Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50141 

Institutes of Health/National Library of 

Medicine or a similar source. When 

providing this information, please 

provide weblinks to where this 

information is publicly available. This 

information may assist in FDA’s 

determination of which SDOs may 

fulfill the statutory requirements. 

Dated: October 25, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23519 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–2008–N–0334] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarketing 

Safety Reports for Human Drug and 

Biological Products: Electronic 

Submission Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the requirements 

for electronic submission of 

postmarketing safety reports for human 

drug and biological products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 29, 2017. 

ADDRESSES: 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 29, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 29, 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– 

2008–N–0334 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Postmarketing Safety Reports for Human 

Drug and Biological Products: Electronic 

Submission Requirements.’’ 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.’’ 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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 


sradovich on DSK3GMQ082PROD with NOTICES
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