47750 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 

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copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed 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access to the draft guidance document.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: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Rm. 1670, Silver 

Spring, MD 20993, 240–402–7930, 

elizabeth.giaquinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Determining Whether to Submit an 

ANDA or a 505(b)(2) Application.’’ This 

guidance is intended to serve as a 

foundational guidance to assist 

applicants in determining which one of 

the abbreviated approval pathways 

under the FD&C Act is appropriate for 

the submission of a marketing 

application to FDA. This guidance 

highlights criteria for submitting 

applications under the abbreviated 

approval pathways described in section 

505(j) and 505(b)(2) of the FD&C Act (21 

U.S.C. 355(j) and 21 U.S.C. 355(b)(2), 

respectively), identifies considerations 

to help potential applicants determine 

whether an application would be more 

appropriately submitted under section 

505(j) or under section 505(b)(2) of the 

FD&C Act, and provides direction to 

potential applicants on requesting 

assistance from FDA in making this 

determination. 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) (the Hatch-Waxman 

Amendments) added section 505(b)(2) 

and 505(j) of the FD&C Act, which 

describe abbreviated approval pathways 

for drug products regulated by the 

Agency under the FD&C Act. The HatchWaxman Amendments reflect 

Congress’s efforts to balance the need to 

‘‘make available more low cost generic 

drugs by establishing a generic drug 

approval procedure’’ with new 

incentives for drug development in the 

form of exclusivities and patent term 

extensions. With the passage of the 

Hatch-Waxman Amendments, the FD&C 

Act describes different routes for 

obtaining approval of two broad 

categories of drug applications: New 

drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs). 

This guidance focuses on those 

applications that can be submitted as 

ANDAs under section 505(j) of the 

FD&C Act, petitioned ANDAs under 

section 505(j)(2)(C) of the FD&C Act, or 

NDAs under section 505(b)(2) of the 

FD&C Act. This guidance does not 

discuss stand-alone NDAs. 

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 factors for applicants to consider 

when determining whether to submit an 

ANDA or a 505(b)(2) application. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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). The collections 

of information in 21 CFR 314.94 have 

been approved under OMB control 

number 0910–0001. The collection of 

information for controlled 

correspondence and pre-ANDA meeting 

requests has been approved under OMB 

control number 0910–0797. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http://

www.regulations.gov. 

Dated October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22196 Filed 10–12–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5991] 

Agricultural Biotechnology Education 

and Outreach Initiative; Public 

Meetings; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meetings; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the following public 

meetings entitled ‘‘Agricultural 

Biotechnology Education and Outreach 

Initiative.’’ The purpose of the public 

meetings is to provide the public with 

an opportunity to share information, 

experiences, and suggestions to help 

inform the development of this 

education and outreach initiative. 

DATES: The public meetings will be held 

on November 7, 2017, in Charlotte, 

North Carolina, and on November 14, 

2017, in San Francisco, California. 

Submit either electronic or written 

comments by November 17, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public meetings will be 

held at: 

• The Omni Charlotte, 132 East Trade 

St., Charlotte, NC 28202 on November 7, 

2017, and 

• The San Francisco Marriott 

Marquis, 780 Mission St., San 

Francisco, CA 94103 on November 14, 

2017. 

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 November 17, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 17, 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47751 

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–5991 for ‘‘Agricultural 

Biotechnology Education and Outreach 

Initiative; Public Meetings; 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.’’ 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: For 

questions regarding registration to 

attend a meeting: Simone Katz, Strategic 

Results, 101 Lakeforest Blvd., Suite 390, 

Gaithersburg, MD 20877, 240–449–8427, 

simone.katz@strategicresults.com. For 

all other questions: Juanita Yates, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–1731, Juanita.yates@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Consolidated Appropriations Act, 

2017 (Pub. L. 115–31) stipulates that the 

Commissioner of Food and Drugs, in 

coordination with the Secretary of 

Agriculture, will use appropriated funds 

to provide consumer outreach and 

education regarding agricultural 

biotechnology and biotechnologyderived food products and animal feed, 

including through publication and 

distribution of science-based 

educational information on the 

environmental, nutritional, food safety, 

economic, and humanitarian impacts of 

such biotechnology. 

FDA is responsible for promoting and 

protecting the public health, including 

by ensuring that the nation’s food 

supply is safe and nutritious. FDA 

provides information and outreach to a 

variety of audiences along with 

extensive, hands-on food safety and 

nutrition education programs for 

educators, health professionals, and 

consumers. Educational materials are 

targeted to consumers in general, as well 

as to specific groups such as children/ 

youth, older Americans, underserved 

populations, individuals with weakened 

immune systems (related to food safety), 

pregnant women, and other 

subpopulations. 

To further our public health mission, 

we develop food safety and nutrition 

outreach initiatives in conjunction with 

non-Federal organizations and 

individuals, including teachers, 

community leaders, health educators, 

animal owners, and private and public 

health professionals, to increase 

awareness of and provide education on 

food safety and nutrition. 

In developing and implementing the 

Agricultural Biotechnology Education 

and Outreach Initiative, FDA will 

coordinate with the U.S. Department of 

Agriculture (USDA). We also will 

collaborate with other U.S. Federal 

Government Agencies, and public and 

private organizations as needed. These 

interactions will help us to develop a 

comprehensive and thorough framework 

for consumer education and awareness 

of the environmental, nutritional, food 

safety, economic, and humanitarian 

impacts of agricultural biotechnology. 

We believe public comment will be 

helpful to inform the development of 

this education and outreach initiative. 

II. Topics for Discussion at the Public 

Meetings 

FDA is holding two public meetings, 

one in North Carolina and one in 

California, to provide the public with an 

opportunity to provide comments 

related to FDA’s Agricultural 

Biotechnology Education and Outreach 

Initiative. We invite the public to share 

information, experiences, and 

suggestions that can help inform the 

development of the education and 

outreach initiative. We invite interested 

persons, including those participating in 

the public meetings, to respond to the 

following questions specifically 

regarding agricultural biotechnology 

and biotechnology-derived food 

products and animal feed: 

1. What are the specific topics, 

questions, or other information that 

consumers would find most useful, and 

why? 

2. Currently, how and from where do 

consumers most often receive 

information on this subject? 

3. How can FDA (in coordination with 

USDA) best reach consumers with 

science-based educational information 

on this subject? 

The comments received will help 

FDA identify education goals, 

messaging, and dissemination strategies 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47752 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 

for FDA’s Agricultural Biotechnology 

Education and Outreach Initiative. 

III. Participating in the Public Meeting 

Registration: To register for a public 

meeting, please include your name, 

title, firm name, address, and phone and 

fax numbers in your registration 

information and send to: Simone Katz, 

Strategic Results, 101 Lakeforest Blvd., 

Suite 390, Gaithersburg, MD 20877, 

240–449–8427, Fax: 240–641–9042, 

email: simone.katz@

strategicresults.com. You can register for 

one or both meetings. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by October 30, 2017, for the 

Charlotte, NC, meeting and must register 

by November 6, 2017, for the San 

Francisco, CA, meeting. 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 

Simone Katz, Strategic Results, 101 

Lakeforest Blvd., Suite 390, 

Gaithersburg, MD 20877, 240–449–8427, 

Fax: 240–641–9042, email: 

simone.katz@strategicresults.com no 

later than October 20, 2017, for the 

Charlotte, NC, meeting and no later than 

October 27, 2017, for the San Francisco, 

CA, meeting. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session or participate 

in a specific 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, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

October 24, 2017, for the meeting in 

Charlotte, NC, and by November 1, 

2017, for the meeting in San Francisco, 

CA. All requests to make oral 

presentations must be received by 

October 20, 2017, for the meeting in 

Charlotte, NC, and by October 27, 2017, 

for the meeting in San Francisco, CA. 

Streaming Webcast of the Public 

Meeting: Each public meeting will also 

be webcast. Individuals who wish to 

participate by webcast are asked to 

preregister at: https://www.fda.gov/ 

Food/NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, 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 each 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/ 

NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm. 

Other Issues for Consideration: A 

summary of key information on 

participating in a meeting follows: 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING

Date Address Preregister Electronic address 

Request to 

make an oral 

presentation 

Special 

accommodations 

Submit either electronic or 

written comments 

November 7, 

2017, from 8:30 

a.m. to 1 p.m. 

EST.

Omni Charlotte 

Hotel, 132 E 

Trade St., 

Charlotte, NC 

28202.

October 30, 

2017: Closing 

date for registration.

Please preregister at https://

www.fda.gov/Food/ 

NewsEvents/ 

WorkshopsMeetingsConferences/default.htm.

October 20, 

2017.

October 20, 

2017: Closing 

date to request special 

accommodations due to a 

disability.

Submit Comments by November 

17, 2017, to: https://

www.regulations.gov, or Dockets Management Staff (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 

20852. 

November 14, 

2017, from 8:30 

a.m. to 1 p.m. 

PST.

San Francisco 

Marriott Marquis, 780 Mission St., San 

Francisco, CA 

94103.

November 6, 

2017: Closing 

date for registration.

Please preregister at https://

www.fda.gov/Food/ 

NewsEvents/ 

WorkshopsMeetingsConferences/default.htm.

October 27, 

2017.

October 27, 

2017: closing 

date to request special 

accommodations due to a 

disability.

Same as above. 

You may also register via email, mail, 

or fax. Please include your name, title, 

firm name, address, and phone and Fax 

numbers in your registration 

information and send to: Simone Katz, 

Strategic Results, 101 Lakeforest Blvd., 

Suite 390, Gaithersburg, MD 20877, 

240–449–8427, Fax: 240–641–9042, 

email: simone.katz@

strategicresults.com. 

Individuals who wish to participate 

by webcast are asked to preregister at: 

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

WorkshopsMeetingsConferences/ 

default.htm. 

Dated: October 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22172 Filed 10–12–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5953] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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