Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42499 

TABLE 1—FORMAT FOR SUBMITTING COMMENTS

Name of regulation 

Type of product or FDA Center regulating the product. 

Citation to Code of Federal Regulations and statutory citation (as applicable). 

Approved information collection and OMB Control Number (as applicable). 

Brief description of concern ...................................................................... (For example, what innovation makes the regulation outdated? Why?) 

Available data on cost or economic impact ............................................. (Quantified costs and/or cost savings. Qualitative description, if needed.) 

Proposed solution ..................................................................................... (Include your solution. For example, how would you modify the regulation? Provide specific text if you are recommending a modification.) 

III. References 

The following references are on 

display in the Dockets Management 

Staff Office (see ADDRESSES) and are 

available for viewing by interested 

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

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. Executive Order 13771 (January 30, 2017); 

available at https://

www.federalregister.gov/documents/ 

2017/02/03/2017-02451/reducingregulation-and-controlling-regulatorycosts. 

2. Executive Order 13777 (February 24, 

2017); available at https://

www.federalregister.gov/documents/ 

2017/03/01/2017-04107/enforcing-theregulatory-reform-agenda. 

Dated: August 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19031 Filed 9–7–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2017–N–5101] 

Review of Existing Center for Drug 

Evaluation and Research Regulatory 

and Information Collection 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for comments and 

information. 

SUMMARY: As part of the implementation 

of Executive Order 13771 entitled, 

‘‘Reducing Regulation and Controlling 

Regulatory Costs,’’ and Executive Order 

13777 entitled, ‘‘Enforcing the 

Regulatory Reform Agenda,’’ the Food 

and Drug Administration (FDA, Agency, 

or we) is seeking comments and 

information from interested parties to 

help FDA identify existing regulations 

and related paperwork requirements 

that could be modified, repealed, or 

replaced, consistent with the law, to 

achieve meaningful burden reduction 

while allowing us to achieve our public 

health mission and fulfill statutory 

obligations. This document relates to 

the products regulated by the Center for 

Drug Evaluation and Research (CDER). 

DATES: Submit either electronic or 

written comments on this document by 

December 7, 2017. 

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 December 7, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 7, 2017. 

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–5101 for ‘‘Review of Existing 

Center for Drug Evaluation and Research 

Regulatory and Information Collection 

Requirements.’’ 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 

Office 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.’’ We 

will review this copy, including the 


sradovich on DSK3GMQ082PROD with PROPOSALS
42500 Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 

claimed confidential information, in our 

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 Office, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christine Kirk, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–2465, christine.kirk@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. FDA’s Regulatory Mission 

FDA is responsible for protecting the 

public health by: (1) Ensuring the safety, 

efficacy, and security of human and 

veterinary drugs, biological products, 

and medical devices; (2) ensuring the 

safety, security, and appropriate 

labeling of our nation’s food supply, 

products that emit radiation, and 

cosmetics; and (3) regulating the 

manufacture, marketing, and 

distribution of tobacco products. 

Equally important, FDA promotes the 

public health by fostering and 

supporting innovative approaches and 

solutions for some of our nation’s most 

compelling health and medical 

challenges. 

FDA’s CDER regulates over-thecounter and prescription drugs, 

including therapeutic biological 

products and generic drugs. This 

document is seeking comments and 

information solely on regulations and 

approved information collections 

related to these product areas. 

B. The Regulatory Reform Agenda: 

Executive Orders 13771 and 13777 

On January 30, 2017, President Trump 

issued Executive Order 13771, 

‘‘Reducing Regulation and Controlling 

Regulatory Costs’’ (Ref. 1). This 

Executive Order states that the policy of 

the Executive Branch is to be prudent 

and financially responsible in the 

expenditure of funds, from both public 

and private sources, and that it is 

essential to manage the costs associated 

with complying with Federal 

regulations. On February 24, 2017, 

President Trump issued Executive 

Order 13777, entitled ‘‘Enforcing the 

Regulatory Reform Agenda’’ (Ref. 2). 

The purpose of this Executive Order is 

to alleviate unnecessary regulatory 

burdens placed on the American people. 

Executive Order 13777 directs each 

Agency to establish a Regulatory Reform 

Task Force (RRTF) to evaluate existing 

regulations and identify those that may 

merit repeal, replacement, or 

modification. Section 3(d) of the 

Executive Order provides that, at a 

minimum, each RRTF must attempt to 

identify regulations that: 

• Eliminate jobs, or inhibit job 

creation; 

• Are outdated, unnecessary, or 

ineffective; 

• Impose costs that exceed benefits; 

• Create a serious inconsistency or 

otherwise interfere with regulatory 

reform initiatives and policies; 

• Are inconsistent with the 

requirements of the Information Quality 

Act, or the guidance issued pursuant to 

that Act, in particular those regulations 

that rely in whole or in part on data, 

information, or methods that are not 

publicly available or that are 

insufficiently transparent to meet the 

standard for reproducibility; or 

• Derive from or implement 

Executive Orders or other Presidential 

directives that have been subsequently 

rescinded or substantially modified. 

II. Request for Comments and 

Information 

To assist with our implementation of 

Executive Orders 13771 and 13777 and 

support the work of the RRTF of the 

Department of Health and Human 

Services, FDA is issuing this Request for 

Information soliciting broad public 

comment on ways we can change our 

regulations to achieve meaningful 

burden reduction while continuing to 

achieve our public health mission and 

fulfill statutory obligations. We request 

comment, including supporting 

technical, scientific, economic, or other 

data, from all persons and entities 

significantly affected by FDA 

regulations, including consumers, 

patients and caregivers, researchers, 

healthcare institutions, the regulated 

industry, trade associations, public 

interest organizations, academia, and 

State, local, and tribal governments, as 

well as any other interested stakeholder. 

These comments and data will 

supplement and inform our own 

ongoing, systematic review of our 

regulations. 

The following list of questions 

includes those that FDA is using to 

guide our initial review of our 

regulations. This list is intended to help 

the public in providing comments, not 

to restrict the issues that may be 

addressed. 

• Is the regulation still current, or is 

it outdated or unnecessary in some way? 

Æ Have there been advancements and 

innovations in science, technology, or 

FDA or industry practice, or any other 

changes that suggest repeal of or 

modification to the regulation may be 

warranted or appropriate? 

Æ Has the regulation been superseded 

or made irrelevant or unenforceable by 

statute, another FDA regulation or 

guidance, a regulation by another 

Federal Agency, or controlling legal 

authority? If yes, identify the statute, 

regulation, guidance, or legal precedent 

and explain what FDA regulation is 

affected and in what way it is affected. 

Æ Is this regulation duplicative of 

requirements in other FDA regulations 

or other Federal Agency regulations? If 

yes, identify the overlapping 

regulation(s) and responsible Federal 

Agency and describe the way(s) in 

which the regulations overlap, as well 

as any suggestions with respect to how 

best to resolve the duplication. 

• Have regulated entities had 

difficulties complying with the 

regulation? If yes, identify what entity 

or entities have had such difficulties 

and the nature of the difficulties. 

• Does the regulation impose 

requirements that are also provided for 

in voluntary or consensus standards or 

guidance by third party organizations 

(e.g., International Council for 

Harmonisation, International 

Organization for Standardization, Codex 

Alimentarius)? Do the entities covered 

by these standards or guidance take 

steps to meet the standards and to 

document that they meet the standards? 

If met, do the standards achieve the 

same level of public health protection as 

the FDA regulation? Are there entities 

who are not covered by these standards 

or guidances or who choose not to 

observe them? 


sradovich on DSK3GMQ082PROD with PROPOSALS
Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42501 

• Does the regulation contain 

redundant, outdated, or unnecessary 

collections of information or retention 

of records, e.g., reporting, 

recordkeeping, or labeling 

requirements? Explain in your response 

why the information is redundant, 

outdated, or unnecessary. 

• Could the goal of the regulation be 

achieved by less costly means that 

would provide the same level of public 

health protection? If yes, provide 

examples of alternatives that may 

reduce costs to industry while retaining 

the same level of public health 

protection. 

• What factors should FDA consider 

in selecting and prioritizing regulations 

and reporting requirements for reform? 

The most current version of FDA 

regulations may be found at https://

www.ecfr.gov. We request that 

comments be as specific as possible, 

include any supporting data or other 

information, such as cost information, 

provide a Code of Federal Regulations 

(CFR) citation when referencing a 

specific regulation, and provide specific 

suggestions regarding repeal, 

replacement, or modification. For 

comments relating to an information 

collection, cite to the approved 

information collection request and 

include the Office of Management and 

Budget (OMB) control number. 

In addition, in order to enable us to 

more efficiently review and consider 

comments, we ask that the comments be 

submitted in the format shown in table 

1 of this document. 

TABLE 1—FORMAT FOR SUBMITTING COMMENTS

Name of regulation 

Type of product or FDA Center regulating the product. 

Citation to Code of Federal Regulations and statutory citation (as applicable).

Approved information collection and OMB Control Number (as applicable).

Brief description of concern ...................................................................... (For example, what innovation makes the regulation outdated? Why?) 

Available data on cost or economic impact ............................................. (Quantified costs and/or cost savings. Qualitative description, if needed.) 

Proposed solution ..................................................................................... (Include your solution. For example, how would you modify the regulation? Provide specific text if you are recommending a modification.) 

III. References 

The following references are on 

display in the Dockets Management 

Staff Office (see ADDRESSES) and are 

available for viewing by interested 

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

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. Executive Order 13771 (January 30, 2017); 

available at https://

www.federalregister.gov/documents/

2017/02/03/2017-02451/reducingregulation-and-controlling-regulatorycosts. 

2. Executive Order 13777 (February 24, 

2017); available at https://

www.federalregister.gov/documents/

2017/03/01/2017-04107/enforcing-theregulatory-reform-agenda. 

Dated: August 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19033 Filed 9–7–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2017–N–5095] 

Review of Existing Center for Tobacco 

Products Regulatory and Information 

Collection Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for comments and 

information. 

SUMMARY: As part of the implementation 

of Executive Order 13771 entitled, 

‘‘Reducing Regulation and Controlling 

Regulatory Costs,’’ and Executive Order 

13777 entitled, ‘‘Enforcing the 

Regulatory Reform Agenda,’’ the Food 

and Drug Administration (FDA, Agency, 

or we) is seeking comments and 

information from interested parties to 

help FDA identify existing regulations 

and related paperwork requirements 

that could be modified, repealed, or 

replaced, consistent with the law, to 

achieve meaningful burden reduction 

while allowing us to achieve our public 

health mission and fulfill statutory 

obligations. This document relates to 

the products regulated by the Center for 

Tobacco Products (CTP). 

DATES: Submit either electronic or 

written comments on this document by 

December 7, 2017. 

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 December 7, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 7, 2017. 

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 


sradovich on DSK3GMQ082PROD with PROPOSALS