88398 Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, LYBALVI 

(olanzapine and samidorphan), which is 

indicated for the treatment of: 

• Schizophrenia in adults 

• Bipolar I disorder in adults 

Æ Acute treatment of manic or mixed 

episodes as monotherapy and as 

adjunct to lithium or valproate 

Æ Maintenance monotherapy treatment 

Subsequent to this approval, the 

USPTO received patent term restoration 

applications for LYBALVI (U.S. Patent 

Nos. 7,262,298; 9,119,848; 9,126,977; 

10,300,054; and 10,716,785) from 

Alkermes Inc. and the USPTO requested 

FDA’s assistance in determining the 

patents’ eligibility for patent term 

restoration. In a letter dated September 

28, 2022, FDA advised the USPTO that 

this human drug product had undergone 

a regulatory review period and that the 

approval of LYBALVI represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

USPTO requested that FDA determine 

the product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

LYBALVI is 4,564 days. Of this time, 

4,003 days occurred during the testing 

phase of the regulatory review period, 

while 561 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

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

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

355(i)) became effective: November 30, 

2008. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on November 30, 2008. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: November 15, 2019. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

LYBALVI (NDA 213378) was initially 

submitted on November 15, 2019. 

3. The date the application was 

approved: May 28, 2021. FDA has 

verified the applicant’s claim that NDA 

213378 was approved on May 28, 2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 311 days, 646 days, 

1,325 days, 1,328 days, or 5 years of 

patent term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28094 Filed 12–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4201] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Examination of 

Implied Claims in Direct-to-Consumer 

Prescription Drug Promotion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a proposed study 

entitled ‘‘Examination of Implied 

Claims in Direct-to-Consumer 

Prescription Drug Promotion.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 20, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 20, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88399 

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– 

2023–N–4201 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Examination of Implied Claims in 

Direct-to-Consumer Prescription Drug 

Promotion.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–3794, PRAStaff@

fda.hhs.gov. The draft survey 

instrument is available upon request 

from DTCresearch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), 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 

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. 

Examination of Implied Claims in 

Direct-to-Consumer Prescription Drug 

Promotion 

OMB Control Number 0910–NEW 

I. Background 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA-regulated products 

in carrying out the provisions of the 

FD&C Act. 

The mission of the Office of 

Prescription Drug Promotion (OPDP) is 

to protect the public health by helping 

to ensure that prescription drug 

promotion is truthful, balanced, and 

accurately communicated, so that 

patients and healthcare providers can 

make informed decisions about 

treatment options. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission, 

focusing in particular on three main 

topic areas: advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and the 

characteristics of the disease and 

product impact the communication and 

understanding of prescription drug risks 

and benefits. Focusing on target 

populations allows us to evaluate how 

understanding of prescription drug risks 

and benefits may vary as a function of 

audience. Our focus on research quality 

aims at maximizing the quality of our 

research data through analytical 

methodology development and 

investigation of sampling and response 

issues. This study will inform the first 

topic area, advertising features. 

Because we recognize that the 

strength of data and the confidence in 

the robust nature of the findings are 

improved through the results of 

multiple converging studies, we 

continue to develop evidence to inform 

our thinking. We evaluate the results 

from our studies within the broader 

context of research and findings from 

other sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

homepage at https://www.fda.gov/ 

about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research, which 

includes links to the latest Federal 

Register notices and peer-reviewed 

publications produced by our office. 

Direct-to-consumer (DTC) 

prescription drug promotion may 

include truthful and non-misleading 

claims about the product. A particular 

claim may be direct (explicit) or indirect 

(implied or implicit). Some prior 


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88400 Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 

research has shown that implied claims 

are misremembered as explicit claims 

(Ref. 1). Other research has shown that 

claims can result in a misleading 

impression of the product through 

implication, rather than literal 

interpretation (Ref. 2). Understanding 

how consumers who self-report having 

been diagnosed with a target condition 

interpret implied claims in DTC 

prescription drug promotion—and how 

their perceptions differ from those of 

consumers who have not been 

diagnosed with the target condition— 

will provide valuable insight into the 

relevance and impact of various product 

attributes and promotional claims on 

treatment decisions. 

The current project will test the 

impact of several implied claims in DTC 

prescription drug advertising on 

consumer perceptions. The project has 

two phases: experimental and conjoint 

analysis. In the experimental phase, 

participants will view one version of a 

DTC television ad containing both 

explicit and one of four implicit product 

claims of interest or a control ad 

containing only explicit claims, and be 

asked their impressions of the product’s 

risks, benefits, and other attributes. In 

the conjoint analysis phase, we will 

conduct a best-worst scaling (BWS) 

experiment to elicit the relative 

importance of various characteristics of 

immunotherapies indicated to treat 

patients with advanced melanoma, 

including several implied claims. For 

this study, we will use an object case 

design, which does not require us to 

manipulate different levels of the 

characteristics included in the design. 

Participants will be shown a series of 

choice tasks that are each made up of 

different subsets of an experiment-wide 

list of characteristics. Each participant 

will complete several tasks, and will be 

asked to first select which one they 

would care about the most if they were 

considering an immunotherapy, 

followed by the characteristic they 

would care about the least. 

We are proposing to include 13 

characteristics in our BWS experiment. 

Each task will include only four of those 

characteristics, the combination of 

which will be drawn from a balanced 

incomplete block design (BIBD; see Ref. 

3). A BIBD ensures that (1) each task 

contains the same number of 

characteristics; (2) each characteristic 

occurs the same number of times across 

tasks; and (3) each pair of characteristics 

is shown to participants the same 

number of times over the entire 

experiment. These three properties are 

desirable for meeting estimation 

assumptions (e.g., balance and 

orthogonality). An additional (and 

unique) favorable property of including 

13 characteristics in the experiment is 

that BIBDs exist that yield 13 tasks with 

4 characteristics per task. Thirteen is a 

manageable number of tasks for a single 

participant to complete, and as a result, 

the full experimental design will be 

replicated by each participant. 

We estimate that participation in the 

study will take approximately 20 

minutes. Adult voluntary participants 

aged 18 years or older will be recruited 

by email through an internet panel, and 

participant eligibility will be 

determined with a screener at the 

beginning of the online survey. We will 

exclude individuals who work in 

healthcare settings, employees of the 

Department of Health and Human 

Services, or individuals who work in 

the marketing, advertising, or 

pharmaceutical industries. Half the 

sample will consist of individuals who 

self-identify as cancer survivors, 

excluding survivors of certain 

nonmelanoma skin cancers. 

The target sample size for the 

experimental phase is 1,030 adults and 

the target sample size for the conjoint 

analysis phase is 800 adults. Prior to 

conducting the main study for both the 

experimental phase and conjoint 

analysis phase, we will conduct at least 

one wave of pretests for each study 

phase: one before the experimental 

phase and one before the conjoint 

analysis phase. If the first pretest wave 

reveals that changes to the measurement 

instruments, stimuli, or procedures are 

required, a second pretest wave (for 

either the experimental phase, conjoint 

phase, or both) will be conducted with 

revised materials. The target sample size 

for each wave of pretests is 120 adults, 

split evenly between the experimental 

and conjoint analysis phases. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 2 Total hours 

Experimental phase Pretest 1 Screener 3 ....................... 132 1 132 0.08 (5 minutes) 11 

Experimental Phase Pretest 1 ......................................... 66 1 66 0.33 (20 minutes) 22 

Conjoint Analysis Phase Pretest 1 Screener 3 ................ 132 1 132 0.08 (5 minutes) 11 

Conjoint Analysis Phase Pretest 1 .................................. 66 1 66 0.33 (20 minutes) 22 

Experimental Phase Pretest 2 Screener 3 4 .................... 132 1 132 0.08 (5 minutes) 11 

Experimental Phase Pretest 2 4 ...................................... 66 1 66 0.33 (20 minutes) 22 

Conjoint Analysis Phase Pretest 2 Screener 3 4 .............. 132 1 132 0.08 (5 minutes) 11 

Conjoint Analysis Phase Pretest 2 4 ................................ 66 1 66 0.33 (20 minutes) 22 

Experimental Phase Screener 3 ...................................... 2,266 1 2,266 0.08 (5 minutes) 181 

Experimental Phase Main Study ..................................... 1,133 1 1,133 0.33 (20 minutes) 374 

Conjoint Analysis Phase Screener 3 ................................ 1,760 1 1,760 0.08 (5 minutes) 141 

Conjoint Analysis Phase Main Study .............................. 880 1 880 0.33 (20 minutes) 290 

Total .......................................................................... ........................ ........................ 6,831 ............................ 1,118 

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

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format. 

3 Number of screener respondents assumes a 50 percent eligibility rate with targeted recruitment. 

4Pretest 2 will be conducted only if changes to study materials for the respective study phase are made in response to the findings of Pretest 

1 for that phase. 

As with most online and mail 

surveys, it is always possible that some 

participants are in the process of 

completing the survey when the target 

number is reached and that those 

surveys will be completed and received 

before the survey is closed out. To 

account for this, we have estimated 

approximately 10 percent overage for 


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Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88401 

samples in the pretest and main study 

of the experimental phase and conjoint 

analysis phase. 

II. References 

The following references are on 

display with the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

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

through Friday; these are not available 

electronically at https://

www.regulations.gov as these references 

are copyright protected. Some may be 

available at the website address, if 

listed. FDA has verified the website 

addresses, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

1. Harris, R.J., M.L. Trusty, J.I. Bechtold, et 

al. ‘‘Memory for Implied Versus Directly 

Stated Advertising Claims,’’ Psychology 

& Marketing, vol. 6, issue 2, pp. 87–96, 

1989, https://doi.org/10.1002/ 

mar.4220060202. 

2. Burke, R.R., W.S. DeSarbo, R.L. Oliver, et 

al. ‘‘Deception By Implication: An 

Experimental Investigation,’’ Journal of 

Consumer Research, vol. 14, issue 4, pp. 

483–494, 1988, https://doi.org/10.1086/ 

209130. 

3. Louviere, J.J., T.N. Flynn, and A.A.J. 

Marley, Best-Worst Scaling: Theory, 

Methods, and Applications. Cambridge: 

Cambridge University Press, 2015. 

Dated: December 15, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28093 Filed 12–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1136] 

Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2 for 

Emergency Use Authorization; 

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 final 

guidance for industry entitled 

‘‘Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2 for 

Emergency Use Authorization.’’ This 

guidance provides recommendations to 

sponsors on the development of 

monoclonal antibody products targeting 

SARS–CoV–2 intended for the 

prevention or treatment of COVID–19, 

including addressing the impact of 

emerging variants. The 

recommendations focus on the data and 

information that may be used to support 

a request for emergency use 

authorization (EUA) under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). This guidance supersedes the 

guidance entitled ‘‘Development of 

Monoclonal Antibody Products 

Targeting SARS–CoV–2, Including 

Addressing the Impact of Emerging 

Variants, During the COVID–19 Public 

Health Emergency’’ issued on February 

22, 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 21, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2020–D–1136 for ‘‘Development of 

Monoclonal Antibody Products 

Targeting SARS–CoV–2 for Emergency 

Use Authorization.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 


khammond on DSKJM1Z7X2PROD with NOTICES