Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68277 

with the FD&C Act. In the past, 

commenters have argued that FDA’s 

burden estimate is too low. FDA 

carefully considered the issue and 

believes that burden estimates of greater 

than 20 hours are likely to include the 

burden associated with researching and 

generating safety data for a new dietary 

ingredient. Under section 413(a)(2) of 

the FD&C Act, a dietary supplement that 

contains a new dietary ingredient is 

deemed to be adulterated unless there is 

a history of use or other evidence of 

safety establishing that the new dietary 

ingredient will reasonably be expected 

to be safe under the conditions of use 

recommended or suggested in the 

labeling of the dietary supplement. This 

requirement is separate from and 

additional to the requirement to submit 

a premarket notification for the new 

dietary ingredient. FDA’s regulation on 

new dietary ingredient notifications, 

§ 190.6(a), requires the manufacturer or 

distributor of the dietary supplement or 

of the new dietary ingredient to submit 

to FDA the information that forms the 

basis for its conclusion that a dietary 

supplement containing the new dietary 

ingredient will reasonably be expected 

to be safe. Thus, § 190.6 only requires 

the manufacturer or distributor to 

extract and summarize information that 

should have already been developed to 

meet the safety requirement in section 

413(a)(2) of the FD&C Act. FDA 

estimates that extracting and 

summarizing the relevant information 

from what exists in the company’s files 

and presenting it in a format that meets 

the requirements of § 190.6 will take 

approximately 20 hours of work per 

notification. However, FDA seeks 

comments on this estimate. FDA 

encourages comments offering 

alternative burden estimates to include 

documentation to support the 

alternative estimate. 

FDA further estimates that 55 

respondents will submit 1 premarket 

notification each. FDA bases its estimate 

of the number of respondents on 

notifications received over the past 3 

years, which averaged about 55 

notifications per year. 

Dated: November 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26998 Filed 11–13–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0161] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements 

imposed on firms that intend to export 

to countries that require an export 

certificate as a condition of entry for 

FDA regulated products, 

pharmaceuticals, biologics, and devices 

as indicated in the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) as 

amended. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

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. 

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) 

mstockstill on DSK4VPTVN1PROD with NOTICES

68278 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 

and 802 of the FD&C Act. FDA has 

developed five 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: 

TABLE 1—CERTIFICATES AND USES

Type of certificate Use 

‘‘Supplementary Information Certificate to Foreign Government Requests’’.For the export of products legally marketed in the United States. 

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

‘‘Exporter’s Certification Statement Certificate to Foreign Government 

(For Human Tissue Intended for Transplantation)’’.

‘‘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. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center 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 

Center for Devices and Radiological Health ....................... 6,463 1 6,463 2 12,926 

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

Total .............................................................................. ........................ ........................ ........................ ........................ 15,895 

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

Dated: November 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26999 Filed 11–13–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1819] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Spousal Influence 

on Consumer Understanding of and 

Response to Direct-To-Consumer 

Prescription Drug Advertisements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

research entitled, ‘‘Spousal Influence on 

Consumer Understanding of and 

Response to Direct-To-Consumer (DTC) 

Prescription Drug Advertisements.’’ 

This study will examine differences 

between consumers viewing 

prescription drug ads with a spouse or 

partner versus alone through empirical 

research. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

mstockstill on DSK4VPTVN1PROD with NOTICES