— 

Extension 

Description: 

The Family and Youth Services 

Bureau (FYSB) and the Office of 

Planning, Research, Evaluation (OPRE) 

in the Administration for Children and 

Families (ACF) are requesting to 

continue collecting data as part of a 

currently approved information 

collection (OMB No. 0970–0383). The 

purpose is to continue baseline data 

collection at study enrollment and 

follow-up data collection for the 

Evaluation of the Transitional Living 

Program (TLP). The TLP evaluation was 

designed to examine the effects of 

FYSB’s Transitional Living Program on 

runaway and homeless youth, focusing 

on such outcomes as housing and 

homelessness, education or training, 

employment, social connections, socioemotional well-being, and risk 

behaviors. 

Data collection will include three 

primary surveys: (1) A survey 

administered at the time of TLP 

enrollment (baseline), (2) a survey 

administered 6 months after enrollment, 

which will collect information on shortterms outcomes; and (3) a survey 

administered at 12 months, which will 

collect information on longer-term 

outcomes.’’ Participants will be enrolled 

through the TLP study sites. 

Respondents: Runaway and homeless 

youth ages 16 to 22 who agree to 

participate in the study upon 

enrollment into one of the TLP study 

sites. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Young Adult Baseline Survey .............................................. 600 200 1 0.62 124 

Young Adult 6-Month Follow Up Survey ............................. 600 200 1 0.61 122 

Young Adult 12-Month Follow Up Survey ........................... 600 200 1 0.61 122 

Estimated Total Burden Hours ..................................... ........................ ........................ ........................ ........................ 368 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW, Washington, DC 20201, 

Attn: OPRE Reports Clearance Officer. 

All requests should be identified by the 

title of the information collection. Email 

address: OPREinfocollection@

acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget 

Paperwork Reduction Project 

Email: OIRA_SUBMISSION@

OMB.EOP.GOV 

Attn: Desk Officer for the 

Administration for Children and 

Families 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–15307 Filed 7–17–18; 8:45 am] 

BILLING CODE 4184–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0742] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Registration of 

Producers of Drugs and Listing of 

Drugs in Commercial Distribution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each extension of an existing 

collection of information, and to allow 

60 days for public comment in response 

to the notice. This notice solicits 

comments on information collection for 

drug establishment registration and 

product listing. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 17, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 17, 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33935 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 17, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2011–N–0742 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution.’’ 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 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution—21 CFR Part 207 

OMB Control Number 0910–0045— 

Extension 

This information collection supports 

FDA’s drug establishment registration 

and listing regulations and associated 

guidance intended to assist respondents 

in this regard. Requirements for drug 

establishment registration and drug 

listing are set forth in section 510 of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360), and 

section 351 of the Public Health Service 

Act (42 U.S.C. 262). Section 224 of the 

Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85) amended section 510(p) of the FD&C 

Act to require electronic drug 

establishment registration and drug 

listing. Regulations implementing these 

provisions are established under 21 CFR 

part 207. Except as provided in § 207.65, 

all information submitted must be 

transmitted to FDA in electronic format 

by using our electronic drug registration 

and listing system, in a form that we can 

process, review, and archive. 

Establishment registration information 

helps FDA identify who is 

manufacturing, repacking, relabeling, 


amozie on DSK3GDR082PROD with NOTICES1
33936 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 

and salvaging drugs and where those 

operations are performed. Drug listing 

information gives FDA a current 

inventory of drugs manufactured, 

repacked, relabeled, or salvaged for 

commercial distribution. Both types of 

information facilitate implementation 

and enforcement of the FD&C Act and 

are used for many important public 

health purposes. 

Registration Under Part 207 

Unless otherwise exempt under 

section 510(g) of the FD&C Act or 

§ 207.13, all manufacturers, repackers, 

relabelers, and salvagers must register 

each domestic establishment that 

manufactures, repacks, relabels, or 

salvages a drug, or an animal feed 

bearing or containing a new animal 

drug, and each foreign establishment 

that manufactures, repacks, relabels, or 

salvages a drug, or an animal feed 

bearing or containing a new animal 

drug, that is imported or offered for 

import into the United States. When 

operations are conducted at more than 

one establishment and common 

ownership and control among all the 

establishments exists, the parent, 

subsidiary, or affiliate company may 

submit registration information for all 

establishments. 

Private label distributors who do not 

also manufacture, repack, relabel, or 

salvage drugs are not required to register 

under part 207. FDA will accept 

registration or listing information 

submitted by a private label distributor 

only if it is acting as an authorized agent 

for and submitting information that 

pertains to an establishment that 

manufactures, repacks, relabels, or 

salvages drugs. 

Under § 207.21, domestic 

manufacturers, domestic repackers, 

domestic relabelers, and domestic drug 

product salvagers must complete initial 

registration of each establishment no 

later than 5 calendar days after 

beginning to manufacture, repack, 

relabel, or salvage a drug. In addition, 

foreign manufacturers, foreign 

repackers, foreign relabelers, and foreign 

drug product salvagers must register 

each establishment before the drug is 

imported or offered for import into the 

United States. 

The information that must be 

provided to FDA for registration is 

described in § 207.25 and includes the 

following: (1) Name of the owner or 

operator of each establishment; if a 

partnership, the name of each partner; if 

a corporation, the name of each 

corporate officer and director, and the 

place of incorporation; (2) each 

establishment’s name, physical address, 

and telephone number(s); (3) all name(s) 

of the establishment, including names 

under which the establishment 

conducts business or names by which 

the establishment is known; (4) 

registration number of each 

establishment, if previously assigned by 

FDA; (5) a Unique Facility Identifier in 

accordance with the system specified 

under section 510 of the FD&C Act; (6) 

all types of operations performed at 

each establishment; (7) name, mailing 

address, telephone number, and email 

address of the official contact for the 

establishment, as provided in 

§ 207.69(a); and (8) additionally, with 

respect to foreign establishments subject 

to registration, the name, mailing 

address, telephone number, and email 

address must be provided for: (a) The 

U.S. agent, as provided in § 207.69(b); 

(b) each importer in the United States of 

drugs manufactured, repacked, 

relabeled, or salvaged at the 

establishment that is known to the 

establishment; and (c) each person who 

imports or offers for import such drug 

to the United States. 

Registrants must update their 

registration information as prescribed 

under § 207.29. 

National Drug Code (NDC) 

The NDC for a drug is a numeric code. 

Each finished drug product or 

unfinished drug subject to the listing 

requirements of part 207 must have a 

unique NDC to identify its labeler, 

product, and package size and type. The 

format of an NDC is described under 

§ 207.33. 

Under § 207.35, registrants must 

notify us of a change in any of the drug 

characteristics (except certain 

identifying information) for an NDC in 

§ 207.33, and assign a new product code 

and package code for that drug. 

Listing Under Part 207 

Under § 207.41, registrants must list 

each drug that it manufactures, repacks, 

relabels, or salvages for commercial 

distribution. Each domestic registrant 

must list each such drug regardless of 

whether the drug enters interstate 

commerce. When operations are 

conducted at more than one 

establishment, and common ownership 

and control exists among all the 

establishments, the parent, subsidiary, 

or affiliate company may submit listing 

information for any drug manufactured, 

repacked, relabeled, or salvaged at any 

such establishment. A drug 

manufactured, repacked, or relabeled for 

private label distribution must be listed 

in accordance with the requirements. 

Registrants must provide listing 

information for each drug in accordance 

with the listing requirements described 

in §§ 207.49, 207.53, and 207.54 that 

correspond to the activity or activities 

they engage in for that drug. For both 

animal and human drugs, each 

registrant must list each drug it 

manufactures, repacks, or relabels for 

commercial distribution under the trade 

name or label of a private label 

distributor using an NDC that includes 

such private label distributor’s labeler 

code. 

Additionally, in the case of human 

drugs, each registrant must list each 

human drug it manufactures, repacks, or 

relabels using an NDC that includes the 

registrant’s own labeler code, regardless 

of whether the drug is commercially 

distributed under the registrant’s own 

label or trade name or under the label 

or trade name of a private label 

distributor. 

Under § 207.45, for each drug being 

manufactured, repacked, relabeled, or 

salvaged for commercial distribution at 

an establishment at the time of initial 

registration, drug listing information 

must be submitted no later than 3 

calendar days after the initial 

registration of the establishment. 

Each registrant must provide the 

listing information described under 

§ 207.49 for each drug it manufactures 

for commercial distribution. Each 

registrant must also provide the listing 

information for each drug it repacks or 

relabels under § 207.53. A registrant 

who also relabels or repacks a drug that 

it salvages must list the drug it relabels 

or repacks in accordance with § 207.53. 

Registrants who perform only salvaging 

with respect to a drug must provide the 

listing information for that drug as 

required under § 207.54. Additional 

information may be requested for a 

listed drug as described in § 207.55. 

Under § 207.57, registrants must 

update drug listing information 

submitted previously (either when the 

change is made or, at a minimum, each 

June and December). Registrants must 

also notify FDA if any listed drug has 

been discontinued from marketing or if 

any discontinued drug has been 

reintroduced and provide listing 

information for any drug not yet listed 

(at the time of annual establishment 

registration if not sooner). 

We estimate the burden of the 

information collection as follows: 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33937 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Hours per 

response Total hours 

Initial establishment registration; §§ 207.17, 207.21, 

207.25.

1,480 2 2,960 1 ........................... 2,960 

Annual review and update of registration information 

(including expedited updates); § 207.29.

10,000 1 10,000 .5 (30 minutes) ..... 5,000 

Initial listing (including NDC); §§ 207.33, 207.41, 

207.45, 207.49, 207.53, 207.54, 207.55.

1,713 7.28 12,470 1.5 ........................ 18,705 

June and December review and update (or certification) of listing; §§ 207.35, 207.57.5,300 20 106,000 .75 (45 minutes) ... 79,500 

Waiver requests; § 207.65 ............................................. 1 1 1 .5 (30 minutes) ..... 1 

Public disclosure exemption requests; § 207.81(c) ....... 100 1 100 1 ........................... 100 

Total ....................................................................... ........................ ........................ ........................ .............................. 106,266 

1There are no capital or operating and maintenance costs associated with the information collection. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Standard operating procedure (SOP) for 

creating and uploading the SPL file 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual records 

Average 

burden per 

recordkeeping 

Total hours 

Preparation of SOP ............................... 1,000 1 1,000 40 40,000 

1 There are no capital or operating and maintenance costs associated with the information collection. 

Based on FDA data, we estimate that 

1,480 respondents will submit 2,960 

new establishment registrations 

annually. Based on the number of 

registered establishments in our 

database, we estimate 10,000 registrants 

will provide 10,000 annual reviews and 

updates of registration information 

(including expedited updates) or 

reviews and certifications that no 

changes have occurred. The estimates 

include the registration of 

establishments for both domestic and 

foreign manufacturers, repackers, 

relabelers, and drug product salvagers, 

and registration information submitted 

by anyone acting as an authorized agent 

for an establishment that manufactures, 

repacks, relabels, or salvages drugs. The 

estimates include an additional 80 

positron emission tomography (PET) 

drug producers who are not exempt 

from registration and approximately 30 

manufacturers of plasma derivatives. 

We estimate that it will take 1 hour 

for registrants to submit initial 

registration information electronically 

for each new establishment. We also 

estimate that it will take approximately 

30 minutes for each annual review and 

update of registration information 

(including any expedited updates) or 

each review and certification that no 

changes have occurred. The burden 

hour estimates above are based on our 

familiarity with the amount of time it 

takes registrants to input registration 

information electronically since June 

2009. The estimates are an average of 

the time it would take to register a 

domestic or foreign establishment and 

an average of the time it would take to 

review registration information and 

update several registration items in the 

database or review registration 

information and only certify that no 

changes have occurred. 

Based on the number of drugs listed 

annually since June 2009, we estimate 

that approximately 1,713 registrants will 

report 12,469 new listings annually 

(including the information submitted to 

obtain a labeler code and to reserve an 

NDC for future use). 

Based on the number of drugs in our 

listing database and the current number 

of changes to listing information 

submitted, we estimate 5,300 registrants 

will each report 20 reviews and updates 

(including the information submitted to 

revise an NDC) for a total of 106,000 

annually. 

The estimates for the number of drug 

listings include both domestic and 

foreign listings, listings submitted by 

registrants for products sold under their 

own names as well as products intended 

for private label distribution, and 

information submitted related to an 

NDC and to obtain a labeler code. The 

estimate for the number of drugs subject 

to the listing requirements includes PET 

drugs and approximately 30 plasma 

derivatives. The estimates for the 

number of June and December reviews 

and updates of listing information 

include the number of changes to drug 

characteristics pertaining to the drug 

product code to obtain a new NDC and 

the reports of the withdrawal of an 

approved drug from sale under 21 CFR 

314.81(b)(3)(iii). 

Based on our familiarity with the time 

required to input listing information 

electronically since June 2009, we 

estimate that it will take registrants 1 

hour and 30 minutes to submit 

information electronically for each drug 

they list for the first time (for both 

foreign and domestic registrant listings). 

These estimates are an average of the 

time it will take manufacturers, 

repackers, relabelers, and drug product 

salvagers, with drug product salvagers 

taking considerably less time than 

manufacturers. The estimates include 

the time for submitting the content of 

labeling and other labeling in electronic 

format. (For drugs subject to an 

approved marketing application, the 

electronic submission of the content of 

labeling under § 314.50(l)(1)(i) is 

approved under OMB control number 

0910–0001). We also estimate that it 

will take 45 minutes for each June and 

December review and update. These 

estimates represent the average amount 

of time to review and update listing 

information or to review and certify that 

no changes have occurred. The 

estimates include the time for 

submitting any labeling for each drug, 

changes to the drug’s characteristics 

submitted for a new NDC, and reports 

of the withdrawal of an approved drug 

from sale under § 314.81(b)(3)(iii). 

In 2009, to help respondents 

transition to the current electronic 

reporting requirements, FDA issued the 

guidance for industry entitled 


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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 


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