Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61495 

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. 

Medical Devices: Recommended 

Glossary and Educational Outreach to 

Support Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use 

(OMB Control Number 0910–0553)— 

Extension 

Section 502 of the Federal Food, Drug 

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

U.S.C. 352), among other things, 

establishes requirements for the label or 

labeling of a medical device so that it is 

not misbranded. Section 351 of the 

Public Health Service Act (the PHS Act) 

(42 U.S.C. 262) establishes requirements 

that manufacturers of biological 

products must submit a license 

application for FDA review and 

approval prior to marketing a biological 

product for introduction into interstate 

commerce. 

In the Federal Register of November 

30, 2004 (69 FR 69606), FDA published 

a notice of availability of the guidance 

entitled ‘‘Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use.’’ 

The guidance document provides 

guidance for the voluntary use of 

selected symbols in place of text in 

labeling. It provides the labeling 

guidance required for: (1) In vitro 

diagnostic devices (IVDs), intended for 

professional use under 21 CFR 809.10, 

FDA’s labeling requirements for IVDs 

and (2) FDA’s labeling requirements for 

biologics, including IVDs under 21 CFR 

parts 610 and 660. Under section 502(c) 

of the FD&C Act, a drug or device is 

misbranded, ‘‘* * *If any word, 

statement, or other information required 

by or under authority of this Act to 

appear on the label or labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ 

The guidance document recommends 

that a glossary of terms accompany each 

IVD to define the symbols used on that 

device’s labels and/or labeling. 

Furthermore, the guidance recommends 

an educational outreach effort to 

enhance the understanding of newly 

introduced symbols. Both the glossary 

and educational outreach information 

will help to ensure that IVD users will 

have enough general familiarity with the 

symbols used, as well as provide a quick 

reference for available materials, thereby 

further ensuring that such labeling 

satisfies the labeling requirements under 

section 502(c) of the FD&C Act and 

section 351 of the PHS Act. 

The likely respondents for this 

collection of information are IVD 

manufacturers who plan to use the 

selected symbols in place of text on the 

labels and/or labeling of their IVDs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Section 502 of the FD&C 

Act/Section 351 of the PHS 

Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Glossary 689 1 689 4 2,756 

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

The glossary activity is inclusive of 

both domestic and foreign IVD 

manufacturers. FDA receives 

submissions from approximately 689 

IVD manufacturers annually. The 

number of hours per response for the 

glossary and educational outreach 

activities were derived from 

consultation with a trade association 

and FDA personnel. The 4-hour 

estimate for a glossary is based on the 

average time necessary for a 

manufacturer to modify the glossary for 

the specific symbols used in labels or 

labeling for the IVDs manufactured. 

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25008 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration Regulated 

Products: Export Certificates 

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 November 

4, 2010. 

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 0910–0498. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

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61496 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.Capezzuto@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. 

Export of Food and Drug 

Administration Regulated Products: 

Export Certificates—(OMB Control 

Number 0910–0498)—Extension 

In April 1996, a law entitled ‘‘The 

FDA Export Reform & Enhancement Act 

of 1996’’ (FDAERA) amended sections 

801(e) and 802 of the act (21 U.S.C. 

381(e) and 382). It was designed to ease 

restrictions on exportation of 

unapproved pharmaceuticals, biologics, 

and devices regulated by FDA. Section 

801(e)(4) of the FDAERA provides that 

persons exporting certain FDA-regulated 

products may request FDA to certify 

that the products meet the requirements 

of 801(e) and 802 or other requirements 

of the act. This section of the law 

requires FDA to issue certification 

within 20 days of receipt of the request 

and to charge firms up to $175 for the 

certifications. 

This new section of the act authorizes 

FDA to issue export certificates for 

regulated pharmaceuticals, biologics, 

and devices that are legally marketed in 

the United States, as well as for these 

same products that are not legally 

marketed but are acceptable to the 

importing country, as specified in 

sections 801(e) and 802 of the act. FDA 

has developed five types of certificates 

that satisfy the requirements of section 

801(e)(4)(B) of the act: (1) Certificates to 

Foreign Governments, (2) Certificates of 

Exportability, (3) Certificates of a 

Pharmaceutical Product, (4) NonClinical Research Use Only Certificates, 

and (5) Certificates of Free Sale. Table 

1 of this document lists the different 

certificates and details their use: 

Type of Certificate Use 

‘‘Supplementary Information Certificate to Foreign Government Requests’’ 

‘‘Exporter’s Certification Statement Certificate to Foreign Government’’ 

‘‘Exporter’s Certification Statement Certificate to Foreign Government (For 

Human Tissue Intended for Transplantation)’’ 

For the export of products legally marketed in the United 

States 

‘‘Supplementary Information Certificate of Exportability Requests’’ 

‘‘Exporter’s Certification Statement Certificate of Exportability’’ 

For the export of products not approved for marketing in the 

United States (unapproved products) that meet the requirements of sections 801(e) or 802 of the act 

‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ 

‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical Product’’ 

Conforms to the format established by the World Health Organization and is intended for use by the importing country 

when the product in question is under consideration for a 

product license that will authorize its importation and sale 

or for renewal, extension, amending, or reviewing a license 

‘‘Supplementary Information Non-Clinical Research Use Only Certificate’’ 

‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’ 

For the export of a non-clinical research use only product, 

material, or component that is not intended for human use 

which may be marketed in, and legally exported from the 

United States under the act 

Certificate of Free Sale For food, cosmetic products, and dietary supplements that 

may be legally marketed in the United States 

FDA will continue to rely on selfcertification by manufacturers for the 

first three types of certificates listed in 

table 1 of this document. Manufacturers 

are requested to self-certify that they are 

in compliance with all applicable 

requirements of the act, not only at the 

time that they submit their request to 

the appropriate center, but also at the 

time that they submit the certification to 

the foreign government. 

The appropriate FDA centers will 

review product information submitted 

by firms in support of their certificate 

and any suspected case of fraud will be 

referred to FDA’s Office of Criminal 

Investigations for followup. Making or 

submitting to FDA false statements on 

any documents may constitute 

violations of 18 U.S.C. 1001, with 

penalties including up to $250,000 in 

fines and up to 5 years imprisonment. 

In the Federal Register of March 31, 

2010 (75 FR 16137), 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: 

TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1

FDA Center No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Center for Biologics Evaluation and 

Research 2,114 1 2,114 1 2,114 

Center for Drug Evaluation and Research 5,251 1 5,251 2 10,502 

Center for Devices and Radiological 

Health 6,463 1 6,463 2 12,926 

Center for Veterinary Medicine 855 1 855 1 855 

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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61497 

TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

FDA Center No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Center for Food Safety and Applied Nutrition (Three different product categories) 

386 2 772 1.5 1,158 

247 47 11,609 2 23,218 

337 1 337 0.5 169 

Total 15,653 27,401 50,942 

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

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25009 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0477] 

Approval Pathway for Biosimilar and 

Interchangeable Biological Products; 

Public Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

2-day public hearing to obtain input on 

specific issues and challenges 

associated with the implementation of 

the Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act). The 

BPCI Act establishes an abbreviated 

approval pathway for biological 

products that are demonstrated to be 

‘‘highly similar’’ (biosimilar) to, or 

‘‘interchangeable’’ with, an FDAlicensed biological product. The 

purpose of this public hearing is to 

create a forum for interested 

stakeholders to provide input regarding 

the agency’s implementation of the 

statute. FDA will take the information it 

obtains from the public hearing into 

account in its implementation of the 

BPCI Act. 

DATES: The public hearing will be held 

November 2 and 3, 2010, from 8:30 a.m. 

to 4:30 p.m. Individuals who wish to 

present at the public hearing must 

register on or before October 11, 2010. 

Section III of this document provides 

attendance and registration information. 

Electronic or written comments will be 

accepted after the public hearing until 

December 31, 2010. 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Building 

31, Rm. 1503, Silver Spring, MD 20993. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Room 1061, Rockville, MD 20852. 

Identify comments with the 

corresponding docket number found in 

brackets in the heading of this 

document. 

Transcripts of the public hearing will 

be available for review at the Division 

of Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the public 

hearing (see Section VI of this 

document). 

A live webcast of this public hearing 

will be viewable at the following Web 

addresses on the days of the public 

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

NewsEvents/ucm221688.htm. A video 

record of the public hearing will be 

available at the same Web addresses for 

1 year. 

FOR FURTHER INFORMATION CONTACT: 

Sandra J. Benton, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6340, 

Silver Spring, MD 20993, 301–796– 

1042, FAX: 301–847–3529, E-mail: 

biosimilarspublicmtg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 23, 2010, President Obama 

signed into law the Patient Protection 

and Affordable Care Act (Affordable 

Care Act) (Pub. L. 111–148). The 

Affordable Care Act contains a subtitle 

called the Biologics Price Competition 

and Innovation Act of 2009 (BPCI Act) 

that amends the Public Health Service 

Act (PHS Act) and other statutes to 

create an abbreviated approval pathway 

for biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed reference biological 

product (see sections 7001 through 7003 

of the BPCI Act). 

The objectives of the BPCI Act are 

conceptually similar to those of the 

Drug Price Competition and Patent 

Term Restoration Act of 1984 (Pub. L. 

98–417) (commonly referred to as the 

‘‘Hatch-Waxman Act’’), which 

established abbreviated pathways for 

the approval of drug products under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). The BPCI Act aligns with 

FDA’s longstanding policy of permitting 

appropriate reliance on what is already 

known about a drug, thereby saving 

time and resources and avoiding 

unnecessary duplication of human or 

animal testing. The implementation of 

an abbreviated approval pathway for 

biological products can present 

challenges given the scientific and 

technical complexities that may be 

associated with the larger and often 

more complex structure of biological 

products, as well as the processes by 

which such products are manufactured. 

Most biological products are produced 

in a living system such as a 

microorganism, or plant or animal cells, 

whereas small molecule drugs are 

typically manufactured through 

chemical synthesis. 

Section 351(k) of the PHS Act (42 

U.S.C. 262(k)), added by the BPCI Act, 

describes the general requirements for 

an application for a proposed biosimilar 

biological product and an application or 

a supplement for a proposed 

interchangeable biological product. 

A biological product may be 

demonstrated to be ‘‘biosimilar’’ to a 

biological reference product based upon 

data derived from analytical studies, 

animal studies, and a clinical study or 

studies if the product is shown to be 

highly similar to the reference product, 

notwithstanding minor differences in 

clinically inactive components, and if 

there are no clinically meaningful 

differences between the biological 

product and the reference product in 

terms of safety, purity and potency. 

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