50142 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

1FDA currently has OMB approval for 

submission of postmarketing safety reports under 

parts 310, 314, and 600. The information collection 

for parts 310 and 314 is approved under OMB 

control numbers 0910–0291 and 0910–0230. The 

information collection for part 600 is approved 

under OMB control numbers 0910–0291 and 0910– 

0308. Submissions required by section 760 of the 

FD&C Act have been approved under OMB control 

number 0910–0636. 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Postmarketing Safety Reports for 

Human Drug and Biological Products: 

Waivers From Electronic Submission 

Requirements—OMB Control Number 

0910–0770—Extension 

This information collection supports 

FDA regulations. In the Federal Register 

of June 10, 2014 (79 FR 33072), FDA 

published a final rule entitled 

‘‘Postmarketing Safety Reports for 

Human Drug and Biological Products: 

Electronic Submission Requirements.’’ 

The final rule amended FDA’s 

postmarketing safety reporting 

regulations for human drug and 

biological products under 21 CFR parts 

310, 314, and 600 and added part 329 

to require that persons subject to 

mandatory reporting requirements 

submit safety reports in an electronic 

format that FDA can process, review, 

and archive. Specifically, this includes: 

• manufacturers; packers; 

distributors; applicants with approved 

new drug applications, abbreviated new 

drug applications, and biologics 

licensing applications (BLAs); and those 

that market prescription drugs for 

human use without an approved 

application must submit postmarketing 

safety reports to the Agency (§§ 310.305, 

314.80, 314.98, and 600.80); 

• manufacturers, packers, or 

distributors whose name appears on the 

label of nonprescription human drug 

products marketed without an approved 

application must report serious adverse 

events associated with their products 

(section 760 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 379aa)); and 

• applicants with approved BLAs 

must submit biological lot distribution 

reports to the Agency (§ 600.81). 

Under §§ 310.305(e)(2), 314.80(g)(2), 

329.100(c)(2), 600.80(h)(2), and 

600.81(b)(2), those who are subject to 

these postmarketing safety reporting 

requirements may request a waiver from 

the electronic format requirement. 

While FDA currently has OMB approval 

for the collection of postmarketing 

safety reports,1 this information 

collection supports respondents seeking 

waivers from submitting those reports in 

electronic format as required by the 

regulations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

310.305(e)(2) ....................................................................... 1 1 1 1 1 

314.80(g)(2) ......................................................................... 5 1 5 1 5 

329.100(c)(2) ........................................................................ 1 1 1 1 1 

600.80(h)(2) ......................................................................... 5 1 5 1 5 

600.81(b)(2) ......................................................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 13 

1There are no capital or operating and maintenance costs associated with this collection of information. 

In table 1 of this document, we 

estimate the burden associated with the 

submission of waiver requests for 

postmarketing safety reports in 

electronic format under §§ 310.305(e)(2), 

314.80(g)(2), 329.100(c)(2), 600.80(h)(2), 

and 600.81(b)(2). We expect few waiver 

requests. We estimate that 

approximately one manufacturer will 

request a waiver annually under 

§§ 310.305(e)(2), 329.100(c)(2), and 

600.81(b)(2), and approximately five 

manufacturers will request a waiver 

annually under §§ 314.80(g)(2) and 

600.80(h)(2). We estimate that each 

waiver request will take approximately 

1 hour to prepare and submit. 

Dated: October 24, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23518 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0880] 

Assessing User Fees Under the 

Generic Drug User Fee Amendments of 

2017; Draft 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 draft 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50143 

guidance for industry entitled 

‘‘Assessing User Fees Under the Generic 

Drug User Fee Amendments of 2017.’’ 

This draft guidance provides 

stakeholders information regarding the 

implementation of the Generic Drug 

User Fee Amendments of 2017 (GDUFA 

II) and policies and procedures 

surrounding its application. 

DATES: Submit either electronic or 

written comments on the guidance 

December 29, 2017 to ensure that the 

Agency considers your comment on this 

draft 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– 

2012–D–0880 for ‘‘Assessing User Fees 

Under the Generic Drug User Fee 

Amendments of 2017.’’ 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 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: 

Mehrban Iranshad, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Rm. 4145, Silver 

Spring, MD 20993, 301–796–7900, 

CDERCollections@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Assessing User Fees Under the Generic 

Drug User Fee Amendments of 2017.’’ 

GDUFA II (Pub. L. 115–52, Title III) was 

signed into law by the President on 

August 18, 2017. GDUFA II continues 

FDA’s and industry’s goal to improve 

the public’s access to safe and effective 

generic drugs and to improve upon the 

predictability of the review process. 

GDUFA II extends FDA’s authority to 

collect user fees from fiscal year (FY) 

2018 to FY 2022 and introduces a 

number of technical revisions that affect 

what fees are collected and how some 

fees are collected. GDUFA II authorizes 

fees for abbreviated new drug 

applications (ANDAs), drug master files 

(DMFs), annual facility fees, a one-time 

fee for original ANDAs pending with 

FDA on October 1, 2012 (backlog fees), 

and the Generic Drug Applicant 

Program Fee (GDUFA Program Fee). 

The draft guidance announced in this 

notice addresses changes in user fee 

assessments from GDUFA I, user fees 

incurred by industry under GDUFA II, 

payment procedures, reconsideration 

and appeals, and other additional 

information to assist industry in 

complying with GDUFA II. FDA will 

issue separate guidance documents 

regarding GDUFA II non-user fee 

requirements and processes. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance, when finalized, will 

represent the Agency’s current thinking 

on ‘‘Assessing User Fees Under the 

Generic Drug User Fee Amendments of 

2017.’’ 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 guidance contains information 

collection provisions 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– 


sradovich on DSK3GMQ082PROD with NOTICES
50144 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

3520). The guidance refers to collections 

of information for filling out and 

submitting Form FDA 3913 (User Fee 

Payment Refund Request), previously 

approved under OMB control number 

0910–0805, and Form FDA 3914 (User 

Fee Payment Transfer Request), 

previously approved under OMB 

control number 0910–0805. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: October 25, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23526 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0689] 

De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation); Guidance for Industry 

and Food and Drug Administration 

Staff; 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 the 

guidance entitled ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation).’’ The 

purpose of this document is to provide 

guidance on the process for the 

submission and review of a De Novo 

classification request (hereafter a ‘‘De 

Novo request’’) under the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

also known as the De Novo 

classification process. FDA is issuing 

this guidance to also provide updated 

recommendations for interactions with 

FDA related to the De Novo 

classification process, including what 

information to submit when seeking a 

path to market via the De Novo 

classification process. This guidance 

replaces ‘‘New Section 513(f)(2)— 

Evaluation of Automatic Class III 

Designation, Guidance for Industry and 

CDRH Staff,’’ dated February 19, 1998. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 30, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2011–D–0689 for ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation); 

Guidance for Industry and Food and 

Drug Administration Staff; 

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 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002 or the 

Office of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 


sradovich on DSK3GMQ082PROD with NOTICES