1618 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5974] 

Determining Whether To Submit an 

Abbreviated New Drug Application or 

505(b)(2) Application; Draft Guidance 

for Industry; Availability; Reopening of 

the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; reopening 

of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for the 

notice of availability, published in the 

Federal Register of October 13, 2017. In 

that document, FDA requested 

comments on the draft guidance for 

industry entitled ‘‘Determining Whether 

to Submit an ANDA or 505(b)(2) 

Application.’’ The Agency is taking this 

action 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 notice of availability 

published October 13, 2017 (82 FR 

47749). Submit either electronic or 

written comments on the draft guidance 

by February 12, 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draft guidance before it begins work on 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– 

2017–D–5974 for ‘‘Determining Whether 

to Submit an ANDA or 505(b)(2) 

Application; Draft Guidance for 

Industry.’’ 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 

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, Office of 

Generic Drugs, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1670, 

Silver Spring, MD 20993–0002, 240– 

402–7930. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 13, 

2017, FDA published a notice of 

availability with a 60-day comment 

period to request comments on the draft 

guidance for industry entitled 

‘‘Determining Whether to Submit an 

ANDA or 505(b)(2) Application.’’ 

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 which one of the 

abbreviated approval pathways under 

the Federal Food, Drug, and Cosmetic 

Act is appropriate for the submission of 

a marketing application to FDA. 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. 

The Agency has received a request for 

a 30-day extension of the comment 

period for the draft guidance. The 

request conveyed concern that the 

requestor did not have sufficient time to 

develop a meaningful or thoughtful 

response to the draft guidance. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 1619 

FDA has considered the request and 

is reopening the comment period for the 

draft guidance for 30 days, until 

February 12, 2018. The Agency believes 

that a 30-day reopening of the comment 

period allows adequate time for 

interested persons to submit comments 

to ensure that the Agency can consider 

the comments on this draft guidance 

before it begins work on the final 

version of the guidance. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: January 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00405 Filed 1–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6380] 

Clarification of Orphan Designation of 

Drugs and Biologics for Pediatric 

Subpopulations of Common Diseases; 

Draft Guidance for Industry; 

Availability; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

extending the comment period for the 

notice of availability that appeared in 

the Federal Register of December 20, 

2017. In the notice of availability, FDA 

requested comments on the draft 

guidance for industry entitled 

‘‘Clarification of Orphan Designation of 

Drugs and Biologics for Pediatric 

Subpopulations of Common Diseases.’’ 

The Agency is taking this action in 

response to public interest in the draft 

guidance and to allow interested 

persons additional time to submit 

comments. 

DATES: FDA is extending the comment 

period on the notice of availability 

published December 20, 2017 (82 FR 

60402). Submit either electronic or 

written comments on the draft guidance 

by February 18, 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– 

2017–D–6380 for ‘‘Clarification of 

Orphan Designation of Drugs and 

Biologics for Pediatric Subpopulations 

of Common Diseases.’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Friedman, Office of Orphan 

Products Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5295, Silver Spring, 

MD 20993, 301–796–8660. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 20, 2017, 

FDA published a notice of availability 

with a 30-day comment period to 

request comments on the draft guidance 

for industry entitled ‘‘Clarification of 

Orphan Designation of Drugs and 

Biologics for Pediatric Subpopulations 

of Common Diseases.’’ 

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 orphan designation of drugs and 

biologics for pediatric subpopulations of 

common diseases. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 


sradovich on DSK3GMQ082PROD with NOTICES