Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 61873 

product pill appearance change. These 

surveys are intended to further our 

understanding of the relationship 

between changes in pill appearance and 

non-adherence to prescribed therapeutic 

regimens. The surveys may enable us to 

investigate factors that may explain the 

association between changes in pill 

appearance and non-adherence, 

including which factors could be 

modified to improve the safe and 

effective use of generic drugs. 

We intend to survey a national cohort 

of pharmacists about their experiences 

with dispensing generic drug pills that 

differ in appearance from previous 

refills of the same medication and 

dosage level (e.g., when pharmacies 

switch generic suppliers). A stratified, 

random sample of U.S.-licensed 

pharmacists will be obtained based on 

a master list from KM Lists. The target 

sample includes pharmacists with 

active licenses who practice in 

traditional community pharmacy 

settings and will be proportionally 

allocated across the United States in 

relation to the number of pharmacists in 

each state. Based on an 11 percent 

undeliverable rate and a 52 percent 

response rate, 2,161 questionnaires will 

be mailed to pharmacists to obtain the 

1,000 responses required for adequate 

statistical power. The pharmacists’ 

survey will consist of a mailed 

questionnaire rather than a telephone 

survey or an email survey. Prior 

experience conducting surveys has 

shown that it is easier to guarantee 

respondent anonymity using an 

impersonal, mailed questionnaire with 

no individual identifying information. 

The pharmacists will be asked about the 

frequency with which their pharmacy 

changes suppliers that lead to variations 

in the appearance of the generic drugs 

that they dispense, as well as strategies 

they use with patients to address the 

transition to pills that have a different 

appearance (e.g., alert stickers on pill 

bottles, verbal warnings, and other 

strategies). They will also be asked 

about patient responses to changes in 

pill appearance, including what types of 

appearance changes seem to affect 

patients most often (shape/color/size), 

how often patients report confusion 

about pill appearance, and how often 

patients ultimately refuse to accept the 

new product. Participation is expected 

to take approximately 20 minutes. 

We also intend to survey two different 

patient samples using two 

methodologies. The first is a telephone 

survey of patients who are 50 years and 

older and who take one or more generic 

medications for at least one of the 

following chronic conditions: Epilepsy, 

diabetes, hypertension, hyperlipidemia, 

depression, and HIV. The telephone 

survey will be generalizable and will 

consist of well-defined methods to 

minimize sampling bias such as use of 

random phone numbers for both 

landlines and mobile phones, as well as 

small-batch sampling to ensure a high 

response rate that meets demographic 

diversity goals. For the second patient 

survey, patients will be selected from a 

proprietary research database of 

commercially insured patients 

containing medical and pharmacy 

claims linked to health insurance 

enrollment information. A nationally 

representative sample of patients with at 

least one chronic condition and who 

experienced a change in physical 

appearance of a generic pill will be 

identified by the research team using 

medical and pharmacy claims data. 

Both patient surveys will consist of 

questions covering topics similar to 

those asked in the survey of pharmacists 

and is intended to provide answers to 

the same topic areas from patients’ 

perspectives. As before, topic areas will 

include beliefs about generic drugs, 

outcomes related to changes in generic 

drug pill appearance, and strategies 

used by pharmacists or doctors to alert 

patients to the possibility of changes in 

appearance. Participation is expected to 

take approximately 20 minutes. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED REPORTING BURDEN 1

Surveys of pharmacists and patients on variations in the 

physical characteristics of generic drug pills and patients’ 

perceptions 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Survey of Pharmacists ......................................................... 1,000 1 1,000 0.333 

(20 minutes) 

333 

Survey of Patients #1 .......................................................... 1,000 1 1,000 0.333 

(20 minutes) 

333 

Survey of Patients #2 .......................................................... 1,000 1 1,000 0.333 

(20 minutes) 

333 

Total .............................................................................. ........................ ........................ ........................ ........................ 999 

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

Dated: October 8, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24365 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0078] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Animal Drug User Fee Cover Sheet 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Animal Drug User Fee Cover Sheet’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: On July 8, 

2014, the Agency submitted a proposed 

collection of information entitled 

‘‘Animal Drug User Fee Cover Sheet’’ to 

OMB for review and clearance under 44 


tkelley on DSK3SPTVN1PROD with NOTICES
61874 Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0539. The 

approval expires on August 31, 2017. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24444 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Class II Special 

Controls Guidance Document: 

Labeling of Natural Rubber Latex 

Condoms 

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 

the information collection for the 

labeling of natural rubber latex 

condoms. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 15, 2014. 

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. 

Class II Special Controls Guidance 

Document: Labeling for Natural Rubber 

Latex Condoms Classified Under 21 

CFR 884.5300—(OMB Control Number 

0910–0633)—Extension 

Under the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

class II devices were defined as those 

devices for which there was insufficient 

information to show that general 

controls themselves would provide a 

reasonable assurance of safety and 

effectiveness but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. 

Condoms without spermicidal 

lubricant containing nonoxynol 9 are 

classified in class II. They were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), which broadened the 

definition of class II devices and now 

permit FDA to establish special controls 

beyond performance standards, 

including guidance documents, to help 

provide reasonable assurance of the 

safety and effectiveness of such devices. 

In December 2000 Congress enacted 

Public Law 106–554, which, among 

other provisions, directed FDA to 

‘‘reexamine existing condom labels’’ 

and ‘‘determine whether the labels are 

medically accurate regarding the overall 

effectiveness or lack of effectiveness in 

preventing sexually transmitted diseases 

* * *.’’ In response, FDA recommended 

labeling intended to provide important 

information for condom users, including 

the extent of protection provided by 

condoms against various types of 

sexually transmitted diseases. 

Respondents to this collection of 

information are manufacturers and 

repackagers of male condoms made of 

natural rubber latex without spermicidal 

lubricant. FDA expects approximately 5 

new manufacturers or repackagers to 

enter the market yearly and to 

collectively have a third-party 

disclosure burden of 60 hours. The 

number of respondents cited in table 1 

of this document is based on FDA’s 

database of premarket submissions and 

the electronic registration and listing 

database. The average burden per 

disclosure was derived from a study 

performed for FDA by Eastern Research 

Group, Inc., an economic consulting 

firm, to estimate the impact of the 1999 

over-the-counter (OTC) human drug 

labeling requirements final rule (64 FR 

13254, March 17, 1999). Because the 

packaging requirements for condoms are 

similar to those of many OTC drugs, we 

believe the burden to design the labeling 

for OTC drugs is an appropriate proxy 

for the estimated burden to design 

condom labeling. 

The special controls guidance 

document also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 807 

subpart E have been approved under 

OMB control number 0910–0120; and 

the collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073. 


tkelley on DSK3SPTVN1PROD with NOTICES