Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 60677 

Submission of Nominations for the 

Evaluation Set 22 

Proposed Substances: Today’s notice 

also invites voluntary public 

nominations for substances not listed in 

this notice. Nominations are most useful 

if they include the nominator, including 

full name, title, affiliation, email 

address, and telephone number. 

ATSDR will evaluate all data and 

information associated with nominated 

substances and will determine the final 

list of substances that will be chosen for 

toxicological profile development. 

Substances will be chosen according to 

ATSDR’s specific guidelines for 

selection, found in the Selection Criteria 

announced in the Federal Register on 

May 7th, 1993 (87 FR 27288). 

Please submit nominations by one of 

the following methods: 

• E-mail: jxt1@cdc.gov. 

• Fax: 770.488.4178. 

• Mail: CDR Jessilynn Taylor, 1600 

Clifton Rd, NE., MS F32, Atlanta, GA, 

30333. 

Please ensure that your comments are 

submitted within the specified 

nomination period. Nominations 

received after the closing date will be 

marked as late and may be considered 

only if time permits. 

Dated: October 19, 2007. 

Ken Rose, 

Director, Office of Policy, Planning and 

Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. E7–21018 Filed 10–24–07; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 1999N–2337 (formerly Docket 

No. 99N–2337)] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

CGMP for Blood and Blood 

Components; Notification of 

Consignees and Transfusion 

Recipients Receiving Blood and Blood 

Components at Increased Risk of 

Transmitting HCV Infection 

(‘‘Lookback’’) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘CGMP for Blood and Blood 

Components; Notification of Consignees 

and Transfusion Recipients Receiving 

Blood and Blood Components at 

Increased Risk of Transmitting HCV 

Infection (‘‘Lookback’’)’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 24, 2007 (72 

FR 48766), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 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 0910–0610. The 

approval expires on October 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

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

ohrms/dockets. 

Dated: October 19, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–21055 Filed 10–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0278] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on Continuous 

Marketing Applications: Pilot—

Scientific Feedback and Interactions 

During Development of Fast Track 

Products Under the Prescription Drug 

User Fee Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘ Guidance for Industry on Continuous 

Marketing Applications: Pilot—

Scientific Feedback and Interactions 

During Development of Fast Track 

Products Under the Prescription Drug 

User Fee Act‘‘ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Karen L. Nelson, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4816. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 21, 2007 (72 FR 

28495), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 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 0910–0518. The 

approval expires on September 30, 

2010. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

Dated: October 19, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–21056 Filed 10–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N-0390] 

User Fee Program for Advisory Review 

of Direct-to-Consumer Television 

Advertisements for Prescription Drug 

and Biological Products; Request for 

Notification of Participation and 

Number of Advertisements for Review 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for notification 

of participation. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

notice to explain the new direct-toconsumer (DTC) user fee program (DTC 

user fee program) established by the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) and, 

as required by the new law, to ask 

companies to notify FDA within 30 

calendar days if they intend to 

participate in the DTC user fee program 

during fiscal year (FY) 2008 and, if they 

do plan to participate, to identify the 

number of DTC television 

advertisements for prescription drug 

and biological products they plan to 

mstockstill on PROD1PC66 with NOTICES

60678 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 

submit for advisory review during FY 

2008. The information gathered in 

response to this notice will be used to 

establish the FY 2008 fee that will be 

charged for each FY 2008 advisory 

review submission to FDA and to fund 

the operating reserve established under 

FDAAA. 

DATES: Submit written responses by 

November 26, 2007. 

ADDRESSES: Submit written responses 

by overnight courier service to Wayne 

Amchin, Project Manager, Division of 

Drug Marketing, Advertising, and 

Communications (DDMAC), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 1477, 

Silver Spring, MD 20993–0002. For 

companies that use Federal Express or 

DHL for overnight courier service, the 

courier will be able to deliver packages 

directly to DDMAC’s office. Other 

courier services will need to call 301–

796–1200 to request that the DDMAC 

project manager meet the courier at the 

security desk for package pickup. In 

addition, fax a copy of your response to 

301–796–9878 or e-mail a copy to 

dtcp@fda.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions about the DTC user fee 

program, contact Wayne Amchin, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 1477, Silver Spring, 

MD 20993–0002, 301–796–1200, FAX: 

301–796–9878, e-mail: 

dtcp@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

On September 27, 2007, the President 

signed into law FDAAA (Public Law 

110–85). Title I of this statute 

reauthorized the Prescription Drug User 

Fee Act (PDUFA) for FYs 2008 to 2012. 

In addition, Title I also created new 

section 736A of the Federal Food, Drug, 

and Cosmetic Act (the act), which 

authorizes a new and separate user fee 

program for the advisory review of DTC 

prescription drug television 

advertisements. Participation in the 

program is voluntary. Sponsors can 

decide, at their own discretion, whether 

to seek FDA advisory review of DTC 

prescription drug television 

advertisements in advance of publicly 

broadcasting them. However, under the 

new law, if a sponsor decides to seek 

FDA advisory review of a DTC 

television advertisement, the sponsor 

must pay a required fee for that review. 

FDA has agreed to use the resources 

collected under this program to meet 

certain performance goals set forth in an 

enclosure to letters dated September 27, 

2007, from the Secretary of Health and 

Human Services (the Secretary) to the 

Chairmen and Ranking Minority 

Members of the Senate Committee on 

Health, Education, Labor, and Pensions 

and the House of Representatives 

Committee on Energy and Commerce. 

The letters are posted at http:// 

www.fda.gov/cder/pdufa. 

FDA is issuing this Federal Register 

notice to explain the new program and 

to ask companies to notify FDA by 

November 26, 2007: (1) If they intend to 

participate in the FY 2008 DTC user fee 

program and (2) if they do plan to 

participate, to identify the number of 

DTC television advertisements they plan 

to submit for advisory review during FY 

2008 to DDMAC in the Center for Drug 

Evaluation and Research or the 

Advertising and Promotional Labeling 

Branch in the Center for Biologics 

Evaluation and Research. The 

information gathered in response to this 

notice will be used to establish the fees 

that will be charged for each advisory 

review submission to FDA during FY 

2008 and to create an operating reserve. 

II. Background 

FDA’s prescription drug advertising 

regulations give companies the option of 

submitting proposed television 

advertisements to FDA for advisory 

review before publicly disseminating 

them. In this way, companies can 

benefit from FDA’s advice on whether 

or not the advertisements are accurate, 

balanced, and adequately supported. 

The submission of advertisements for 

advisory review gives sponsors the 

opportunity to address any problems 

before the advertisements are shown to 

the public and can improve the quality 

of the advertisements. Companies have 

recognized the benefits of this advisory 

review mechanism, and between 2000 

and 2006, FDA received an average of 

approximately 150 television 

advertisements for advisory review each 

year. Recognizing the value of this 

review, the Pharmaceutical Research 

and Manufacturers of America (PhRMA) 

recently stated in its voluntary guiding 

principles on DTC advertising (see 

‘‘PhRMA Guiding Principles; Direct to 

Consumer Advertisements About 

Prescription Medicines’’ at http:// 

www.phrma.org/files/ 

DTCGuidingprinciples.pdf) that 

companies should submit all new DTC 

television advertisements to FDA before 

broadcasting them. In addition, FDAAA 

provides that FDA may require the 

submission of drug television 

advertisements for review before 

dissemination. However, this provision 

does not take effect until 180 days after 

FDAAA’s enactment, and does not affect 

this user fee program, which only 

applies to voluntary submissions for 

advisory review. 

As FDA’s DTC advisory review 

workload has grown, FDA’s ability to 

keep pace with the demands for reviews 

has decreased, and the time it takes to 

review DTC materials submitted for 

advisory review, including television 

advertisements, has been increasing. 

The lack of timely, predictable FDA 

review times for DTC television 

advertisements has hindered 

companies’ ability to accurately set 

timeframes for their marketing 

campaigns and has discouraged 

companies from taking advantage of the 

DTC advisory review process. 

III. DTC User Fee Program 

The DTC user fee program is available 

to companies interested in voluntarily 

submitting to FDA for advisory review 

a DTC television advertisement for any 

product that qualifies as a ‘‘prescription 

drug product,’’ as defined in 21 U.S.C. 

379g(3). Under this program, a company 

that chooses to submit a DTC television 

advertisement for advisory review will 

be assessed two types of fees: (1) A fee 

for each proposed DTC television 

advertisement submitted for advisory 

review prior to its initial public 

dissemination (‘‘advisory review fee’’) 

and (2) a fee paid during the company’s 

first year of participation in the program 

to establish a reserve fund (‘‘operating 

reserve fee’’). 

The decision to seek an advisory 

review from FDA remains voluntary. 

However, FDA will not accept for 

review any prescription drug DTC 

television advertisements voluntarily 

submitted by a company for advisory 

review unless the company has paid 

both fees. 

The payment of an advisory review 

fee under new section 736A of the act 

entitles a company to submit for 

advisory review by FDA one proposed 

predissemination DTC television 

advertisement, and one resubmission of 

the same proposed DTC television 

advertisement, after receipt of FDA 

advisory comments on the initial 

submission. It should be noted that fees 

will not be assessed for advertisements 

required to be submitted to FDA prior 

to initial public dissemination, such as 

advertisements for accelerated approval 

drugs (21 CFR 314.550 and 314.640 

(subparts H and I)), biologics (21 CFR 

601.45 and 601.94 (subparts E and H)), 

and submissions required by the 

Secretary under section 901 of FDAAA 

(as it amends the act to add section 

503B, ‘‘Prereview of Television 

Advertisements’’), unless the sponsor 

voluntarily designates the required 

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Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 60679 

submission as a submission for advisory 

review under this program. Fees also 

will not be assessed for advisory 

reviews of advertising or promotional 

material other than DTC television 

advertisements (e.g., print 

advertisements or promotional labeling). 

The user fees associated with this 

program are structured to provide 

incentives for companies to join the 

program in FY 2008 and to pay all fees 

on time, as this will give FDA the 

funding it needs to hire sufficient staff 

to review the identified number of 

advisory submissions in FY 2008. FDA 

will recruit staff to conduct reviews 

based upon the expected number of 

submissions for FY 2008 that are 

identified in response to this 

participation notice. Fees for FY 2008 

must be paid in a timely manner to 

allow FDA to actually obtain these 

staffing resources to conduct timely 

reviews and meet performance metrics 

during this year. In addition, the 

program contains incentives for timely 

participation and payment. Participants 

who do not pay their fees on time or 

who join the program late in a fiscal 

year must pay individual fees that are 

50 percent greater than the established 

individual fees for participants who 

both join the program and pay on time. 

IV. Establishing the Advisory Review 

Fee 

A. Process 

Congress directed FDA to issue a 

Federal Register notice, not later than 

30 days after enactment of FDAAA, 

asking companies to indicate whether 

they intend to participate in the DTC 

user fee program by voluntarily 

submitting for FDA advisory review 

DTC television advertisements for 

prescription drugs during FY 2008. 

Companies that indicate they intend to 

participate must specify the number of 

advertisements they intend to submit in 

FY 2008. Once companies have 

responded to this notice, FDA will issue 

another Federal Register notice 

establishing the fee for each advisory 

review submission for FY 2008. 

B. Basis for the Fee 

The fee will be based on the number 

of advertisements identified in response 

to this participation notice. The 

advisory review fees in FY 2008 will be 

set at a level to generate target revenues 

of $6.25 million in the first year of the 

program. Individual fees will be 

determined by dividing the target 

revenue, established in the statute, by 

the number of proposed television 

advertisements that all companies have 

indicated (in response to the 

participation notice) that they intend to 

submit during FY 2008. For example, if 

companies indicate that they intend to 

submit 150 total advertisements, the fee 

for each advisory review submission 

will be $41,667 ($6.25 million divided 

by 150). The statute limits this fee to no 

more than $83,000 per submission for 

FY 2008. This limitation is one of 

several provisions in the statute that 

help ensure individual sponsors will 

not individually bear a disproportionate 

share of the cost of the program. The 

target revenue figures will be adjusted 

annually for inflation and workload in 

subsequent years. In each subsequent 

fiscal year of the program, FDA will 

issue a new request for notice of 

participation by June 1 of the previous 

fiscal year and a second notice by 

August 1 of the previous fiscal year 

establishing the fees for the fiscal year 

beginning October 1. 

C. Additional Submissions 

If, in response to this notice, a 

participant notifies FDA that it plans to 

submit a certain number of 

advertisements for FY 2008 and then 

exceeds that number of advertisements, 

the participant will be assessed a fee for 

each additional submission. The fee will 

be 50 percent greater than the 

established individual fee. In addition, 

a participant who does not pay the fees 

for which it is billed within the 

timeframe specified by the Secretary 

once the fees are set for FY 2008 will be 

assessed a penalty that is 50 percent 

greater than the established individual 

fee. 

D. Year-to-Year Carry Overs 

If a company identifies and pays for 

more advisory reviews than it submits 

in a given fiscal year, the company may 

carry over one paid submission for 

advisory review to the next fiscal year. 

This means that a submission for 

advisory review for which the fee was 

paid in 1 fiscal year can be submitted 

for advisory review in the following 

fiscal year. Companies cannot carry over 

more than one such submission to the 

next fiscal year; for unused submissions 

over and above the one available for 

carryover, the paid user fee will not be 

refunded, waived, exempted, or 

reduced. However, resubmissions are 

not subject to a fiscal year limitation. 

For example, a company can submit an 

advertisement for advisory review in 

fiscal year 2008 and resubmit a revised 

version of that same advertisement for 

advisory review in fiscal year 2009, at 

no additional cost. 

E. Operating Reserves 

To establish operating reserves for the 

program, in the first year of their 

participation in the program, 

participants will be assessed a one-time 

participation fee that will be based on 

the number of anticipated submissions 

the participant identifies for that year. 

In this way, FDA will collect additional 

revenues of $6.25 million to be placed 

in reserve from which funds can be 

drawn if target revenues fluctuate 

downward in subsequent years. For 

companies responding by November 26, 

2007, the operating reserve fee for each 

participant in FY 2008 will be an 

amount equal to the total amount that 

company is charged for its annual 

advisory review fees for FY 2008. For 

companies who respond by November 

26, 2007, but do not pay the assessed 

operating reserve fee within the 

timeframe specified by the Secretary, 

their operating reserve fee will be 50 

percent higher than what they would 

have owed had they paid on time. For 

participants who join the program late 

in FY 2008, i.e., those who do not notify 

FDA of their intent to participate until 

after November 26, 2007, the operating 

reserve fee will be 50 percent higher 

than what they would have owed had 

they both notified FDA and paid on 

time. Companies who join the program 

in subsequent fiscal years (FYs 2009 to 

2012) will be assessed an amount for the 

operating reserve fee that will be at least 

as much as the amount they would have 

been assessed if they had joined the 

program at the start of FY 2008. 

Specifically, in subsequent years, the 

operating reserve fee for new 

participants will be the higher of: (1) 

The total amount of advisory review 

fees for all of the new participant’s 

proposed DTC television advertisements 

in the fiscal year they join the program 

or (2) the total amount of advisory 

review fees that would have been 

assessed in FY 2008 for that number of 

proposed DTC television 

advertisements. This statutory fee 

structure limits the incentive for 

companies to join the program late, 

which could prevent the program from 

receiving sufficient funding in the 

initial year and place a disproportionate 

share of the cost of the program on those 

participants who join the program in its 

initial year of operation. 

F. Effect of Inadequate Funding 

The statute provides that if FDA fails 

to receive sufficient funding from 

companies within 120 days after 

enactment of FDAAA, the program will 

not commence. Sufficient funding 

consists of a combined total amount of 

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60680 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 

at least $11.25 million from advisory 

review fees and operating reserve fees. 

In the event that insufficient funding is 

received and the program does not 

commence, all collected fees will be 

refunded to the companies that paid. 

G. FDA Commitment 

The fees will be used to fund 

approximately 27 additional staff for 

predissemination advisory review of 

DTC television advertisements. These 

additional resources will enable FDA to 

provide more timely reviews of DTC 

television advertisements. FDA has 

committed to phased-in performance 

metrics. For example, assuming 150 

submissions in FY 2008, FDA will 

review and provide advisory comments 

to the sponsor within 45 days on 50 

percent of the 150 original submissions. 

In addition, FDA is committed to 

reviewing 50 percent of resubmissions 

within 30 days. The performance 

metrics will be phased in over the 5 

years of the program, with each year 

including more stringent performance 

goals. 

V. Request for Notice of Participation 

FDA is asking companies that intend 

to submit advertisements to FDA for 

advisory review in FY 2008 to notify 

FDA by November 26, 2007 of: (1) Their 

intent to submit advertisements for 

advisory review and (2) the number of 

DTC television advertisements they plan 

to submit for advisory review during FY 

2008. 

Notification of participation without 

specifying the number of DTC television 

advertisements to be submitted in FY 

2008 will be considered an incomplete 

notification, and subsequent notification 

of intent to submit advertisements after 

November 26, 2007 would be treated as 

late. 

The agency requests that all 

companies submit their written 

responses within 30 calendar days (see 

DATES) by overnight courier service to 

Wayne Amchin (see ADDRESSES) and fax 

or e-mail a copy of their response (see 

ADDRESSES). 

A. What Should Those Wishing To 

Participate Submit in Their Written 

Notification? 

The following information should be 

included in a company’s DTC television 

advertisement written notification: 

• A statement that they will submit 

DTC television advertisements to FDA 

for advisory review during FY 2008, 

• The number of proposed DTC 

television advertisements they will 

submit for advisory review under the 

DTC user fee program in FY 2008, and 

• The name, title, billing address, and 

contact information (phone, e-mail, fax) 

of the company representative who will 

be the primary person for FDA to 

contact concerning the company’s 

participation in the program. 

B. What Does Written Notification to 

FDA Mean? 

Each company’s written notification 

to FDA of the number of DTC television 

advertisements it intends to submit for 

advisory review in FY 2008 is a legally 

binding commitment by that company 

to pay the FY 2008 advisory review fee 

for each submission (see section 

736A(a)(1)(D)(ii) of the act). Each person 

who is assessed an advisory review fee 

is also required to pay an operating 

reserve fee for those submissions (a onetime fee in the first year of participation 

to fund the operating reserve) (see 

section 736A(a)(2) of the act). FDA will 

send invoices to each company for all 

submissions identified in response to 

this notice, and the advisory review fee 

and the operating reserve fee for all 

these submissions are due and payable 

on the date specified in the invoices. 

FDA will also assign each participant a 

series of unique user fee ID numbers to 

correspond with the number of advisory 

reviews that the participant identified in 

response to this notice. For example, a 

company identifying 10 advisory 

reviews will receive 10 unique user fee 

ID numbers in its invoice. Each 

submission of a DTC television 

advertisement for FDA advisory review 

will be identified with a user fee ID 

number to show that the fee has been 

paid. A company’s request for advisory 

review will be considered incomplete 

and submissions will not be accepted 

for review until all fees owed by the 

company for all advisory reviews and 

the operating reserve fee have been paid 

(see section 736A(e) of the act). 

C. Can a Company Transfer or Sell its 

Remaining Balance of User Fee Credits 

to Another Company? 

For each advisory review fee paid by 

a person for a fiscal year, section 

736A(a)(1)(F)(i) of the act provides that 

the person is entitled to acceptance for 

advisory review of one DTC 

advertisement and acceptance of one 

resubmission for advisory review of the 

same advertisement. Section 

736A(a)(1)(F)(i) of the act further 

provides that the advertisement shall be 

submitted for review in the fiscal year 

for which the fee was assessed, except 

that a person may carry over not more 

than one paid advisory review 

submission to the next fiscal year. FDA 

will administratively keep track of these 

submissions as advisory review credits. 

Each credit for an advisory review will 

expire at the end of the fiscal year for 

which the user fees were paid, except 

that one unused credit can be carried 

over from the fiscal year in which it was 

purchased to the next fiscal year. 

Advisory review credits are not 

transferable, except to a successor in 

interest (see section 736A(a)(1)(F)(iv) of 

the act). If unexpired credits are 

transferred to a successor in interest, the 

successor company and former owner 

should notify FDA to ensure that future 

billing of the successor company reflects 

prior contributions to the DTC user fee 

program reserve fund and the unexpired 

credit balance. Evidence of a successor 

in interest could include a copy of the 

documentation required under 21 CFR 

314.72. Please contact Wayne Amchin 

(see FOR INFORMATION CONTACT) 

concerning successor in interest issues. 

Successors in interest with an 

unexpired credit balance should also be 

aware of the following: 

• One unused credit can be carried 

over from the fiscal year in which it was 

purchased to the next fiscal year. 

• In responding to the annual Federal 

Register notice for company 

participation, the successor company 

must indicate its intent to use the 

unexpired carryover credit in the 

upcoming fiscal year. 

D. How Do I Send in DTC Television 

Advertisements for Advisory Review 

Under the DTC User Fee Program? 

FDA intends to issue guidance to 

industry explaining how to submit DTC 

advisory review packages for review 

under the DTC user fee program. The 

guidance document will provide details 

on the contents, format, and procedures 

that FDA recommends be followed. The 

guidance will also explain how and 

where to submit advisory review 

packages to start the DTC user fee 

program performance clock. FDA will 

issue a Federal Register notice to 

announce the availability of this 

guidance. 

E. What Happens if I Send in a DTC 

Television Advertisement for Advisory 

Review After October 1, 2007, but Before 

I’m Invoiced by FDA for My FY 2008 

Fees? 

The effective date for the assessment 

and collection of fees for DTC television 

advertisements under this program is 

October 1, 2007. Therefore, any DTC 

television advertisement submitted for 

advisory review in FY 2008 is subject to 

the previously discussed fees under this 

program. FDA recognizes that, because 

of the timing of the enactment of 

FDAAA, the advisory review and 

operating reserve fees for FY 2008 were 

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Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 60681 

not established and billed before 

October 1, 2007, and that there will be 

a gap between the start of the fiscal year 

and the date that fees are due. However, 

the voluntary submission of a DTC 

television advertisement for FDA 

advisory review on or after October 1, 

2007, but before November 26, 2007 will 

be considered by FDA as notification 

that the company who submitted the 

advertisement wishes to participate in 

the program and agrees to pay the 

advisory review fee and operating 

reserve fee for each such submission in 

a timely manner once the fees for FY 

2008 are established and the company is 

invoiced. Companies who submit DTC 

television advertisements for advisory 

review in this period should respond to 

this participation notice, and include 

any such submissions in their count of 

the total number of advisory 

submissions they intend to submit in FY 

2008. FDA will also contact companies 

who submit DTC television 

advertisements in this time period to 

request written confirmation from these 

companies of their commitment to pay 

these fees; if companies do not agree to 

make this commitment, FDA will 

request that they withdraw their 

submission(s), and such submissions 

will not be reviewed. For companies 

who do agree, FDA will begin its 

advisory review of a complete 

submission of a DTC television 

advertisement for advisory review on 

the date that it receives written 

confirmation of the company’s 

commitment to pay the fees associated 

with the submission in a timely manner 

once the company is invoiced. 

For information on how FDA will 

treat DTC television advertisement 

advisory review submissions not 

identified in response to this notice that 

are submitted after November 26, 2007, 

see sections IV.C ‘‘Additional 

Submissions’’ and IV.E ‘‘Operating 

Reserves’’ of this document. 

Dated: October 19, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5282 Filed 10–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Immune Correlates of Protection 

Against Influenza A Viruses in Support 

of Pandemic Vaccine Development; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘ Immune Correlates of 

Protection against Influenza A Viruses 

in Support of Pandemic Vaccine 

Development.’’ The purpose of the 

public workshop is to identify the gaps 

in our knowledge and abilities in 

addressing the unique challenges 

encountered in the development and 

evaluation of vaccines intended to 

protect against pandemic influenza. 

Date and Time: The public workshop 

will be held on December 10, 2007, from 

8:30 a.m. to 5:30 p.m. and December 11, 

2007, from 8 a.m. to 5:15 p.m. 

Location: The public workshop will 

be held at the Hyatt Regency Bethesda, 

One Bethesda Metro Center, Bethesda, 

MD 20814. For directions, see the hotel 

Web site at: http:// 

www.bethesda.hyatt.com or call the 

hotel at 301–657–1234. 

Contact Person: Maureen Hess, Center 

for Biologics Evaluation and Research 

(HFM–405), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852, 301–827–5113, 

FAX: 301–827–9781, e-mail: 

maureen.hess@fda.hhs.gov. 

Registration: E-mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone, fax number and e-mail 

address) to the contact person by 

November 19, 2007. There is no 

registration fee for the public workshop. 

Early registration is recommended 

because seating is limited. There will be 

no onsite registration. 

If you need special accommodations 

due to a disability, please contact Ms. 

Maureen Hess (see Contact Person) at 

least 7 days in advance. 

SUPPLEMENTARY INFORMATION: FDA’s 

Center for Biologics Evaluation and 

Research, in cooperation with the 

National Institutes of Health’s Division 

of Intramural Research within the 

National Institute of Allergy and 

Infectious Diseases and the World 

Health Organization, is holding this 

public workshop. The public workshop 

will include discussions on: (1) Current 

knowledge regarding correlates of 

protection against seasonal influenza, 

(2) immune responses to avian influenza 

infections and vaccines for novel 

influenza viruses in humans, (3) assays 

to evaluate vaccine immunogenicity, 

and (4) evaluation of avian influenza 

vaccine efficacy. The goals of the public 

workshop are to: (1) Identify the gaps in 

our knowledge and abilities in 

addressing the unique challenges 

encountered in the development and 

evaluation of vaccines intended to 

protect against pandemic influenza, and 

(2) facilitate implementation of a global 

research agenda to improve efficacy 

assessment of pandemic influenza 

vaccines. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet at http://www.fda.gov/cber/ 

minutes/workshop-min.htm. 

Dated: October 18, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–20981 Filed 10–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0396] 

Draft Guidance for Industry on DrugInduced Liver Injury: Premarketing 

Clinical Evaluation; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Drug-Induced Liver 

Injury: Premarketing Clinical 

Evaluation.’’ This guidance is intended 

to assist the pharmaceutical industry 

and others engaged in new drug 

development in the assessment of the 

potential of a drug to cause severe druginduced liver injury (DILI). This 

guidance defines severe DILI as injury 

that is fatal or requires liver 

transplantation. This guidance does not 

address the postmarketing evaluation of 

DILI. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by December 24, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

mstockstill on PROD1PC66 with NOTICES