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. 

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Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68279 

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 

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. 

Spousal Influence on Consumer 

Understanding of and Response to DTC 

Prescription Drug Advertisements— 

(OMB Control Number 0910–NEW) 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes the FDA to 

conduct research relating to health 

information. Section 1003(d)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 393(b)(2)(c)) 

authorizes FDA to conduct research 

relating to drugs and other FDA 

regulated products in carrying out the 

provisions of the FD&C Act. 

Consumers are often thought of as 

individual targets for prescription drug 

advertisements (ads), as if they are 

always exposed to DTC ads individually 

and subsequently make judgments about 

advertised products on their own. 

However, judgments about prescription 

drugs portrayed in DTC ads are likely 

made in social contexts much of the 

time. For example, a potential consumer 

and his or her spouse (e.g., marital or 

domestic partner) may view an ad 

together and discuss drug benefits, side 

effects, and risks. These social 

interactions may result in unique 

reactions relative to consumers who 

view DTC prescription drug ads alone. 

For example, spouses may influence 

their partner by expressing concern 

about risks and side effects that might 

occur, or pressuring their partner to 

consider the drug despite its risks and 

side effects. These outcomes have 

important public health implications. 

The Office of Prescription Drug 

Promotion plans to examine differences 

between consumers viewing 

prescription drug ads with a spouse 

versus alone through empirical research. 

The main study will be preceded by 

pretesting, designed to delineate the 

procedures and measures used in the 

main study. Pretest and main study 

participants will be couples who are 

married or in a marital-like living 

arrangement in which one member 

(consumer) has asthma and the other 

does not (spouse). All participants will 

be 18 years of age or older. We will 

exclude individuals who work in 

healthcare or marketing settings because 

their knowledge and experiences may 

not reflect those of the average 

consumer. Data collection will take 

place in person. 

Participants will be randomly 

assigned to one of four experimental 

conditions in a 2 × 2 design, as depicted 

in Table 1. We will compare one version 

of an ad that depicts a low-benefit and 

low-risk drug with a second version that 

depicts a high-benefit and high-risk 

drug. Participants will be randomly 

assigned to view the ad alone or 

together with their spouse. Participants 

in both viewing conditions will 

individually complete a 

prequestionnaire. In the ‘‘together’’ 

condition, participants will view the ad 

with their spouse and then engage in a 

brief discussion together about the ad. 

In the ‘‘alone’’ condition, participants 

will view the ad without their spouse, 

take a short break, and then respond to 

a postquestionnaire consisting of 

questions about information in the ad. 

The short break in the ‘‘alone’’ 

condition will facilitate reflection about 

the ad to mirror discussion engaged in 

by those in the ‘‘together’’ condition. 

The consumer in the ‘‘together’’ 

condition will complete the same 

postquestionnaire administered to those 

in the ‘‘alone’’ condition, and the 

spouse will complete a slightly different 

questionnaire that assesses key 

measures that relate to consumer 

reactions. These procedures are 

depicted in Table 2. Participation is 

estimated to take approximately 60 

minutes. 

Preliminary measures are designed to 

assess memory and understanding of 

risk and benefit information as well as 

other ad content, intention to seek more 

information about the product, and 

variables pertaining to the consumerspouse relationship such as relationship 

closeness and communication style. The 

draft questionnaire is available upon 

request. 

TABLE 1—EXPERIMENTAL STUDY DESIGN

Viewing condition 

Risk/Benefit condition 

Low risk/low benefit High risk/high benefit 

Alone .................................................................. Condition A ....................................................... Condition B. 

Together ............................................................. Condition C ...................................................... Condition D. 

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68280 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 

TABLE 2—OVERVIEW OF DATA COLLECTION PROCESS FOR ALONE AND TOGETHER CONDITIONS

Steps 

Viewing condition 

Alone Together 

1 ........................... Consumer completes prequestionnaire .................................. Consumer and spouse complete prequestionnaire separately (spouse completes selected measures). 

2 ........................... Consumer views advertising stimuli alone .............................. Consumer and spouse view advertising stimuli together. 

3 ........................... Break ....................................................................................... Couples engage in a 5-minute semistructured conversation 

related to the advertising stimuli. 

4 ........................... Consumer completes postquestionnaire ................................. Consumer and spouse complete postquestionnaire separately (spouse completes selected measures). 

To examine differences between 

experimental conditions, we will 

conduct inferential statistical tests such 

as analysis of variance. With the sample 

size described below, we will have 

sufficient power to detect small-tomedium sized effects in the main study. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Pretesting 

Number to complete the screener ................................................... 700 1 700 0.08 

(5 minutes) 

56 

Number of completes ....................................................................... 120 1 120 1 120 

Main study 

Number to complete the screener ................................................... 4,060 1 4,060 0.08 

(5 minutes) 

325 

Number of completes ....................................................................... 792 1 792 1 792 

Total .......................................................................................... ........................ ........................ ........................ ........................ 1,293 

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

Dated: November 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26918 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–1617] 

Blood Products Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of the meeting 

of the Blood Products Advisory 

Committee. This meeting was 

announced in the Federal Register of 

October 22, 2014. The amendment is 

being made to reflect a change in the 

Agenda portion of the document. There 

are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Bryan Emery or Joanne Lipkind, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6132, Silver Spring, MD 20993, 240– 

402–8054 or 240–402–8129, 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 

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 http://

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: In the 

Federal Register of October 22, 2014 (79 

FR 63131), FDA announced that a 

meeting of the Blood Products Advisory 

Committee would be held on December 

2 and 3, 2014. On page 63131, in the 

third column, the Agenda portion of the 

document is changed to read as follows: 

Agenda: On December 2, 2014, the 

Committee will meet in open session to 

hear scientific data related to 

reconsideration of the current blood 

donor deferral policy for men who have 

had sex with another man (MSM) even 

one time since 1977. The Committee 

will be presented with an update on the 

November 13, 2014, meeting of the U.S. 

Department of Health and Human 

Services Advisory Committee on Blood 

and Tissue Safety and Availability 

where the MSM blood donor deferral 

policy will be discussed. In the 

afternoon, the Committee will hear an 

informational presentation on Ebola 

virus, the potential implications for 

blood safety in the United States and 

FDA’s considerations on the collection 

of convalescent plasma for 

investigational use. 

On December 3, 2014, the Blood 

Products Advisory Committee will be 

seated as a device classification panel. 

In open session, the panel will discuss 

the appropriate device classification of 

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