2952 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Proposed Rules 

appropriate to the product. Any 

advertised R-value claims must fairly 

reflect the results of those tests. For the 

purposes of this section, fenestrationrelated products include windows, 

doors, and skylights as well as 

attachments for those products. 

■ 14. In Appendix to Part 460— 

Exemptions, add paragraph (d) to read 

as follows: 

In Appendix to Part 460—Exemptions 

* * * * * 

(d) The requirements in §§ 460.6 through 

460.21 of this part do not apply to R-value 

claims covered by § 460.22. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2017–26569 Filed 1–19–18; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2017–N–5319] 

Devices Proposed for a New Use With 

an Approved, Marketed Drug; Public 

Hearing; Reopening of the Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

reopening of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is reopening the comment period 

for the document published in the 

Federal Register on September 26, 2017, 

announcing a public hearing on a 

potential approach for device sponsors 

who seek to obtain marketing 

authorization for their products that are 

intended for a new use with an 

approved, marketed drug when the 

sponsor for the approved, marketed 

drug does not wish to pursue or 

collaborate on the new use. In the 

document, in addition to seeking 

comments on the potential approach, 

FDA also welcomed comments on 

public health, scientific, regulatory, or 

legal considerations relating to other 

medical products intended for new uses 

with approved, marketed medical 

products of a different type where the 

sponsor for the approved, marketed 

product does not wish to pursue or 

collaborate on the new use. We are 

reopening the comment period in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is reopening the comment 

period on the document published on 

September 26, 2017 (82 FR 44803). 

Submit either electronic or written 

comments by February 21, 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 February 21, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of February 21, 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– 

2017–N–5319 for ‘‘Devices Proposed for 

a New Use With an Approved, Marketed 

Drug; Public Hearing; Request for 

Comments.’’ 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: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 


ethrower on DSK3G9T082PROD with PROPOSALS
Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Proposed Rules 2953 

MD 20993, 301–796–8930, 

combination@fda.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register on September 26, 2017 

(82 FR 44803), FDA published a 

document announcing a public hearing 

on November 16, 2017, regarding a 

potential approach for device sponsors 

who seek to obtain marketing 

authorization for their products that are 

intended for a new use with an 

approved, marketed drug when the 

sponsor for the approved, marketed 

drug does not wish to pursue or 

collaborate on the new use. The purpose 

of the public hearing was to obtain 

comments from stakeholders on the 

potential approach presented in the 

Federal Register document as well as 

comments on public health, scientific, 

regulatory, or legal considerations 

relating to other medical products 

intended for new uses with approved, 

marketed medical products of a 

different type where the sponsor for the 

approved, marketed product does not 

wish to pursue or collaborate on the 

new use. We sought this type of public 

engagement because of the potential 

importance of the issue for public health 

and the need for input across the 

medical product industry and among 

public health stakeholders regarding 

how FDA should proceed. The 

comments that FDA receives in relation 

to this public hearing may help inform 

the further development of this 

approach. 

The document stated that comments 

would be accepted until January 15, 

2018, and that untimely comments 

would not be considered. Near the end 

of the comment period, we received a 

request, submitted on behalf of several 

potential commenters, for more time to 

develop comments. We have considered 

this request and are reopening the 

comment period for an additional 30 

days. We believe that this reopening 

allows adequate time for interested 

persons to submit comments without 

delaying further Agency efforts on this 

topic. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00991 Filed 1–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 901 

[SATS No. AL–082–FOR; Docket ID: OSM– 

2017–0011; S1D1S SS08011000 SX064A000 

189S180110; S2D2S SS08011000 

SX064A000 18XS501520] 

Alabama Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing on proposed amendment. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSMRE), are announcing receipt of a 

proposed amendment to the Alabama 

regulatory program (Alabama program) 

under the Surface Mining Control and 

Reclamation Act of 1977 (SMCRA or the 

Act). Alabama proposes revisions to its 

program regarding annual permit fees. 

Alabama revised its program at its own 

initiative to raise revenues sufficient to 

fund the Alabama Surface Mining 

Commission’s (ASMC) share of costs to 

administer their coal regulatory 

program, including the cost of 

reviewing, administering, inspecting, 

and enforcing surface coal mining 

permits in Alabama. 

This document gives the locations 

and times where the Alabama program 

documents and proposed amendment to 

that program are available for your 

inspection, establishes the comment 

period during which you may submit 

written comments on the amendment, 

and describes the procedures we will 

follow for the public hearing, if one is 

requested. 

DATES: We will accept written 

comments on this amendment until 4:00 

p.m., CST, February 21, 2018. If 

requested, we will hold a public hearing 

about the amendment on February 16, 

2018. We will accept requests to speak 

at a hearing until 4:00 p.m., CST on 

February 6, 2018. 

ADDRESSES: You may submit comments, 

identified by SATS No. AL–082–FOR, 

by any of the following methods: 

• Mail/Hand Delivery: William 

Joseph, Acting Director, Birmingham 

Field Office, Office of Surface Mining 

Reclamation and Enforcement, 135 

Gemini Circle, Suite 215, Homewood, 

Alabama 35209. 

• Fax: (205) 290–7280. 

• Federal eRulemaking Portal: The 

amendment has been assigned Docket 

ID OSM–2017–0011. If you would like 

to submit comments go to http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Comment Procedures’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

review copies of the Alabama program, 

this amendment, a listing of any 

scheduled public hearings, and all 

written comments received in response 

to this document, you must go to the 

address listed below during normal 

business hours, Monday through Friday, 

excluding holidays. You may receive 

one free copy of the amendment by 

contacting OSMRE’s Birmingham Field 

Office or the full text of the program 

amendment is available for you to 

review at www.regulations.gov. 

William Joseph, Acting Director, 

Birmingham Field Office, Office of 

Surface Mining Reclamation and 

Enforcement, 135 Gemini Circle, Suite 

215, Homewood, Alabama 35209, 

Telephone: (205) 290–7282, email: 

bjoseph@osmre.gov. 

In addition, you may review a copy of 

the amendment during regular business 

hours at the following location: 

Alabama Surface Mining Commission, 

1811 Second Ave., P.O. Box 2390, 

Jasper, Alabama 35502–2390, 

Telephone: (205) 221–4130. 

FOR FURTHER INFORMATION CONTACT: 

William Joseph, Acting Director, 

Birmingham Field Office. Telephone: 

(205) 290–7282, email: bjoseph@

osmre.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Alabama Program 

II. Description of the Proposed Amendment 

III. Public Comment Procedures 

IV. Procedural Determinations 

I. Background on the Alabama Program 

Section 503(a) of the Act permits a 

State to assume primacy for the 

regulation of surface coal mining and 

reclamation operations on non-Federal 

and non-Indian lands within its borders 

by demonstrating that its program 

includes, among other things, state laws 

and regulations that govern surface coal 

mining and reclamation operations in 

accordance with the Act and consistent 

with the Federal regulations. See 30 

U.S.C. 1253(a)(1) and (7). On the basis 

of these criteria, the Secretary of the 

Interior conditionally approved the 

Alabama program effective May 20, 

1982. You can find background 

information on the Alabama program, 


ethrower on DSK3G9T082PROD with PROPOSALS