Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 81925 

electronically by 11:59 p.m. (EST) or 

postmarked by February 16, 2021. 

ADDRESSES: Submit electronic 

comments on the information collection 

request to: Peter Nye at 

OILPPRAComments@acl.hhs.gov. 

Submit written comments on the 

collection of information to 

Administration for Community Living, 

Washington, DC 20201, Attention: Peter 

Nye. 

FOR FURTHER INFORMATION CONTACT: 

Peter Nye, Administration for 

Community Living, Washington, DC 

20201, (202) 795–7606, or peter.nye@

acl.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’’ 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, ACL is 

publishing a notice of the proposed 

collection of information set forth in 

this document. 

With respect to the following 

collection of information, ACL invites 

comments on our burden estimates or 

any other aspect of this collection of 

information, including: 

(1) Whether the proposed collection 

of information is necessary for the 

proper performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(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. 

The Independent Living Services 

(ILS) program provides financial 

assistance, through formula grants, to 

states, the District of Columbia, Puerto 

Rico, American Samoa, the 

Commonwealth of the Northern Mariana 

Islands, Guam, and the US Virgin 

Islands for expanding, and improving 

the provision of, independent living (IL) 

services. The Designated State Entity 

(DSE) is the agency that, on behalf of the 

state, receives, accounts for, and 

disburses funds received under Part B of 

the Rehabilitation Act of 1973, as 

amended (the Act). Funds are also made 

available for the provision of training 

and technical assistance to Statewide 

Independent Living Councils (SILCs). 

The Act permits an annual program 

performance report (PPR). This request 

is for the ILS PPR, which is submitted 

annually by the SILC and DSE in every 

state, territory, and commonwealth. 

ACL uses the ILS PPR to assess grantee 

compliance with title VII of the Act, 

with 45 CFR part 1329 of the Code of 

Federal Regulations, and with 

applicable provisions of the HHS 

Regulations at 45 CFR part 75. The ILS 

PPR serves as the primary basis for 

ACL’s monitoring activities in 

fulfillment of its responsibilities under 

sections 706 and 722 of the Act. ACL 

also uses the PPR to identify training 

and technical assistance needs for SILCs 

and centers for independent living. 

To view the data collection activity 

for this information collection request, 

please visit the ACL public input 

website: https://www.acl.gov/about-acl/ 

public-input. 

Estimated Program Burden 

ACL estimates the burden of this 

collection of information as follows: 

Fifty-six jurisdictions—specifically, the 

fifty states, Puerto Rico, the District of 

Columbia, American Samoa, the 

Commonwealth of the Northern Mariana 

Islands, Guam, and the US Virgin 

Islands—will each complete ILS PPRs 

annually, and it will take an estimated 

thirty-five hours per jurisdiction per ILS 

PPR. Each jurisdiction’s SILC and DSE 

will collaborate to complete the ILS 

PPR. The fifty-six jurisdictions, 

combined, will take an estimated 1,960 

hours per year to complete ILS PPRs. 

This burden estimate is based on what 

DSEs and SILCs have told ACL about 

how long filling out ILS PPRs took in 

previous reporting years. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Total annual 

burden hours 

SILCs and DSEs .............................................................................................. 56 1 35 1,960 

Dated: December 10, 2020. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2020–27734 Filed 12–16–20; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3679] 

Interacting With the Food and Drug 

Administration on Complex Innovative 

Trial Designs for Drugs and Biological 

Products; 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 entitled ‘‘Interacting with the 

FDA on Complex Innovative Trial 

Designs for Drugs and Biological 

Products.’’ The guidance provides 

recommendations to sponsors and 

applicants on interacting with FDA on 

complex innovative trial design (CID) 

proposals for drugs or biological 

products. FDA is issuing this guidance 

to satisfy, in part, a mandate under the 

21st Century Cures Act (Cures Act). In 

accordance with the Cures Act mandate, 

this guidance discusses the use of novel 

trial designs in the development and 

regulatory review of drugs and 

biological products, how sponsors may 

obtain feedback on technical issues 

related to modeling and simulation, and 

81926 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 

the types of quantitative and qualitative 

information that should be submitted 

for review. The guidance announced in 

this notice finalizes the draft guidance 

of the same title dated September 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 17, 2020. 

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– 

2019–D–3679 for ‘‘Interacting with the 

FDA on Complex Innovative Trial 

Designs for Drugs and Biological 

Products.’’ 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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Shruti Modi, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911; or Scott Goldie, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 3557, 

Silver Spring, MD 20993–0002, 301– 

796–2055. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Interacting with 

the FDA on Complex Innovative Trial 

Designs for Drugs and Biological 

Products.’’ The guidance provides 

recommendations to sponsors and 

applicants on interacting with FDA on 

CID proposals for drugs or biological 

products. FDA is issuing this guidance 

to satisfy, in part, a mandate under 

section 3021 of the Cures Act (Pub. L. 

114–255). In accordance with the Cures 

Act mandate, the guidance discusses the 

use of novel trial designs in the 

development and regulatory review of 

drugs and biological products, how 

sponsors may obtain feedback on 

technical issues related to modeling and 

simulation, and the types of quantitative 

and qualitative information that should 

be submitted for review. 

In the Federal Register of September 

23, 2019 (84 FR 49743), FDA announced 

the availability of the draft guidance of 

the same title dated September 2019. 

FDA received several comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. Changes made to the guidance 

include the incorporation of example 

CID proposals submitted to FDA’s CID 

Pilot Program, and revision of the 

discussion of alternative operating 

characteristics for Bayesian trial 

designs. In addition, editorial changes 

were made to improve clarity. The 

guidance announced in this notice 

finalizes the draft guidance dated 

September 2019. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Interacting with 

the FDA on Complex Innovative Trial 

Designs for Drugs and Biological 

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 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 81927 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved collections of 

information found in FDA regulations. 

Therefore, clearance by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3521) is not 

required for this guidance. The 

previously approved collections of 

information are subject to review by the 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, or https://

www.regulations.gov. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27813 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2214] 

Dry Eye: Developing Drugs for 

Treatment; 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 ‘‘Dry Eye: 

Developing Drugs for Treatment.’’ The 

purpose of this draft guidance is to 

foster greater efficiency in drug 

development for this disease, which 

currently has few effective treatment 

options. The goal is to enhance clinical 

trial data quality and to support the 

development of treatments for dry eye 

conditions. Specifically, the draft 

guidance provides the Agency’s current 

recommendations regarding eligibility 

criteria, trial design considerations, and 

efficacy endpoints for use in clinical 

development programs of 

investigational drugs to treat dry eye 

conditions. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 17, 2021 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– 

2020–D–2214 for ‘‘Dry Eye: Developing 

Drugs for Treatment.’’ 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 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