44424 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Maintenance of reportable food records under 

section 417(g) of the FD&C Act—mandatory reports.

1,200 1 1,200 0.25 (15 minutes) ........ 300 

Maintenance of reportable food records under 

section 417(g) of the FD&C Act—voluntary reports.

4 1 4 0.25 (15 minutes) ........ 1 

Total ................................................................ ........................ ........................ ........................ ..................................... 301 

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

Recordkeeping: As noted previously, 

section 417(g) of the FD&C Act requires 

that responsible persons maintain 

records related to reportable foods 

reports and notifications under section 

417 of the FD&C Act for a period of 2 

years. Based on past FDA experiences, 

we estimate that each mandatory report 

and its associated notifications will 

require 30 minutes of recordkeeping for 

the 2-year period, or 15 minutes per 

record per year. The annual 

recordkeeping burden for mandatory 

reportable food reports and their 

associated notifications is thus 

estimated to be 300 hours (1,200 × 0.25 

hours). 

We do not expect that records will 

always be kept in relation to voluntary 

reportable food reports. Therefore, we 

estimate that records will be kept for 

four voluntary reports we expect to 

receive annually. The recordkeeping 

burden associated with voluntary 

reports is thus estimated to be 1 hour 

annually (4 × 0.25 hours). The estimated 

total annual recordkeeping burden will 

be 301 hours annually (1,200 × 0.25 

hours) + (4 × 0.25 hours). This annual 

burden is shown in table 2. 

Dated: September 19, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–20283 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0019] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Customer/Partner 

Service Surveys 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 23, 

2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0360. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Customer/Partner Service Surveys 

OMB Control Number 0910–0360— 

Extension 

Under section 903 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393), FDA is authorized to conduct 

research and public information 

programs about regulated products and 

responsibilities of the Agency. 

Executive Order 12862, entitled, 

‘‘Setting Customer Service Standard,’’ 

directs Federal Agencies that ‘‘provide 

significant services directly to the 

public’’ to ‘‘survey customers to 

determine the kind and quality of 

services they want and their level of 

satisfaction with existing services.’’ FDA 

is seeking OMB clearance to conduct a 

series of surveys to implement 

Executive Order 12862. Participation in 

the surveys is voluntary. This request 

covers customer/partner service surveys 

of regulated entities, such as food 

processors; cosmetic drug, biologic and 

medical device manufacturers; 

consumers; and health professionals. 

The request also covers ‘‘partner’’ (State 

and local governments) customer 

service surveys. 

FDA will use the information from 

these surveys to identify strengths and 

weaknesses in service to customers/ 

partners and to make improvements. 

The surveys will measure timeliness, 

appropriateness and accuracy of 

information, and courtesy and problem 

resolution in the context of individual 

programs. 

FDA estimates conducting 15 

customer/partner service surveys per 

year, each requiring an average of 15 

minutes for review and completion. We 

estimate respondents to these surveys to 

be between 100 and 20,000 customers. 

Some of these surveys will be repeats of 

earlier surveys for purposes of 

monitoring customer/partner service 

and developing long-term data. 

In the Federal Register of June 7, 2017 

(82 FR 26497), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44425 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of survey Number of 

respondents 

Annual 

frequency per 

response 

Hours per 

response Total hours 

Mail, telephone, web-based ..................................................................... 55,000 1 .25 (15 minutes) .... 13,750 

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

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20246 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5525] 

Statistical Approaches To Evaluate 

Analytical Similarity; 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 

guidance for industry entitled 

‘‘Statistical Approaches to Evaluate 

Analytical Similarity.’’ This draft 

guidance, when finalized, will provide 

advice on the evaluation of analytical 

similarity to sponsors interested in 

developing biosimilar products. 

Specifically, this draft guidance 

describes the type of information a 

sponsor of a proposed biosimilar 

product should obtain about the 

structural/physicochemical and 

functional attributes of the reference 

product, how that information is used in 

the development of an analytical 

similarity assessment plan for the 

proposed biosimilar, and the statistical 

approaches recommended for evaluating 

analytical similarity. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 21, 2017 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–5525 for ‘‘Statistical 

Approaches to Evaluate Analytical 

Similarity; 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 

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, 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, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY