6728 Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 

ACTION: Notice of meeting. 

DATES: Thursday, February 19, 2015 

from 9:00 a.m. to 4:30 p.m.; and Friday, 

February 20, 2015 from 9:00 a.m. to 2:00 

p.m. (EST) 

These meetings will be open to the 

general public. 

ADDRESSES: These meetings will be held 

in the U.S. Department of Health and 

Human Services/Hubert H. Humphrey 

Building located at 200 Independence 

Avenue SW., Conference Room 505A, 

Washington, DC 20201. 

Individuals who would like to 

participate via conference call may do 

so by dialing toll-free 888–935–0260, 

when prompted enter pass code: 

3656064. Individuals whose full 

participation in the meeting will require 

special accommodations (e.g., sign 

language interpreting services, assistive 

listening devices, materials in 

alternative format such as large print or 

Braille) should notify Dr. MJ Karimi, 

PCPID Team Lead, via email at 

MJ.Karimie@acl.hhs.gov, or via 

telephone at 202–357–3588, no later 

than Friday, February 13, 2015. The 

PCPID will attempt to accommodate 

requests made after that date, but cannot 

guarantee the ability to grant requests 

received after this deadline. All meeting 

sites are barrier free, consistent with the 

Americans with Disabilities Act (ADA) 

and the Federal Advisory Committee 

Act (FACA). 

Agenda: The Committee Members 

will discuss preparation of the PCPID 

2015 Report to the President, including 

its content and format, and related data 

collection and analysis required to 

complete the writing of the Report. They 

will also receive presentations from 

selected experts in the field of 

Technology for People with Intellectual 

and Developmental Disabilities. 

Additional Information: For further 

information, please contact Dr. MJ 

Karimi, Team Lead, President’s 

Committee for People with Intellectual 

Disabilities, One Massachusetts Avenue 

NW., Room 4206, Washington, DC 

20201. Telephone: 202–357–3588. Fax: 

202–205–8037. Email: MJ.Karimie@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

PCPID acts in an advisory capacity to 

the President and the Secretary of 

Health and Human Services, through 

the Administration on Intellectual and 

Developmental Disabilities, on a broad 

range of topics relating to programs, 

services and supports for persons with 

intellectual disabilities. The PCPID 

Executive Order stipulates that the 

Committee shall: (1) Provide such 

advice concerning intellectual 

disabilities as the President or the 

Secretary of Health and Human Services 

may request; and (2) provide advice to 

the President concerning the following 

for people with intellectual disabilities: 

(A) Expansion of educational 

opportunities; (B) promotion of 

homeownership; (C) assurance of 

workplace integration; (D) improvement 

of transportation options; (E) expansion 

of full access to community living; and 

(F) increasing access to assistive and 

universally designed technologies. 

Dated: January 28, 2015. 

Aaron Bishop, 

Commissioner, Administration on Intellectual 

and Developmental Disabilities (AIDD). 

[FR Doc. 2015–02514 Filed 2–5–15; 8:45 am] 

BILLING CODE P 

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 March 9, 

2015. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

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 and Enhancement 

Act of 1996’’ (FDAERA) amended 

sections 801(e) and 802 of the FD&C 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 FD&C 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 section of the FD&C 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 FD&C Act. FDA has 

developed four types of certificates that 

satisfy the requirements of section 

801(e)(4)(B) of the FD&C Act: (1) 

Certificates to Foreign Governments, (2) 

Certificates of Exportability, (3) 

Certificates of a Pharmaceutical Product, 

and (4) Non-Clinical Research Use Only 

Certificates. Table 1 of this document 

lists the different certificates and details 

their use: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 6729 

TABLE 1—CERTIFICATES AND USES

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 FD&C 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 

FD&C Act. 

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 FD&C 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 follow up. 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 November 

14, 2014 (79 FR 68277), 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 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center and FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research .................... 2,114 1 2,114 1 2,114 

FDA 3613.

FDA 3613a.

FDA 3613b.

FDA 3613c.

Center for Devices and Radiological Health ....................... 10,528 1 10,528 2 21,056 

FDA 3613.

FDA 3613a.

FDA 3613c.

Center for Veterinary Medicine ............................................ 855 1 855 1 855 

FDA 3613.

FDA 3613a.

FDA 3613b.

Total .............................................................................. ........................ ........................ ........................ ........................ 24,025 

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

Dated: January 30, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02348 Filed 2–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1168] 

Generic Drug User Fee Amendments of 

2012; September 2014 Public Hearing 

on Policy Development; Reopening of 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of docket; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

reopening of the docket to solicit public 

comment on certain topics related to 

implementation of the Generic Drug 

User Fee Amendments of 2012 (GDUFA) 

and the GDUFA Commitment Letter that 

accompanies the legislation. A public 

hearing in September 2014 provided an 

opportunity for public input on future 


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