45594 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

2017–D–2165 for ‘‘Oncology 

Pharmaceuticals: Reproductive Toxicity 

Testing and Labeling Recommendations; 

Draft Guidance for Industry; 

Availability.’’ 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 

Division of Dockets Management 

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 Division of Dockets 

Management. 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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

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copies of the draft guidance to the 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: John 

Leighton, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2204, Silver Spring, 

MD 20993–0002, 301–796–0750; or 

Haleh Saber, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2117, Silver Spring, 

MD 20993–0002, 301–796–0750. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Oncology Pharmaceuticals: 

Reproductive Toxicity Testing and 

Labeling Recommendations.’’ This 

guidance presents FDA’s current 

approach to assessing potential risks to 

embryo-fetal development associated 

with oncology pharmaceutical use in 

male and female patients. The term 

pharmaceutical in this guidance refers 

to small molecules, therapeutic 

proteins, antibodies, and related 

products such as conjugated products. 

The guidance describes when embryofetal developmental studies for oncology 

pharmaceuticals may be warranted for 

different types of pharmaceuticals, such 

as cytotoxic, biological, and conjugated 

pharmaceuticals, or pharmaceuticals 

used in combinations. The guidance 

also discusses other aspects of a 

nonclinical reproductive toxicity 

evaluation, such as fertility and pre- and 

postnatal evaluation. The guidance 

addresses the need for a reproductive 

toxicity evaluation when 

pharmaceuticals are used in specific 

populations (e.g., pediatric, males-only, 

or postmenopausal women). 

Although current regulatory 

guidances exist regarding the need to 

assess the embryo-fetal developmental 

toxicity potential of pharmaceuticals 

and the overall design of the studies, 

this guidance provides additional 

recommendations on specific types of 

products and for specific populations, 

which are not covered under other 

guidances. In addition, this guidance 

provides recommendations on the use of 

contraception and the duration of its use 

to minimize the potential risks 

associated with the use of oncology 

pharmaceuticals. 

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 reproductive toxicity testing and 

labeling recommendations for oncology 

pharmaceuticals. 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 is not a 

significant regulatory action subject to 

Executive Order 12866. 

II. The Paperwork Reduction Act of 

1995 

This 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). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. The collections of 

information in 21 CFR 201.56, 201.57, 

and the final rule ‘‘Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products; 

Requirements for Pregnancy and 

Lactation Labeling’’ have been approved 

under OMB control numbers 0910–0572 

and 0910–0624. 

III. 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: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20906 Filed 9–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4644] 

Advancement of Emerging Technology 

Applications for Pharmaceutical 

Innovation and Modernization; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

guidance for industry entitled 

‘‘Advancement of Emerging Technology 

Applications for Pharmaceutical 

Innovation and Modernization.’’ This 

guidance finalizes the draft guidance 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45595 

issued December 23, 2015, which 

provides recommendations to 

pharmaceutical companies interested in 

participating in a program involving the 

submission of emerging manufacturing 

technology. The program is open to 

companies that intend to include the 

technology as part of a regulatory 

submission including an investigational 

new drug application (IND), original or 

supplemental new drug application 

(NDA), abbreviated new drug 

application (ANDA) or biologic license 

application (BLA), or applicationassociated Drug Master File (DMF) 

reviewed by the Center for Drug 

Evaluation and Research (CDER), and 

where that technology meets other 

criteria described in this guidance. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: You may submit comments 

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– 

2015–D–4644 for ‘‘Advancement of 

Emerging Technology Applications for 

Pharmaceutical Innovation and 

Modernization.’’ 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. 

Submit written requests for single 

copies of this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: Sau 

L. Lee, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, Bldg. 22, Rm. 2128, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 240–506–9136; 

or for further information or to submit 

requests to participate in the program, 

please use CDER-ETT@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Advancement of Emerging Technology 

Applications for Pharmaceutical 

Innovation and Modernization.’’ FDA is 

committed to supporting and enabling 

pharmaceutical innovation and 

modernization as part of the Agency’s 

mission to protect and promote the 

public health. While the 

implementation of emerging technology 

is critical to advancing product design, 

modernizing pharmaceutical 

manufacturing, and improving quality, 

FDA also recognizes that the adoption of 

innovative approaches may represent 

challenges to industry and the Agency. 

Issues in pharmaceutical 

manufacturing have the potential to 

significantly impact patient care as 

failures in quality may result in product 

recalls and harm to patients. 

Additionally, product failures or 

facility, equipment, or manufacturing 

problems are a major factor leading to 

disruptions in drug supply. 

Modernizing manufacturing technology 

may lead to a more robust 

manufacturing process with fewer 

interruptions in production, fewer 

product failures (before or after 

distribution), and greater assurance that 

the drug products manufactured in any 

given period of time will provide the 

expected clinical performance. 

Encouraging development of emerging 

technology may lead to pharmaceutical 

innovation and modernization, such as 

a more robust drug product design and 

improved manufacturing with better 

process control, thereby leading to 

improved product quality and 

availability throughout a product’s 

lifecycle. 

In this program, pharmaceutical 

companies can, prior to the regulatory 

submission, submit questions and 

proposals about the use of specific 

emerging technology to a group within 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
45596 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

the FDA Emerging Technology Team 

(ETT), which includes relevant 

representation from all FDA 

pharmaceutical quality functions. The 

ETT works in partnership with relevant 

pharmaceutical quality offices and 

assumes a leadership or co-leadership 

role for the cross-functional quality 

assessment team (including review and 

on-site facility evaluation or inspection) 

for submissions involving emerging 

technology. 

This guidance finalizes the draft 

guidance issued December 23, 2015 (80 

FR 79907). It provides further 

clarification on the criteria that the 

proposed technology needs to meet for 

its acceptance into the Emerging 

Technology Program. It also clarifies 

types of novel technology (e.g., product 

technology, manufacturing process, and 

control strategy) that can be covered by 

the program. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on advancement of 

emerging technology applications for 

pharmaceutical innovation and 

modernization. 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. 

II. The Paperwork Reduction Act of 

1995 

This 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 information to be included 

in a meeting request for a product 

submitted in an IND, BLA, or NDA is 

approved by OMB control number 

0910–0429 (‘‘Guidance for Industry on 

Formal Meetings Between the FDA and 

Sponsors or Applicants’’). Information 

to be included in a meeting request for 

a product submitted in an ANDA is 

approved by OMB control number 

0910–0797 (‘‘Guidance on Controlled 

Correspondence Related to Generic Drug 

Development’’). The submission of INDs 

under 21 CFR 312.23 is approved by 

OMB control number 0910–0014; the 

submission of BLAs under 21 CFR 601.2 

and 601.12 is approved by OMB control 

number 0910–0338; and the submission 

of NDAs and ANDAs under 21 CFR 

314.50, 314.70, 314.71, 314.94, and 

314.97 is approved by OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or https://www.regulations.

gov. 

Dated: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20861 Filed 9–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5315] 

Antimicrobial Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Antimicrobial Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

November 16, 2017, from 8:30 a.m. to 4 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–5315. 

The docket will close on November 15, 

2017. Submit either electronic or 

written comments on this public 

meeting by November 15, 2017. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before November 15, 2017. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

November 15, 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. 

Comments received on or before 

November 1, 2017, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. 

You may submit comments 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–N–5315 for ‘‘Antimicrobial Drugs 


asabaliauskas on DSKBBXCHB2PROD with NOTICES