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access to the draft guidance document.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a draft guidance for industry entitled 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Specifically, this draft guidance, 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This draft guidance is one in a series 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 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44427 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On November 7, 2017, the 

committee will meet in an open session 

to discuss and make recommendations 

on the clinical development plan for 

Pfizer’s investigational Staphylococcus 

aureus vaccine intended for pre-surgical 

prophylaxis in elective orthopedic 

surgical populations. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 31, 2017. 

Oral presentations from the public will 

be scheduled between approximately 

1:15 p.m. and 2:15 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 23, 2017. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 24, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Serina HunterThomas at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20240 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–0016] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recordkeeping 

and Records Access Requirements for 

Food Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 0910–0560. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Recordkeeping and Records Access 

Requirements for Food Facilities—21 

CFR 1.337, 1.345, and 1.352 

OMB Control Number 0910–0560— 

Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 414 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 350c), which 

requires that persons who manufacture, 

process, pack, hold, receive, distribute, 

transport, or import food in the United 

States establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food. Sections 1.326 

through 1.363 of our regulations (21 

CFR 1.326 through 1.363) set forth the 

requirements for recordkeeping and 

records access. The requirement to 

establish and maintain records improves 

our ability to respond to, and further 

contain, threats of serious adverse 

health consequences or death to humans 

or animals from accidental or deliberate 

contamination of food. 

Information maintained under these 

regulations will help us identify and 

locate quickly contaminated or 

potentially contaminated food and 

inform the appropriate individuals and 

food facilities of specific terrorist 

threats. Our regulations require that 

records for non-transporters include the 

name and full contact information of 

sources, recipients, and transporters; an 

adequate description of the food, 

including the quantity and packaging; 

and the receipt and shipping dates 

(§§ 1.337 and 1.345). Required records 

for transporters include the names of 

consignor and consignee, points of 

origin and destination, date of 

shipment, number of packages, 

description of freight, route of 

movement and name of each carrier 

participating in the transportation, and 

transfer points through which shipment 

moved (§ 1.352). Existing records may