Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24961 

Kimberly S. Lane, 

Deputy Director, Office of Science Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–10035 Filed 4–25–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0902] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

Product Labeling: Medication Guide 

Requirements 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by May 29, 

2012. 

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 0910–0393. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

juanmanuel.vilela@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. 

Prescription Drug Product Labeling; 

Medication Guide Requirements (OMB 

Control Number 0910–0393)—Extension 

FDA regulations require the 

distribution of patient labeling, called 

Medication Guides, for certain 

prescription human drug and biological 

products used primarily on an 

outpatient basis that pose a serious and 

significant public health concern 

requiring distribution of FDA-approved 

patient medication information. These 

Medication Guides inform patients 

about the most important information 

they should know about these products 

in order to use them safely and 

effectively. Included is information such 

as the drug’s approved uses, 

contraindications, adverse drug 

reactions, and cautions for specific 

populations, with a focus on why the 

particular product requires a Medication 

Guide. These regulations are intended to 

improve the public health by providing 

information necessary for patients to use 

certain medication safely and 

effectively. 

The regulations contain the following 

reporting requirements that are subject 

to the PRA. The estimates for the burden 

hours imposed by the following 

regulations are listed in table 1 of this 

document: 

• 21 CFR 208.20—Applicants must 

submit draft Medication Guides for FDA 

approval according to the prescribed 

content and format. 

• 21 CFR 208.24(e)—Each authorized 

dispenser of a prescription drug product 

for which a Medication Guide is 

required, when dispensing the product 

to a patient or to a patient’s agent, must 

provide a Medication Guide directly to 

each patient unless an exemption 

applies under 21 CFR 208.26. 

• 21 CFR 208.26 (a)—Requests may 

be submitted for exemption or deferral 

from particular Medication Guide 

content or format requirements. 

• 21 CFR 314.70(b)(3)(ii) and 21 CFR 

601.12(f)—Application holders must 

submit changes to Medication Guides to 

FDA for prior approval as supplements 

to their applications. 

In the Federal Register of December 

21, 2011 (76 FR 79194), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received the following 

comments: 

(Comment 1) One comment states that 

FDA’s hourly burden estimate of 3 

minutes per Medication Guide for 

pharmacists to comply with the 

requirements is miscalculated, although 

more in line with current practices 

versus previous FDA estimates. 

(Response) Because the comment did 

not indicate if the miscalculation was 

over-or under-estimated or provide 

alternative burden estimates for 

pharmacy time associated with 

distribution of a Medication Guide, we 

continue to use 3 minutes as the 

estimated burden for pharmacists to 

distribute Medication Guides to 

patients. 

(Comment 2) One comment said that 

there are distributor costs to comply 

with the Medication Guide 

requirements and FDA’s estimate omits 

§ 208.24(c), which provides that ‘‘Each 

distributor or packer that receives 

Medication Guides, or the means to 

produce Medication Guides, from a 

manufacturer under paragraph (b) of 

this section shall provide those 

Medication Guides, or the means to 

produce Medication Guides, to each 

authorized dispenser to whom it ships 

a container of drug product.’’ The 

comment states that the December 21, 

2011, notice of proposed information 

collection (76 FR 79194) does not 

include an estimate for the reporting 

requirements of § 208.24(c) and that the 

requirement should be included in 

FDA’s assessment. 

(Response) FDA has re-evaluated 

§ 208.24(c) with regards to information 

collection burden on distributors and 

packers and determined that § 208.24(c) 

does not contain an additional 

collection of information subject to the 

reporting requirements of the PRA. A 

‘‘collection of information’’ includes an 

Agency request or requirement that 

members of the public submit reports, 

keep records, or provide information to 

third parties or the public by or for an 

Agency. Therefore, the manufacturer is 

responsible for providing information to 

third parties (§ 208.24(a)), i.e., 

Medication Guides, and the distributor 

or packer distributes the Medication 

Guides with the shipment of drugs to 

the dispensers. Thus, § 208.24(c) is not 

subject to the reporting requirements of 

the PRA. 

(Comment 3) One comment says that 

FDA should reassess the need to 

provide Medication Guides with each 

prescription refill and states there are 

situations where it is not necessary due 

to certain circumstances. The comment 

states that Medication Guides should be 

a tool to enhance the level of care to 

consumers, rather than a hindrance to 

pharmacists in their ability to provide 

quality patient care. 

(Response) FDA agrees and directs the 

comment to the guidance made 

available to the public entitled 

‘‘Medication Guides—Distribution 

Requirements and Inclusion in Risk 

Evaluation and Mitigation Strategies 

(REMS).’’ In this guidance, FDA 

articulates the circumstances under 

which FDA intends to exercise 

enforcement discretion regarding the 

requirement to provide Medication 

Guides in certain settings. 


tkelley on DSK3SPTVN1PROD with NOTICES
24962 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

(Comment 4) One comment states that 

Medication Guides increasingly become 

accessible online for download and 

print and the costs for printing, 

including paper, toner, administrative, 

and software costs, have shifted from 

the manufacturers to the pharmacies. 

(Response) While Medication Guides 

are increasingly available online for 

download and printing, the FDA does 

not agree that a financial and 

acquisition burden has shifted to or 

been created for dispensers. The 

comment mischaracterizes the cost to 

dispensers associated with the 

distribution of Medication Guides. For 

purposes of information collection 

requests under the PRA, capital costs 

are costs for equipment, machinery, and 

construction that, if not for FDA’s 

request or requirement, the respondent 

would not incur. Capital costs do not 

include costs to achieve regulatory 

compliance. The costs presented by the 

comment are not capital costs because 

they are costs associated with achieving 

regulatory compliance with 

requirements of the FD&C Act, not costs 

associated specifically with equipment, 

machinery, and construction needed to 

retain appropriate substantiating 

evidence. 

(Comment 5) One comment states that 

the length of Medication Guides 

continues to be burdensome and 

hinders a pharmacist from utilizing a 

potentially effective tool. The comment 

stresses the need for a succinct, onepage document that can be easily 

integrated into current pharmacy 

practice workflow. 

(Response) FDA generally agrees with 

the comment and is currently in the 

process of evaluating whether a onepage solution can be implemented. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual responses Average burden per 

response Total hours 

208.20 .................................... 25 1 25 320 8,000 

314.70(b)(3)(ii), 601.12(f) ...... 5 1 5 72 360 

208.24(e) ............................... 59,000 5,000 295 million 3 minutes 14,750,000 

208.26(a) ............................... 1 1 1 4 4 

Total ............................... ........................ ........................ ............................................... ............................................... 14,758,364 

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

Dated: April 20, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–10022 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 

(44 U.S.C. chapter 35). To request a 

copy of the clearance requests submitted 

to OMB for review, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1984. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Assessing Factors 

That Impact AIDS Drug Assistance 

Program (ADAP) Enrollment and 

Management in the Face of ADAP 

Waiting Lists (OMB No. 0915–xxxx)— 

[New] 

HRSA’s AIDS Drug Assistance 

Program (ADAP) provides assistance to 

help low-income, uninsured and 

underinsured individuals living with 

HIV/AIDS get access to life-saving 

medications. As part of the Ryan White 

HIV/AIDS Program, ADAP is the payer 

of last resort. Clients enrolled in ADAP 

have exhausted all other resources to 

obtain necessary medications and care. 

In recent years, ADAP has experienced 

an increase in enrollment while funding 

resources have decreased. 

This study will use case study 

methods to identify and examine factors 

that contribute to the rising enrollments 

in ADAP and States’ abilities to meet 

demands for ADAP services. Data 

collection will include interviews with 

up to eight respondents in each of eight 

selected states, for a maximum of 64 

total respondents. Each interview will 

last approximately one and a half hours. 

The respondents fall into three general 

categories—ADAP personnel, State HIV/ 

AIDS program leads, and personnel 

from related State and local programs 

such as Medicaid and pharmacy 

assistance programs. Interviews will be 

conducted over a period of two and a 

half months. 

The proposed study will assess factors 

that may contribute to the rise in ADAP 

enrollment and costs such as new HIV 

cases, earlier use of antiretroviral 

medications, lower attrition of existing 

clients, unemployment and loss of 

insurance, or increasing drug costs. In 

addition, the study will examine factors 

that may decrease ADAP costs such as 

health care reform and cost containment 

strategies. Findings from the study will 

be used to develop policy and to 

recommend promising practices for 

managing ADAPs. 

The annual estimate of burden is as 

follows: 

Activity Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

ADAP Site Visit Coordination .......................... 8 1 8 1 8 

Instrument: 

ADAP Personnel Interview ....................... 32 1 32 1.5 48 

State HIV/AIDS Lead Interview ................ 8 1 8 1.5 12 


tkelley on DSK3SPTVN1PROD with NOTICES