Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74063 

FDA Center Director. Except when 

initiated by an FDA Center Director, a 

request for an exception or alternative 

must be in writing and must: 

• Identify the specified lots, batches, 

or other units of the affected product; 

• Identify the specific labeling 

provisions under this rule that are the 

subject of the request; 

• Explain why compliance with the 

specified labeling provisions could 

adversely affect the safety, effectiveness, 

or availability of the product subject to 

the request; 

• Describe any proposed safeguards 

or conditions that will be implemented 

so that the labeling of the product 

includes appropriate information 

necessary for the safe and effective use 

of the product given the anticipated 

circumstances of use of the product; 

• Provide copies of the proposed 

labeling of the specified lots, batches, or 

other units of the affected product that 

will be subject to the exception or 

alternative; and 

• Provide any other information 

requested by the FDA Center Director in 

support of the request. 

If the request is granted, the 

manufacturer may need to report to FDA 

any resulting changes to the New Drug 

Application, Biologics License 

Application, Premarket Approval 

Application or Premarket Notification 

(510(k)) in effect, if any. The submission 

and grant of an exception or an 

alternative to the labeling requirements 

specified in the interim final rule (72 FR 

73589) may be used to satisfy certain 

reporting obligations relating to changes 

to product applications under § 314.70 

(21 CFR 314.70) (human drugs), § 601.12 

(21 CFR 601.12) (biological products), 

§ 814.39 (21 CFR 814.39) (medical 

devices subject to premarket approval), 

or § 807.81 (21 CFR 807.81) (medical 

devices subject to 510(k) clearance 

requirements). The information 

collection provisions in §§ 314.70, 

601.12, 807.81, and 814.39 have been 

approved under OMB control numbers 

0910–0001, 0910–0338, 0910–0120, and 

0910–0231, respectively. On a case-bycase basis, the appropriate FDA Center 

Director may also determine when an 

exception or alternative is granted that 

certain safeguards and conditions are 

appropriate, such as additional labeling 

on the SNS products, so that the 

labeling of such products would include 

information needed for safe and 

effective use under the anticipated 

circumstances of use. 

Respondents to this collection of 

information are entities that 

manufacture (including labeling, 

packing, relabeling, or repackaging), 

distribute or store affected SNS 

products. Based on the number of 

requests for an exception or alternative 

received by FDA since issuance of the 

interim final rule, FDA estimates an 

average of two requests annually. FDA 

is estimating that each respondent will 

spend an average of 24 hours preparing 

each request. The hours per response for 

each submission are based on the 

estimated time that it takes to prepare a 

supplement to an application, which 

may be considered similar to a request 

for an exception or alternative. To the 

extent that labeling changes not already 

required by FDA regulations are made 

in connection with an exception or 

alternative granted under the interim 

final rule, FDA is estimating one 

occurrence annually in the event FDA 

would require any additional labeling 

changes not already covered by FDA 

regulations, and that it would take 8 

hours to develop and revise the labeling 

to make such changes. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and 

809.11(b)(1)(i) ................................................................... 2 1 2 24 48 

201.26(b)(1)(i), 610.68(b)(1)(i), ............................................

801.128(b)(1)(i), and 809.11(b)(1)(i) .................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 56 

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

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30036 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0576] 

Supplemental Funding Under the Food 

and Drug Administration’s Convener of 

Active Medical Product Surveillance 

Discussions (U13) RFA–FD–09–012; 

Request for Supplemental Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of intent. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

program expansion of its Conference 

Cooperative Agreement Program (U13), 

awarded to the Engelberg Center for 

Health Care Reform at the Brookings 

Institution (Brookings). The goal of this 

expansion is to plan and hold meetings 

and conferences that will ensure broad 

stakeholder input on FDA programs and 

initiatives related to disseminating 

information from active medical 

product surveillance activities and other 

sources of product information. 

DATES: Important dates are as follows: 

1. The supplemental application due 

date is December 13, 2010. 

2. The award anticipated start date is 

January 1, 2011. 

3. The opening date is November 30, 

2010. 

4. The expiration date is December 14, 

2010. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Melissa Robb, Office of Medical Policy, 

Food and Drug Administration, 10903 

New Hampshire Ave, Bldg. 51, rm. 

6360, Silver Spring, MD 20993–0002, 

301–796–2500, e-mail: 

Melissa.Robb@fda.hhs.gov; or 

Camille R. Peake, Division of 

Acquisition Support and Grants, Food 

and Drug Administration, 5630 

Fishers Lane (HFA–500), Rockville, 

MD 20857, 301–827–7175, FAX: 301– 

827–7101, e-mail: 

Camille.Peake@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


jdjones on DSK8KYBLC1PROD with NOTICES
74064 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 

I. Funding Opportunity Description 

For more information on the original 

full funding opportunity announcement 

(FOA) RFA–FD–09–012, go to http:// 

www.fda.gov/Safety/ 

FDAsSentinelInitiative/ucm168759.htm. 

A. Background 

This FOA, issued by FDA, announces 

a proposed program expansion of FDA’s 

Conference Cooperative Agreement 

Grant U13 FD003802 awarded to 

Brookings. The goal of this program is 

to plan and hold meetings and 

conferences that will ensure broad 

stakeholder input on FDA programs and 

initiatives related to disseminating 

information from active medical 

product surveillance activities and other 

sources of product information. The 

information obtained through these 

meetings and workshops is being used 

to develop, implement, and evaluate 

medical product surveillance methods 

and systems, which support the 

gathering, analysis, and communication 

of medical product safety information. 

Supplementing the parent grant to 

incorporate expansion of the scope of 

work would support activities including 

convening discussions, leveraging the 

information learned from medical 

product surveillance, and engaging 

stakeholders, namely the health care 

community, consumers and industry, on 

topics related to patient counseling and 

dissemination of product information 

on the risks, benefits, and safe use of 

prescription drugs. Discussions would 

cover issues related to developing a 

quality systems approach to make sure 

that user-friendly, easily accessible, upto-date information is available to the 

public and health care practitioners who 

are interacting with patients to prescribe 

and dispense medications. It is 

important that practitioners and 

pharmacists are able to adequately 

inform patients about the proper use of 

medications being prescribed or 

dispensed. This supplement would 

include convening meetings and 

synthesizing, summarizing, and 

communicating the findings on topics 

such as those listed in the Research 

Objectives. (See section B of this 

document.) 

During Year 1, a supplement was 

awarded that allowed for the convening 

of discussions on topics related to the 

development and appropriate 

dissemination of Patient Medication 

Information (PMI). With this FOA, FDA 

proposes to further expand the scope of 

work of the 2009 supplement and 

increase the amount of supplemental 

funding for each budget year to 

$501,534 total cost (direct costs only), 

beginning in 2010, and future years 

2011, 2012, and 2013. (Funding for this 

supplement will be subject to 

availability of funds and satisfactory 

progress of the project). 

B. Research Objectives 

This supplement will expand the 

existing program to convene meetings 

and synthesize, summarize, and 

communicate relevant findings on 

topics such as those discussed in the 

following paragraphs. 

• Patient Medication Information (PMI) 

To be able to use prescription 

medications safely, consumers need to 

receive clear, actionable medication 

information that is accurate, balanced, 

and delivered in a consistent and easily 

understood format. In February 2009, 

FDA’s Risk Communication Advisory 

Committee recommended FDA adopt a 

single, standard document for 

communicating essential information 

about prescription drugs, which would 

replace Consumer Medical Information, 

Patient Package Insert (PPI), and 

Medication Guides. Such changes to the 

delivery of PMI may require changes to 

the Federal Food, Drug, and Cosmetics 

Act law and/or regulations to 

implement. Following a series of public 

workshops convened by FDA, the 

Agency developed three draft patient 

information prototypes as well as a 

strategy for evaluating the prototypes. 

Upon approval from the Office of 

Management and Budget, FDA plans to 

evaluate the three prototypes using an 

experimental consumer testing study. 

As part of its evaluation process, FDA 

intends to hold a series of workshops to 

ensure continued, broad public input on 

the prototypes. In addition, Brookings 

also convened three workshops in 

cooperation with FDA (Year 1) to 

discuss optimizing, implementing, and 

evaluating adoption of a single, standard 

medication information document. As a 

followup to the outcomes and 

recommendations received from the 

meetings described previously, FDA is 

interested in obtaining additional 

feedback, guidance, and expert opinion 

from a broad range of stakeholders 

during the supplemented years needed 

to move the PMI initiative forward, 

including, for example, through pilot 

projects for PMI distribution using 

modern media and exploration of 

additional issues related to PMI 

monitoring, compliance, and 

enforcement, as well as by developing 

processes for follow-up assessments. 

• Professional Labeling 

In the Federal Register of January 24, 

2006 (71 FR 3922), FDA published a 

final rule that amended the 

requirements for the content and format 

of the package insert for human 

prescription drug and biologic products. 

The purpose of the new requirements 

was to improve the management of the 

risks of medical product use and reduce 

medical errors by health care 

professionals, as well as enable health 

care practitioners to better communicate 

risk information to their patients. The 

new regulation (21 CFR 201.57) was 

designed to make information in the 

prescription package insert easier for 

health care practitioners to access, read, 

and use, thereby facilitating use of the 

package insert to make prescribing 

decisions. The final rule has a phasedin implementation schedule that 

initially targets new and recently 

approved drugs. These new 

requirements have been in effect for 

4 years, and many drugs on the market 

have package inserts in the new format. 

Because complying with these new 

requirements is essential for meeting the 

objective of better risk communication, 

FDA is interested in obtaining feedback 

from health care practitioners on 

whether the new package insert format 

is being implemented in a manner that 

meets the needs of the practicing 

physician and other health care 

practitioners or whether there are areas 

in which FDA could improve 

implementation. 

• Risk Evaluation and Mitigation 

Strategies (REMS) 

With the additional regulatory 

authority granted to FDA in the FDA 

Amendments Act of 2007, FDA has 

begun requiring REMS, with the 

components of each individual strategy 

varying by the risks involved and 

patient populations eligible. 

Based on existing FDA guidance, 

REMS components have included 

medication guides (‘‘MedGuides’’); 

patient package inserts; communication 

plan(s) for health care practitioners (e.g. 

‘‘Dear Provider’’ letters); and elements to 

assure safe use (ETASU), including 

requirements for those who prescribe, 

dispense, or use the drug. In some cases, 

MedGuides have been the only 

component required; in other cases, 

FDA has required ETASU of varying 

designs, such as those requiring that a 

drug be dispensed to patients with 

evidence (e.g., restricted distribution) or 

other documentation of safe-use 

conditions (e.g., certain laboratory test 

result outcomes required before a drug 

may be dispensed). 

The current REMS requirement 

process has led to the implementation of 

more than 100 new strategies, with 

varying elements based on the severity 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74065 

of risk projected and different 

approaches taken by manufacturers 

seeking to meet those requirements. 

FDA would like to convene sessions of 

experts and hold focused meetings over 

the next 3 years to discuss REMS 

implementation to date, and explore 

practical policy approaches relevant to 

restricted distribution processes and 

quality care counseling. 

C. Eligibility Information 

This supplement is available only to 

the existing grant recipient, Brookings. 

D. Requirements of the Supplemental 

Application 

1. The application clearly 

demonstrates an understanding of the 

purpose and objectives of the program 

expansion as described in section B of 

this document. 

2. The application clearly describes 

the steps involved in a proposed 

schedule for planning, implementing, 

and accomplishing the activities to be 

carried out under the program 

expansion. 

3. The application establishes 

Brookings ability to perform the 

responsibilities under the program 

expansion including the availability of 

appropriate staff and sufficient funding. 

4. The application describes 

Brookings ability to act as a neutral, 

independent third party to convene a 

wide group of diverse stakeholders with 

relevant expertise related to selected 

topics. 

5. The application specifies the 

manner in which interaction with FDA 

will be maintained throughout the 

lifetime of the project. 

6. The application specifies how 

Brookings will monitor progress of the 

work under the program expansion and 

how progress will be reported to FDA. 

7. The application shall include a 

detailed budget that shows: (1) 

Anticipated costs for personnel, travel, 

communications and postage, and 

supplies and (2) the sources of funds to 

meet those needs, if other than FDA. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates supplementing this 

program expansion by providing 

approximate total cost of $501,534 

(direct costs only) in each budget period 

beginning in 2010, and the remaining 

budget periods (years: 2011, 2012, and 

2013). 

B. Length of Support 

The initial supplemental award will 

be awarded to correspond with the 2010 

budget period, and the remaining 

budget periods (2011, 2012, and 2013) 

will be dependant on the grantee’s 

successful performance, and financial 

management. 

III. Paper Application and Submission 

Information 

To submit a paper application in 

response to this supplemental notice, 

applicants should download the PHS– 

398 form at http://grants.nih.gov/grants/ 

funding/phs398/phs398.html. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

For all paper application submissions, 

the following steps are required: 

Submit paper via Express mail to (see 

the For Further Information and 

Additional Requirements Contact 

section of this document). 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30054 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB), under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Ryan White HIV/ 

AIDS Program Core Medical Services 

Waiver Application Requirements 

(OMB No. 0915–0307)—Extension 

HRSA utilizes standards for granting 

waivers of the core medical services 

requirement for the Ryan White HIV/ 

AIDS Program. These standards meet 

the intent of the Ryan White HIV/AIDS 

Program to increase access to core 

medical services, including 

antiretroviral drugs, for persons with 

HIV/AIDS and to ensure that grantees 

receiving waivers demonstrate the 

availability of such services for 

individuals with HIV/AIDS who are 

identified and eligible under Title XXVI 

of the Public Health Service (PHS) Act. 

The core medical services waiver 

uniform standard and waiver request 

process will apply to Ryan White HIV/ 

AIDS Program Grant awards under Parts 

A, B, and C of Title XXVI of the PHS 

Act. Core medical services waivers will 

be effective for a 1-year period that is 

consistent with the grant award period. 

Title XXVI, Section 2671 of the PHS 

Act, as amended by the Ryan White 

HIV/AIDS Treatment Extension Act of 

2009, Public Law 111–87, (Ryan White 

HIV/AIDS Program), requires that 

grantees expend 75 percent of Parts A, 

B, and C funds on core medical services, 

including antiretroviral drugs, for 

individuals with HIV/AIDS who are 

identified and eligible under the 

legislation. In order for grantees under 

Parts A, B, and C to be exempt from the 

75 percent core medical services 

requirement, they must request and 

receive a waiver from HRSA. 

Grantees must submit the waiver 

request with the annual grant 

application that includes the 

certifications and documentation which 

will be utilized by HRSA in making 

determinations regarding waiver 

requests. Grantees must provide 

evidence that all of the core medical 

services listed in the statute, regardless 

of whether such services are funded by 

the Ryan White HIV/AIDS Program, are 

available to all individuals with HIV/ 

AIDS who are identified and eligible 

under Title XXVI of the PHS Act in the 

service area within 30 days. 

The annual estimate of burden is as 

follows: 


jdjones on DSK8KYBLC1PROD with NOTICES