2758 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 7 

[Docket No. FDA–2016–D–3548] 

Public Warning and Notification of 

Recalls Under 21 CFR Part 7, Subpart 

C; Draft Guidance for Industry and 

Food and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance entitled ‘‘Public Warning and 

Notification of Recalls Under 21 CFR 

Part 7, Subpart C; Draft Guidance for 

Industry and FDA Staff.’’ The draft 

guidance, when finalized, establishes 

official guidance for industry and FDA 

staff regarding the use, content, and 

circumstances for issuance of public 

warnings and public notification of 

voluntary recalls under Federal 

regulations. The intent of the draft 

guidance is to increase and expedite the 

appropriate and accurate use of public 

warnings and public notification, to 

increase public health protection by 

better informing the public about 

violative products being recalled. The 

draft guidance clarifies and 

supplements existing policy for industry 

and FDA staff regarding the use of 

public warnings and public notification. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 20, 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draft guidance before it begins work on 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– 

2016–D–3548 for ‘‘Public Warning and 

Notification of Recalls Under 21 CFR 

Part 7, Subpart C; Draft Guidance for 

Industry and FDA Staff.’’ 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 Office 

of Strategic Planning and Operational 

Policy, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr., Element Building, 

Rockville, MD 20857. Send one selfaddressed 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 Henderson, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Dr., Rockville, MD 

20857, 240–402–8186, 

Christopher.henderson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Public Warning and 

Notification of Recalls Under 21 CFR 

Part 7, Subpart C.’’ The draft guidance, 

when finalized, will establish official 

guidance for industry and FDA staff 

regarding the use, content, and timing of 

public warnings and public notification 

of recalls under part 7 (21 CFR part 7). 

The draft guidance is part of a larger 

effort FDA is undertaking to give 

additional guidance to industry and 

FDA staff regarding the execution and 

oversight of voluntary recalls under part 

7. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on public warnings and notification of 

recalls. It does not establish any rights 

for any person and is not binding on 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 2759 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This draft guidance is 

not subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). Any 

collection of information, including a 

firm’s public warning (§ 7.42(b)(2)), has 

been approved under OMB control 

number 0910–0249. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Safety/Recalls/ 

default.htm or https://

www.regulations.gov. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00918 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

37 CFR Parts 1 and 42 

[Docket No.: PTO–P–2017–0034] 

RIN 0651–AD25 

Changes To Eliminate Unnecessary 

Regulations 

AGENCY: United States Patent and 

Trademark Office, Commerce. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The United States Patent and 

Trademark Office (USPTO or Office) 

proposes to remove its regulations 

governing reservation clauses, petitions 

from the refusal of a primary examiner 

to admit an amendment, the publication 

of amendments to the regulations, and 

limits that the Director can impose on 

the number of inter partes reviews and 

post-grant reviews heard by the Patent 

Trial and Appeal Board. These 

regulations are unnecessary or 

superfluous and in some cases have 

expired, and their removal will help 

streamline USPTO’s body of regulations 

without reducing the availability of 

services for the public. This proposed 

rule arises out of the USPTO’s work 

during FY 2017 to identify and propose 

regulations for removal, modification, 

and streamlining because they are 

outdated, unnecessary, ineffective, 

costly, or unduly burdensome on the 

agency or the private sector. The 

revisions proposed herein would put 

into effect the work the USPTO has 

done, in part through its participation in 

the Regulatory Reform Task Force 

established by the Department of 

Commerce pursuant to Executive Order 

13777, to review and identify 

regulations that are candidates for 

removal. 

DATES: Written comments must be 

received on or before February 20, 2018. 

ADDRESSES: Comments on the changes 

set forth in this proposed rulemaking 

should be sent by electronic mail 

message to: AD25.comments@uspto.gov. 

Comments may also be submitted by 

postal mail addressed to: Mail Stop 

Comments—Patents, Commissioner for 

Patents, P.O. Box 1450, Alexandria, VA, 

22313–1450, marked to the attention of 

Raul Tamayo, Senior Legal Advisor, 

Office of Patent Legal Administration. 

Comments concerning ideas to improve, 

revise, and streamline other USPTO 

regulations, not discussed in this 

proposed rulemaking, should be 

submitted to: RegulatoryReformGroup@

uspto.gov. 

Comments may also be submitted via 

the Federal eRulemaking Portal at 

http://www.regulations.gov. See the 

Federal eRulemaking Portal website for 

additional instructions on providing 

comments via the Federal eRulemaking 

Portal. Although comments may be 

submitted by postal mail, the Office 

prefers to receive comments by 

electronic mail message over the 

internet because the Office may easily 

share such comments with the public. 

Electronic comments are preferred to be 

submitted in plain text, but also may be 

submitted in ADOBE® portable 

document format or MICROSOFT 

WORD® format. Comments not 

submitted electronically should be 

submitted on paper in a format that 

facilitates convenient digital scanning 

into ADOBE® portable document 

format. 

The comments will be available for 

public inspection at the Office of the 

Commissioner for Patents, currently 

located in Madison East, 600 Dulany 

Street, Alexandria, Virginia. Comments 

also will be available for viewing via the 

Office’s internet website (http://

www.uspto.gov) and at http://

www.regulations.gov. Because 

comments will be made available for 

public inspection, information that the 

submitter does not desire to make 

public, such as an address or phone 

number, should not be included in the 

comments. 

FOR FURTHER INFORMATION CONTACT: Raul 

Tamayo, Senior Legal Advisor, Office of 

Patent Legal Administration, at (571) 

272–7728, for questions regarding the 

changes to 37 CFR 1.79 and/or 1.127; 

Susan L. C. Mitchell, Lead 

Administrative Patent Judge, Patent 

Trial and Appeal Board, at (571) 272– 

8715, for questions regarding the 

changes to 37 CFR part 42; and Nicolas 

Oettinger, Senior Counsel for Regulatory 

and Legislative Affairs, Office of the 

General Counsel, at (571) 272–7832, for 

questions regarding the change to 37 

CFR 1.351 and general questions 

regarding regulatory reform. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with Executive Order 

13777, ‘‘Enforcing the Regulatory 

Reform Agenda,’’ the Department of 

Commerce established a Regulatory 

Reform Task Force (Task Force), 

comprising, among others, agency 

officials from the National Oceanic and 

Atmospheric Administration, the 

Bureau of Industry and Security, and 

the USPTO, and charged the Task Force 

with evaluating existing regulations and 

identifying those that should be 

repealed, replaced, or modified because 

they are potentially outdated, 

unnecessary, ineffective, costly, or 

unduly burdensome to both government 

and private sector operations. 

To support its regulatory reform 

efforts on the Task Force, the USPTO 

assembled a Working Group on 

Regulatory Reform (Working Group), 

consisting of subject matter experts from 

each of the business units that 

implement the USPTO’s regulations, to 

consider, review, and recommend ways 

that the regulations could be improved, 

revised, and streamlined. In considering 

the revisions, the USPTO, through its 

Working Group, incorporated into its 

analyses all presidential directives 

relating to regulatory reform. The 

Working Group reviewed existing 

regulations, both discretionary and 

required by statute or judicial order. The 

USPTO also solicited comments from 

stakeholders through a web page 

established to provide information on 

the USPTO’s regulatory reform efforts, 

and through the Department’s Federal 

Register Notice titled ‘‘Impact of Federal 

Regulations on Domestic 

Manufacturing’’ (82 FR 12786, Mar. 7, 

2017), which addressed the impact of 

regulatory burdens on domestic 

manufacturing. These efforts led to the 

development of candidate regulations 

for removal based on the USPTO’s 

assessment that these regulations were 

not needed and/or that elimination 


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