66278 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

Centers for Independent Living 

Program Performance Report (0985– 

NEW) 

AGENCY: Administration for Community 

Living (ACL), HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

that the proposed collection of 

information listed above has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance as required under section 

506(c)(2)(A) of the Paperwork Reduction 

Act of 1995. This 30-Day notice collects 

comments on the information collection 

requirements related to Centers for 

Independent Living Program 

Performance Report (New Data 

Collection (ICR New)). 

DATES: Comments on the information 

collection request must be submitted 

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

postmarked by January 25, 2019. 

ADDRESSES: Submit written comments 

on the collection of information by: 

(a) email to: OIRA_submission@

omb.eop.gov, Attn: OMB Desk Officer 

for ACL; 

(b) fax to 202.395.5806, Attn: OMB 

Desk Officer for ACL; or 

(c) by mail to the Office of 

Information and Regulatory Affairs, 

OMB, New Executive Office Bldg., 725 

17th St. NW, Rm. 10235, Washington, 

DC 20503, Attn: OMB Desk Officer for 

ACL. 

FOR FURTHER INFORMATION CONTACT: 

Peter Nye, Administration for 

Community Living, Washington, DC 

20201, (202) 795–7606 or peter.nye@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, ACL 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. The Act of 1973 

requires three Independent Living 

program reports: (1) State Plan for 

Independent Living, (2) Independent 

Living Services (ILS) Program 

Performance Report (PPR), and (3) 

Centers for Independent Living (CIL) 

PPR. The ILS PPR and CIL PPR were 

previously combined into one 

submission. However, for the purposes 

of this data collection, the ILS PPR and 

CIL PPR are being submitted separately 

because they are separate collections of 

different information from different 

parties. This will result in a new OMB 

approval number for the CIL program. 

Separating these PRA processes reduces 

confusion and increases the 

Independent Living Administration’s 

(ILA) ability to identify issues specific 

to DSEs and Statewide Independent 

Living Councils. This request is for the 

CIL PPR, which is submitted annually 

by all CILs receiving Subchapter C 

funds. The CIL PPRs are used by ACL 

to assess grantees’ 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 CIL 

PPR serves as the primary basis for 

ACL’s monitoring activities in 

fulfillment of its responsibilities under 

sections 706 and 722 of the Act. The CIL 

PPR enables ACL to track performance 

outcomes and efficiency measures of the 

CIL programs with respect to the annual 

and long-term performance targets 

established in compliance with GPRA. 

The PPR is also used by ACL to design 

CIL and SILC training and technical 

assistance programs authorized by 

section 721 of the Act. 

The current version of the CIL PPR 

that ILA is requesting an extension for 

was approved by OMB, but will expire 

on December 31, 2018. ILA plans to 

publish a revised CIL program data 

collection instrument before the 

expiration of the extension request. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice was published in the Federal 

Register on October 19, 2018 (Vol. 83, 

Number 2018–22754; pp. 53064–53065). 

We received a comment that applied 

to this notice, as indicated below. 

Data collection form Comment ACL Response 

One commenter asked whether ACL has an update on 

the publication of the revised CIL indicators.

ACL has no update on the publication of the revised 

CIL indicators.

No change has been made. 

The proposed form(s) may be found 

on the ACL website at https://

www.acl.gov/about-acl/public-input. 

Estimated Program Burden 

ACL estimates the burden of this 

collection of information as follows: 353 

Centers for Independent Living will 

each complete one CIL PPR annually, 

and it will take an estimated 35 hours 

per CIL for an estimated total of 12,355 

hours. This burden estimate is based 

partly on ILA’s estimates of how long 

CILs take to find the information that 

PPRs ask for and partly on what CILs 

have told ILA about how long CILs 

spend filling out PPRs. 

TABLE 37—RANGE TO EFFECTS (METERS) FROM AIR GUNS FOR 1 PULSE

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual burden 

hours 

Centers for Independent Living ....................................................................... 353 1 35 12,355 

Total .......................................................................................................... 353 1 35 12,355 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 66279 

Dated: December 18, 2018. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2018–27898 Filed 12–21–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–E–5040] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ADLYXIN 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined the regulatory review period 

for ADLYXIN and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by February 25, 2019. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 24, 2019. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 February 25, 

2019. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 25, 2019. 

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– 

2017–E–5040 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; ADLYXIN.’’ 

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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION:

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 


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