61872 Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 

URL: https://www.mymeetings.com/nc/

join/. 

Conference number: PW8992754. 

Audience passcode: 4798. 

Participants can join the event directly at: 

https://www.mymeetings.com/nc/

join.php?i=PW8992754&p=4798&t=c. 

There is also a toll number for anyone 

outside of the USA: 

TOLL PHONE #: 1 (312) 470–7387. 

Participant passcode: 4798. 

Status: Open to the public, limited only by 

space and net conference and audio phone 

lines available. 

Purpose: The committee is charged with 

advising the Secretary, Department of Health 

and Human Services, and the Director, CDC, 

regarding the early detection and control of 

breast and cervical cancer. The committee 

makes recommendations regarding national 

program goals and objectives; 

implementation strategies; and program 

priorities including surveillance, 

epidemiologic investigations, education and 

training, information, dissemination, 

professional interactions and collaborations, 

and policy. 

Matters for Discussion: The agenda will 

include: (1) Discussing the impact of 

implementation of the Affordable Care Act 

on the National Breast and Cervical Cancer 

Early Detection Program (NBCCEDP); (2) 

assessing the needs of the public and impact 

to the NBCCEDP; (3) population-based 

activities to increase appropriate screening; 

(4) screening communication tools; (5) 

provider risk assessments. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Jameka R. Blackmon, MBA, CMP, Designated 

Federal Officer, National Center for Chronic 

Disease Prevention and Health Promotion, 

CDC, 4770 Buford Highway NE., Mailstop 

F76, Atlanta, Georgia 30341, Telephone (770) 

488–4880. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Claudette Grant, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–24442 Filed 10–14–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1491] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Survey of 

Pharmacists and Patients; Variations 

in the Physical Characteristics of 

Generic Drug Pills and Patients’ 

Perceptions 

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 

the information collection associated 

with a survey of pharmacists and 

patients about their experiences 

resulting from changes in generic drug 

pill appearance. 

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 

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. 

Survey of Pharmacists and Patients: 

Variations in the Physical 

Characteristics of Generic Drug Pills 

and Patients’ Perceptions—(OMB 

Control Number 0910–NEW) 

Generic drugs make up approximately 

85 percent of all human prescription 

drugs prescribed in the United States. 

While generic drugs are required to be 

pharmaceutically equivalent and 

bioequivalent to their brand-name 

counterparts, generics made by different 

manufacturers may differ substantially 

from their brand-name therapeutic 

equivalents and from each other in their 

physical appearance (e.g., color, shape, 

or size of pills). When pharmacists 

switch generic drug suppliers, patients 

refilling their generic prescriptions may 

therefore experience changes in their 

drugs’ appearances. These changes may 

result in patient confusion and concerns 

about the safety and effectiveness of the 

generic drug products. Studies indicate 

that patients are more likely to stop 

taking their generic medications when 

they experience a change in their drugs’ 

physical appearances, leading to 

harmful clinical and public health 

consequences as well as increased 

health care costs from avoidable 

morbidity and mortality. 

To provide additional information 

that may help guide regulatory policy or 

pharmacy business practices, we intend 

to conduct surveys of pharmacists and 

patients about their perceptions about 

and experiences with generic drug 


tkelley on DSK3SPTVN1PROD with NOTICES
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