42098 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Crew Members .................................. Interview protocol ............................. 250 1 10/60 42 

Total ........................................... ........................................................... ........................ ........................ ........................ 44 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–18814 Filed 9–5–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4642] 

B. Braun Medical, Inc.; Withdrawal of 

Approval of Three New Drug 

Applications and One Abbreviated New 

Drug Application; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document entitled ‘‘B. Braun Medical, 

Inc.; Withdrawal of Approval of Three 

New Drug Applications and One 

Abbreviated New Drug Application’’ 

that appeared in the Federal Register of 

August 3, 2017 (82 FR 36150). The 

document was published with the 

incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy, Food and Drug 

Administration, Bldg. 32, Rm. 3330, 

Silver Spring, MD 20993–0002, 301– 

796–9115. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Thursday, August 3, 

2017, in FR Doc. 2017–16377, on page 

36150, the following correction is made: 

1. On page 36150, in the second 

column, in the header of the document, 

‘‘Docket No. FDA–2017–N–0002’’ is 

corrected to read ‘‘Docket No. FDA– 

2017–N–4642’’. 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18813 Filed 9–5–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4625] 

Development of a List of Pre-Dietary 

Supplement Health and Education Act 

Dietary Ingredients; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the following public 

meeting entitled ‘‘Development of a List 

of Pre-DSHEA Dietary Ingredients.’’ The 

purpose of the meeting is to give 

interested stakeholders an opportunity 

to discuss issues related to FDA’s future 

development of such a list. 

DATES: The public meeting will be held 

on October 3, 2017, from 8 a.m. to 5 

p.m. Submit either electronic or written 

comments on this public meeting by 

December 4, 2017. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at FDA’s Center for Food Safety 

and Applied Nutrition, Wiley 

Auditorium, 5001 Campus Dr., College 

Park, MD 20740. 

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 4, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of December 4, 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–4625 for ‘‘Development of a 

List of Pre-DSHEA Dietary Ingredients; 

Public Meeting; 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42099 

1https://www.fda.gov/food/guidanceregulation/ 

guidancedocumentsregulatoryinformation/ 

dietarysupplements/ucm257563.htm. 

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 

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, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Juanita Yates, Center for Food Safety 

and Applied Nutrition (HFS–009), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

1731, email: Juanita.yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 12, 

2016 (81 FR 53486), we issued a notice 

announcing the availability of a revised 

draft guidance for industry entitled, 

‘‘Dietary Supplements: New Dietary 

Ingredient Notifications and Related 

Issues.’’ 1 The revised draft guidance, 

when finalized, will help industry in 

evaluating whether to submit a 

premarket safety notification for a new 

dietary ingredient (NDI), or for a dietary 

supplement containing an NDI, and in 

preparing such premarket safety 

notifications (also referred to as NDI 

notifications). The Dietary Supplement 

Health and Education Act of 1994 

(DSHEA) (Pub. L. 103–417) amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) by adding, among other 

provisions: (1) Section 201(ff) of the 

FD&C Act (21 U.S.C. 321(ff)), which 

defines the term ‘‘dietary supplement’’ 

and (2) section 413 of the FD&C Act (21 

U.S.C. 350(b)), which describes 

requirements for NDIs. Under DSHEA, 

dietary ingredients marketed in the 

United States before October 15, 1994, 

are not NDIs and therefore are not 

subject to the premarket notification 

requirements in section 413 of the FD&C 

Act. The revised draft guidance 

addressed, among other things, 

considerations related to determining 

when a dietary ingredient is not new 

and therefore does not require a NDI 

notification. 

In the revised draft guidance, we 

stated our willingness to compile an 

authoritative list of pre-October 15, 

1994, dietary ingredients based on 

independent and verifiable data to be 

supplied by industry. Although we are 

aware that several trade associations 

and industry groups have 

independently developed their own 

unofficial lists of ingredients that they 

believe were marketed before October 

15, 1994 (sometimes referred to as 

‘‘grandfathered’’ or ‘‘old’’ dietary 

ingredients), we are unable to verify the 

accuracy of those lists and therefore 

have never recognized or sanctioned 

any of them. We also have never 

compiled our own list. 

An authoritative list would provide 

benefits to both industry and FDA. By 

providing clarity as to which 

ingredients do not require notifications, 

it would alleviate the burden on 

industry of preparing and submitting 

unnecessary notifications. Similarly, by 

eliminating unnecessary notifications, 

an authoritative list would enable us to 

more efficiently use our limited 

resources to review notifications for 

truly ‘‘new’’ ingredients. In addition, an 

authoritative list would allow us to 

better focus our enforcement efforts in 

alignment with our strategic priorities of 

consumer safety, product integrity, and 

accurate information. 

We have received and are reviewing 

comments on the 2016 revised draft 

guidance. The comments generally 

support the idea that we should develop 

a list of pre-DSHEA dietary ingredients, 

but reflect opinions both on the 

standard of evidence for demonstrating 

that an ingredient is pre-DSHEA and on 

the process by which ingredients should 

be added to the list. We believe that 

public discussion of these issues will be 

beneficial as we work toward 

development of a list of pre-DSHEA 

dietary ingredients. 

II. Topics for Discussion at the Public 

Meeting 

The public meeting will have two 

separate panels. Each panel will be 

followed by an opportunity for open 

public comment. In addition, there will 

be an opportunity for interested 

stakeholders to submit additional 

written comments following the 

meeting. 

The first panel will discuss what 

standard of evidence is necessary to 

determine that an ingredient was 

marketed before October 15, 1994. This 

panel may address, among other things, 

what types and quantity of evidence 

may suffice to demonstrate that a 

dietary ingredient was marketed in the 

United States prior to October 15, 1994, 

as well as how specifically or generally 

an ingredient on the list may be 

identified depending on the evidence 

presented for that ingredient. In 

addition, this discussion may also 

address whether certain botanical 

preparations can be accepted as ‘‘old’’ if 

the plant is demonstrated to be ‘‘old,’’ 

and whether certain classes of 

ingredients can be considered ‘‘old’’ 

based on common documentation. 

During the open comment period 

following this first panel, we will 

specifically invite comment about 

whether there are any considerations 

specific to certain classes or types of 

ingredients that should be taken into 

account as we develop the list. 

The second panel will discuss issues 

related to the process that should be 

used to develop the list. This includes, 

but is not limited to, the processes for 

nominating and reviewing ingredients; 

whether an outside panel should be 

convened and, if so, the composition 

and role of that panel; how information 

that is claimed to be confidential should 

be treated; and what the ultimate list 

should look like. 

The topics discussed at the public 

meeting, both during the panel 

discussions and during open public 

comment periods, as well as written 

comments submitted after the meeting, 

will help us determine how to develop 

this list of old dietary ingredients. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following Web 

site: https://www.fda.gov/Food/ 

NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm. Please provide complete 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
42100 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by midnight Eastern Time on 

September 25, 2017. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact 

Juanita Yates (see FOR FURTHER

INFORMATION CONTACT) no later than 

September 18, 2017. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations and request time for a 

joint presentation. All requests to make 

oral presentations must be received by 

September 18, 2017. We will determine 

the amount of time allotted to each 

presenter and will select and notify 

participants by September 25, 2017. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. Please visit the following 

Web site to register: https://

www.fda.gov/Food/NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm. 

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. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

Internet at https://www.fda.gov/Food/ 

DietarySupplements/default.htm. 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18812 Filed 9–5–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Food and Drug Administration, Center 

for Drug Evaluation and Research Rare 

Diseases Public Workshop: Strategies, 

Tools, and Best Practices for Effective 

Advocacy in Rare Diseases Drug 

Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for Drug 

Evaluation and Research (CDER), is 

sponsoring a public workshop entitled 

‘‘CDER Rare Diseases Public Workshop: 

Strategies, Tools, and Best Practices for 

Effective Advocacy in Rare Diseases 

Drug Development.’’ This public 

workshop builds upon previous CDER 

patient advocacy public workshops and 

is primarily for the rare disease 

community to help them effectively 

understand what FDA needs to enhance 

drug development. This effort is 

consistent with FDA’s efforts to support 

the integration of patient experience in 

drug development programs, including 

through implementation of the ‘‘PatientFocused Drug Development’’ provisions 

of the 21st Century Cures Act (Cures 

Act). This public workshop will include 

case studies demonstrating the 

beneficial overlap of effective advocacy 

techniques and FDA regulations in rare 

disease drug development. 

DATES: The public workshop will be 

held on October 30, 2017, from 8 a.m. 

to 5 p.m. 

ADDRESSES: The public workshop will 

be held at FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

(the Great Room), Silver Spring, MD 

20993. Entrance for the public 

workshop participants (non-FDA 

employees) is through Building 1 where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Francis Kalush, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–5429, PASERARE-DISEASES@fda.hhs.gov 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public workshop entitled 

‘‘CDER Rare Diseases Public Workshop: 

Strategies, Tools, and Best Practices for 

Effective Advocacy in Rare Diseases 

Drug Development.’’ The purpose of the 

public workshop, consistent with FDA’s 

broad effort to more comprehensively 

include patients’ perspectives and 

experiences with a disease or condition 

in the drug development process, 

including through implementation of 

the ‘‘Patient-Focused Drug 

Development’’ provisions of the Cures 

Act, is to aid in bridging the gap 

between rare disease patients’ stories 

and data needed to support drug 

development. This public workshop 

will include presentations on strategies, 

tools, and best practices on key aspects 

of rare diseases drug development and 

engaging with FDA. There will be an 

opportunity for questions and answers 

following each presentation. 

Registration: There is no registration 

fee to attend the public workshop. Early 

registration is recommended because 

seating is limited, and registration will 

be on a first-come, first-served basis. 

There will be no onsite registration. 

Persons interested in attending this 

public workshop must register online at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm565398.htm before September 30, 

2017. For those without internet access, 

please contact Francis Kalush (see FOR

FURTHER INFORMATION CONTACT) to 

register. 

If you need special accommodations 

due to a disability, please contact 

Francis Kalush (see FOR FURTHER

INFORMATION CONTACT) no later than 

October 23, 2017. 

Transcripts: A transcript of the public 

workshop will be available for review at 

the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, and on the internet at 

https://www.regulations.gov 

approximately 30 days after the public 

workshop. Transcripts will also be 

available in either hard copy or on CD– 

ROM, after submission of a Freedom of 

Information request. The Freedom of 

Information office address is available 

on the Agency’s Web site at https://

www.fda.gov. 

Dated: August 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18810 Filed 9–5–17; 8:45 am] 

BILLING CODE 4164–01–P 


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