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Analytical Similarity; Draft Guidance 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Specifically, this draft guidance 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written comments on the draft guidance 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draft guidance before it begins work on 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

44426 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Scott N. Goldie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–2055, or the Office of 

Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 800–835–4709 or 240– 

402–8010. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 for 

licensure under section 351(k) of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 262(k)). This evaluation is 

performed to support a demonstration 

that the proposed biosimilar is highly 

similar to a reference product licensed 

under section 351(a) of the PHS Act. 

Specifically, this draft guidance, 

when finalized, will describe the type of 

information that the 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. 

The Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) 

created an abbreviated licensure 

pathway under section 351(k) of the 

PHS Act for biological products shown 

to be biosimilar to or interchangeable 

with a U.S.-licensed biological reference 

product (see sections 7001 through 7003 

of Pub. L. 111–148). As described in 

section 351(k)(2)(A)(i)(I)(aa) of the PHS 

Act, an application for a proposed 

biosimilar product must include 

information demonstrating biosimilarity 

based on data derived from, among 

other things, ‘‘analytical studies that 

demonstrate that the biological product 

is highly similar to the reference 

product notwithstanding minor 

differences in clinically inactive 

components.’’ 

This draft guidance is one in a series 

of guidance documents intended to 

implement the BPCI Act. It serves as a 

companion document to the guidance 

for industry entitled ‘‘Quality 

Considerations in Demonstrating 

Biosimilarity of a Therapeutic Protein 

Product to a Reference Product’’ (April 

30, 2015, 80 FR 24257). The Quality 

Considerations guidance describes the 

Agency’s recommendations to sponsors 

on the scientific and technical 

information, including the analytical 

studies to support a demonstration that 

a proposed biosimilar is highly similar 

to the U.S.-licensed reference product, 

for the chemistry, manufacturing, and 

controls section of a marketing 

application for a proposed biosimilar 

product. 

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 statistical approaches to evaluating 

analytical similarity. 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 draft 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). This includes 

information collections related to: (1) 

The submission of an investigational 

new drug application, which is covered 

under 21 CFR part 312 and approved 

under OMB control number 0910–0014; 

(2) the submission of a new drug 

application, which is covered under 21 

CFR 314.50 and approved under OMB 

control number 0910–0001; (3) the 

submission of a biologics license 

application under section 351(k) of the 

PHS Act, which is covered under 21 

CFR part 601 and approved under OMB 

control number 0910–0719; and (4) 

meetings between FDA and applicants 

or sponsors of a biologics license 

application under section 351(k) of the 

PHS Act, which is approved under OMB 

control number 0910–0802. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or https://

www.regulations.gov. 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20263 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–N–0001] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC). The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. 

DATES: The meeting will be held on 

November 7, 2017, from 8:30 a.m. to 5 

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. 

For those unable to attend in person, the 

meeting will also be webcast and will be 

available at the following link: https:// 

collaboration.fda.gov/cbervrbpac2017. 

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/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6307C, Silver Spring, MD 20993–0002, 

240–402–5771, serina.hunter-thomas@

fda.hhs.gov; or Rosanna Harvey, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6336, Silver Spring, MD 20993–0002, 

240–402–8072, rosanna.harvey@

fda.hhs.gov; or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute