Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45867 

polypeptide capsule of poly-g-Dglutamic acid (gDPGA). gDPGA is poorly 

immunogenic and has antiphagocytic 

properties. The bacterial capsule is 

essential for virulence. Antibodies to the 

capsule have been shown to enhance 

phagocytosis and killing of 

encapsulated bacilli. These antibodies 

in combination with antibodies that 

neutralize the toxins of B. anthracis 

could provide enhanced protection by 

their dual antibacterial and antitoxic 

activities. Such antibodies would be 

especially useful for antibiotic-resistant 

strains. 

In order to obtain therapeutically 

useful anti-g DPGA monoclonal 

antibodies (MAbs), the inventors 

immunized chimpanzees with 

conjugates of 15-mer glutamic acid 

polymers to immunogenic protein 

carriers (recombinant protective antigen 

(PA) of B. anthracis). After several 

immunizations, chimpanzees developed 

strong immune responses to gDPGA. A 

combinatorial Fab library of mRNA 

derived from the chimpanzee’s bone 

marrow was prepared and eight (8) 

distinct Fabs reactive with native 

gDPGA were recovered. Two (2) of the 

Fabs were converted into full-length IgG 

with human g1 heavy chain constant 

regions. These two (2) MAbs showed 

strong opsonophagocytic killing of 

bacilli in an in vitro assay. These two (2) 

MAbs were also tested for protection of 

mice challenged with virulent anthrax 

spores and results showed that both 

MAbs provided full or nearly full 

protection at a dose of 0.3 mg, the 

lowest dose tested, which is much more 

potent than previously reported murine 

anti-PGA MAbs. Since chimpanzee 

immunoglobulins are virtually identical 

to human immunoglobulins, these 

chimpanzee anticapsule MAbs may 

have clinically useful applications. 

This application claims the antibody 

compositions described above. Also 

claimed are methods of treating or 

preventing B. anthracis infection in a 

mammalian host and isolated 

polynucleotides comprising a 

nucleotide sequence encoding the 

antibodies of the technology. 

Applications: Development of anthrax 

vaccines, therapeutics and diagnostics. 

Advantages: Strongly neutralizing 

antibodies, known regulatory pathway, 

potential for use as both a prophylaxis 

and therapy. 

Development Status: Preclinical 

studies have been performed utilizing 

the monoclonal antibodies of this 

technology. 

Inventors: Zhaochun Chen (NIAID), 

Robert H. Purcell (NIAID), Joanna 

Kubler-Kielb (NICHD), Lily Zhongdong 

Dai (NICHD), Rachel Schneerson 

(NICHD). 

Patent Status: U.S. Provisional 

Application No. 61/116,222 filed 19 

Nov 2008 (HHS Reference No. E–125– 

2008/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize MAbs neutralizing 

anthrax toxins and capsule for 

comprehensive protection against 

anthrax. Please contact Bill Ronnenberg, 

NIAID Office of Technology 

Development, at 301–451–3522 for more 

information. 

Dated: August 28, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–21482 Filed 9–3–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Health 

Promotion and Disease Prevention 

Research Centers, Special Interest 

Project Competitive Supplements 

(SIPS) (U48 Panels A–M), RFA–DP09– 

101SUPP09, Initial Review 

Cancellation: The notice was 

originally published in the Federal 

Register on July 14, 2009 (Volume 74, 

Number 133) [page 34026]. The 

following panels are cancelled: D, F, K, 

L and M. 

Contact Person for More Information: 

Brenda Colley-Gilbert, PhD, Director, 

Extramural Research Program Office, 

CCCH, 4770 Buford Highway, MS K–92, 

Atlanta, GA 30341, Telephone (770) 

488–6295. 

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 CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: August 26, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–21379 Filed 9–3–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0233] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: Under the Food and Drug 

Administration Modernization Act of 

1997 (Modernization Act), the Food and 

Drug Administration (FDA) is required 

to report annually in the Federal 

Register on the status of postmarketing 

requirements and commitments 

required of, or agreed upon, by holders 

of approved drug and biological 

products. This is the agency’s report on 

the status of the studies and clinical 

trials that applicants have agreed to or 

are required to conduct. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn C. Lee, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6464, 

Silver Spring, MD 20993–0002, 

301–796–0700; or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1400 Rockville Pike, Rockville, MD 

20852, 301–827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Modernization Act 

Section 130(a) of the Modernization 

Act (Public Law 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding a new provision 

requiring reports of certain 

postmarketing studies, including 

clinical trials, for human drug and 

biological products (section 506B of the 

act (21 U.S.C. 356(b)). Section 506B of 

the act provides FDA with additional 

authority to monitor the progress of a 

postmarketing study or clinical trial that 

an applicant has been required to or has 

agreed to conduct by requiring the 

applicant to submit a report annually 


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45868 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

1FDA could require postmarketing studies and 

clinical trials under the following circumstances: 

To verify and describe clinical benefit for a human 

drug approved in accordance with the accelerated 

approval provisions (21 U.S.C. 356(b)(2)(A); 21 CFR 

314.510 and 601.41); for a drug approved on the 

basis of animal efficacy data because human 

efficacy trials are not ethical or feasible (21 CFR 

314.610(b)(1) and 601.91(b)(1)); and for marketed 

drugs that are not adequately labeled for children 

(Pediatric Research Equity Act (21 U.S.C. 355B; 

Public Law 108–155)). 

providing information on the status of 

the postmarketing study/clinical trial. 

This report must also include reasons, if 

any, for failure to complete the study/ 

clinical trial. These studies and clinical 

trials are intended to further define the 

safety, efficacy, or optimal use of a 

product and therefore play a vital role 

in fully characterizing the product. 

Under the Modernization Act, 

commitments to conduct postmarketing 

studies or clinical trials included both 

studies/clinical trials that applicants 

agreed to conduct as well as studies/ 

clinical trials that applicants were 

required to conduct under FDA 

regulations.1

B. The Food and Drug Administration 

Amendments Act of 2007 

On September 27, 2007, the President 

signed Public Law 110–85, the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA). Section 901, in Title 

IX of FDAAA, created a new section 

505(o) of the act authorizing FDA to 

require certain studies and clinical trials 

for human drug and biological products 

approved under section 505 of the act or 

section 351 of the Public Health Service 

Act. Under FDAAA, FDA has been 

given additional authority to require 

applicants to conduct and report on 

postmarketing studies and clinical trials 

to assess a known serious risk, assess 

signals of serious risk, or identify an 

unexpected serious risk related to the 

use of a product. This new authority 

became effective on March 25, 2008. 

FDA may now take enforcement action 

against applicants who fail to conduct 

studies and clinical trials required 

under FDAAA, as well as studies and 

clinical trials required under FDA 

regulations (see sections 505(o)(1), 

502(z), and 303(f) of the act; 21 U.S.C. 

355(o)(1), 352(z), and 333(f)). 

Although regulations implementing 

the Modernization Act postmarketing 

authorities use the term ‘‘postmarketing 

commitment’’ to refer to both required 

studies and studies applicants agree to 

conduct, in light of the new authorities 

enacted in FDAAA, FDA has decided it 

is important to distinguish between 

enforceable postmarketing requirements 

and unenforceable postmarketing 

commitments. Therefore, in this notice 

and report, FDA refers to studies/ 

clinical trials that an applicant is 

required to conduct as ‘‘postmarketing 

requirements’’ (PMRs) and studies/ 

clinical trials that an applicant agrees to 

but is not required to conduct as 

‘‘postmarketing commitments’’ (PMCs). 

Both are addressed in this notice and 

report. 

C. FDA’s Implementing Regulations 

On October 30, 2000 (65 FR 64607), 

FDA published a final rule 

implementing section 130 of the 

Modernization Act. This rule modified 

the annual report requirements for new 

drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs) by revising § 314.81(b)(2)(vii) 

(21 CFR 314.81(b)(2)(vii)). The rule also 

created a new annual reporting 

requirement for biologics license 

applications (BLAs) by establishing 

§ 601.70 (21 CFR 601.70). The rule 

described the content and format of the 

annual progress report, and clarified the 

scope of the reporting requirement and 

the timing for submission of the annual 

progress reports. The rule became 

effective on April 30, 2001. The 

regulations apply only to human drug 

and biological products that are 

approved under NDAs, ANDAs, and 

BLAs. They do not apply to animal 

drugs or to biological products regulated 

under the medical device authorities. 

The reporting requirements under 

§§ 314.81(b)(2)(vii) and 601.70 apply to 

PMRs and PMCs made on or before the 

enactment of the Modernization Act 

(November 21, 1997), as well as those 

made after that date. Therefore, studies 

and clinical trials required under 

FDAAA are covered by the reporting 

requirements in these regulations. 

Sections 314.81(b)(2)(vii) and 601.70 

require applicants of approved drug and 

biological products to submit annually a 

report on the status of each clinical 

safety, clinical efficacy, clinical 

pharmacology, and nonclinical 

toxicology study/clinical trial that is 

required by FDA or that they have 

committed to conduct either at the time 

of approval or after approval of their 

NDA, ANDA, or BLA. The status of 

PMCs concerning chemistry, 

manufacturing, and production controls 

and the status of other studies/clinical 

trials conducted on an applicant’s own 

initiative are not required to be reported 

under §§ 314.81(b)(2)(vii) and 601.70 

and are not addressed in this report. It 

should be noted, however, that 

applicants are required to report to FDA 

on these commitments made for NDAs 

and ANDAs under § 314.81(b)(2)(viii). 

Furthermore, section 505(o)(1)(E) of the 

act as amended by FDAAA requires that 

applicants report periodically on the 

status of each required study/clinical 

trial and each study/clinical trial 

‘‘otherwise undertaken * * * to 

investigate a safety issue * * * .’’ 

According to the regulations, once a 

PMR has been required or a PMC has 

been agreed upon, an applicant must 

report on the progress of the PMR/PMC 

on the anniversary of the product’s 

approval until the PMR/PMC is 

completed or terminated and FDA 

determines that the PMR/PMC has been 

fulfilled or that the PMR/PMC is either 

no longer feasible or would no longer 

provide useful information. The annual 

progress report must include a 

description of the PMR/PMC, a schedule 

for completing the PMR/PMC, and a 

characterization of the current status of 

the PMR/PMC. The report must also 

provide an explanation of the PMR/PMC 

status by describing briefly the progress 

of the PMR/PMC. A PMR/PMC schedule 

is expected to include the actual or 

projected dates for the following: (1) 

Submission of the final protocol to FDA, 

(2) completion of subject accrual or 

initiation of an animal study, (3) 

completion of the study/clinical trial, 

and (4) submission of the final report to 

FDA. The status of the PMR/PMC must 

be described in the annual report 

according to the following definitions: 

• Pending: The study/clinical trial 

has not been initiated (i.e., no subjects 

have been enrolled or animals dosed), 

but does not meet the criteria for 

delayed (i.e., the original projected date 

for initiation of subject accrual or 

initiation of animal dosing has not 

passed); 

• Ongoing: The study/clinical trial is 

proceeding according to or ahead of the 

original schedule; 

• Delayed: The study/clinical trial is 

behind the original schedule; 

• Terminated: The study/clinical trial 

was ended before completion, but a 

final report has not been submitted to 

FDA; or 

• Submitted: The study/clinical trial 

has been completed or terminated, and 

a final report has been submitted to 

FDA. 

Databases containing information on 

PMRs/PMCs are maintained at the 

Center for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER). 

II. Summary of Information From 

Postmarketing Status Reports 

This report, published to fulfill the 

annual reporting requirement under the 

Modernization Act, summarizes the 

status of PMRs and PMCs as of 

September 30, 2008. If a requirement or 

commitment did not have a schedule, or 


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Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45869 

2Although there are PMCs that might meet 

FDAAA standards for required safety studies/ 

clinical trials under section 505(o)(3)(B) of the act 

(21 U.S.C. 355(o)(3)(B)) if they were first 

determined to be necessary today, they may be 

converted to PMRs only if FDA becomes aware of 

new safety information. 

3The external backlog review covered PMRs/ 

PMCs for NDAs and CDER-regulated BLAs. CBER 

conducted a separate backlog review of the CBERregulated BLAs. 

a postmarketing progress report was not 

received in the previous 12 months, the 

PMR/PMC is categorized according to 

the most recent information available to 

the agency. 

Information in this report covers any 

PMR/PMC that was made, in writing, at 

the time of approval or after approval of 

an application or a supplement to an 

application, including PMRs required 

under FDAAA (section 505(o)(3) of the 

act), PMRs required under FDA 

regulations (e.g., PMRs required to 

demonstrate clinical benefit of a product 

following accelerated approval (see 

footnote 1 of this document)), and PMCs 

agreed to by the applicant. 

Information summarized in this report 

includes the following: (1) The number 

of applicants with open (uncompleted) 

PMRs/PMCs, (2) the number of open 

PMRs/PMCs, (3) the status of open 

PMRs/PMCs as reported in 

§ 314.81(b)(2)(vii) or § 601.70 annual 

reports, (4) the status of concluded 

PMRs/PMCs as determined by FDA, and 

(5) the number of applications with 

open PMRs/PMCs for which applicants 

did not submit an annual report within 

60 days of the anniversary date of U.S. 

approval. 

Additional information about PMRs/ 

PMCs submitted by applicants to CDER 

and CBER is provided on FDA’s Web 

site at http://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Post-marketingPhaseIV

Commitments/default.htm. Neither the 

Web site nor this notice include 

information about PMCs concerning 

chemistry, manufacturing, and controls. 

It is FDA policy not to post information 

on the Web site until it has been 

reviewed for accuracy. Numbers 

published in this notice cannot be 

compared with the numbers resulting 

from searches of the Web site because 

this notice incorporates totals for all 

PMRs/PMCs in FDA databases, 

including PMRs/PMCs undergoing 

review for accuracy. In addition, the 

report in this notice will be updated 

annually while the Web site is updated 

quarterly (i.e., January, April, July, and 

October). 

Many applicants have more than one 

approved product and for many 

products there is more than one PMR or 

PMC. Specifically, there were 158 

unique applicants with 297 NDAs/ 

ANDAs that had open PMRs/PMCs. 

There were 54 unique applicants with 

94 BLAs that had open PMRs/PMCs. 

Annual status reports are required to 

be submitted for each open PMR/PMC 

within 60 days of the anniversary date 

of U.S. approval of the original 

application. In fiscal year (FY) 2008, 27 

percent (59/215) of NDA/ANDA and 52 

percent (43/83) of BLA annual status 

reports were reported late or were 

overdue at the close of the FY, 

September 30, 2008. Of the annual 

status reports due but not submitted 

within 60 days of the anniversary date 

of U.S. approval of the original 

application, 100 percent (59/59) of the 

NDA/ANDA and 42 percent (18/43) of 

the BLA reports were submitted before 

September 30, 2008. 

Most PMRs are progressing on 

schedule (95 percent for NDAs/ANDAs; 

89 percent for BLAs). Most PMCs are 

also progressing on schedule (96 percent 

for NDAs/ANDAs; 78 percent for BLAs). 

Most of the PMCs that are currently 

listed in the database were developed 

before the postmarketing requirements 

section of FDAAA took effect.2

III. What’s New About This Report 

This report now provides six separate 

tables instead of one summary table. 

The tables distinguish between PMRs 

and PMCs and between on-schedule and 

off-schedule PMRs and PMCs according 

to the original schedule milestones. Onschedule PMRs/PMCs are categorized as 

pending, ongoing, or submitted. Offschedule PMRs/PMCs that have missed 

one of the original milestone dates are 

categorized as delayed or terminated. 

The tables include data as of September 

30, 2008. 

Table 1 of this document provides an 

overall summary of the data on all PMRs 

and PMCs. Tables 2 and 3 of this 

document provide detail on PMRs. 

Table 2 of this document provides 

additional detail on the status of onschedule PMRs. 

Table 1 of this document shows that 

most PMRs (95 percent for NDAs/ 

ANDAs and 89 percent for BLAs) and 

most PMCs (96 percent for NDAs/ 

ANDAs and 78 percent for BLAs) are on 

schedule. Overall, of the PMRs that are 

pending (i.e., have not been initiated), 

73 percent were created within the past 

3 years. 

Table 2 of this document shows that 

most pending PMRs for both drug and 

biological products are in response to 

the Pediatric Research and Equity Act 

(PREA), under which FDA requires 

sponsors to study new drugs, when 

appropriate, for pediatric populations. 

Under section 505B(a)(3) of the act, the 

initiation of these studies generally is 

deferred until required safety 

information from other studies has first 

been submitted and reviewed. PMRs for 

products approved under the animal 

efficacy rule (21 CFR 314.600 for drugs; 

21 CFR 601.90 for biological products) 

can be conducted only when the 

product is used for its indication as a 

counterterrorism measure. In the 

absence of a public health emergency, 

these studies/clinical trials will remain 

pending indefinitely. The next largest 

category of pending PMRs comprises 

those studies/clinical trials required by 

FDA under FDAAA, which became 

effective on March 25, 2008. 

Section 921 of FDAAA requires FDA 

to review the backlog of postmarketing 

safety commitments and report to 

Congress. CDER contracted with an 

external group to review the backlog of 

its PMRs/PMCs as well as PMR/PMC 

annual status reports.3 The contractors’s 

report was recently completed and can 

be found on the FDA Web site at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/PostmarketingPhaseIVCommitments/ 

ucm064436.htm. As Exhibit 9 of the 

report shows, the external review has 

resulted in a decreased number of NDA 

PMRs/PMCs categorized as pending 

because their statuses have been 

updated to other categories (e.g., 

submitted). Some of this decrease is 

reflected in the NDA statistics reported 

in this notice, which shows the status of 

the PMRs/PMCs as of September 30, 

2008, and additional status changes will 

be reflected in the statistics reported in 

the next annual notice showing the 

status of the PMRs/PMCs as of 

September 30, 2009. 


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Table 3 of this document provides 

additional detail on the status of offschedule PMRs. The majority of offschedule PMRs (which account for only 

5 percent of the total for NDAs/ANDAs 

and 11 percent for BLAs) are delayed 

according to the original schedule 

milestones (93 percent (13/14) for 

NDAs/ANDAs; 71 percent (5/7) for 

BLAs). However, after discussion 

between FDA and applicants, the 

original schedules may have been 

adjusted for unanticipated delays in the 

progress of the study/clinical trial (e.g., 

difficulties with subject enrollment in a 

trial for a marketed drug or need for 

additional time to analyze results). In 

this report, study status reflects the 

status in relation to the original study 

schedule regardless of whether 

adjustments to the schedule have been 

made. 

Tables 4 and 5 of this document 

provide additional detail on the status 

of PMCs. Table 4 provides additional 

detail on the status of on-schedule 

PMCs. Pending PMCs comprise 56 

percent (544/965) of the on-schedule 

NDA and ANDA PMCs and 40 percent 

(112/279) of the on-schedule BLA 

PMCs. 

Table 5 of this document provides 

additional details on the status of offschedule PMCs. The majority of offschedule PMCs (which account for only 

4 percent for NDAs/ANDAs and 22 

percent for BLAs) are delayed according 

to the original schedule milestones (91 

percent (39/43) for NDAs/ANDAs; 97 

percent (76/78) for BLAs). However, 

after discussion between FDA and 

applicants, the original schedules may 

have been adjusted for unanticipated 

delays in the progress of the study/ 

clinical trial (e.g., difficulties with 

subject enrollment in a trial for a 

marketed drug or need for additional 

time to analyze results). 

Table 6 of this document provides 

details about PMRs and PMCs that were 

concluded in the previous year. Most 

concluded PMRs and PMCs were 

fulfilled (80 percent of NDA/ANDA 

PMRs and 70 percent of BLA PMRs; 86 

percent of NDA/ANDA PMCs and 97 

percent of BLA PMCs). 

TABLE 1.—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2008) 

NDA/ANDA (% of Total PMR 

or % of Total PMC) 

BLA (% of Total PMR or % of 

Total PMC)1

Number of open PMRs 306 65 

On-schedule open PMRs (see table 2 of this document) 292 (95%) 58 (89%) 

Off-schedule open PMRs (see table 3 of this document) 14 (5%) 7 (11%) 

Number of open PMCs 1,008 357 

On-schedule open PMCs (see table 4 of this document) 965 (96%) 279 (78%) 

Off-schedule open PMCs (see table 5 of this document) 43 (4%) 78 (22%) 

1On October 1, 2003, FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently, 

CDER now reviews many BLAs. Fiscal year statistics for postmarketing requirements and commitments for BLAs reviewed by CDER are included in BLA totals in this table. 

TABLE 2.—SUMMARY OF ON-SCHEDULE POSTMARKETING REQUIREMENTS (NUMBERS AS OF SEPTEMBER 30, 2008) 

On-Schedule Open PMRs NDA/ANDA (% of Total PMR) BLA (% of Total PMR)1

Pending by type 

Accelerated approval 15 3 

PREA2 194 24 

Animal efficacy3 2 0 

FDAAA safety (since March 25, 2008) 30 12 

Total 241 (79%) 39 (60%) 

Ongoing 

Accelerated approval 17 3 

PREA2 13 6 

Animal efficacy3 0 0 

FDAAA safety (since March 25, 2008) 0 4 

Total 30 (10%) 13 (20%) 

Submitted 

Accelerated approval 12 2 

PREA2 9 4 


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Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45871 

TABLE 2.—SUMMARY OF ON-SCHEDULE POSTMARKETING REQUIREMENTS (NUMBERS AS OF SEPTEMBER 30, 2008)— 

Continued 

On-Schedule Open PMRs NDA/ANDA (% of Total PMR) BLA (% of Total PMR)1

Animal efficacy3 0 0 

FDAAA safety (since March 25, 2008) 0 0 

Total 21 (12%) 6 (9%) 

Combined Total 292 (95%) 58 (89%) 

1See note 1 for table 1 of this document. 

2 Many PREA studies have a pending status. PREA studies are usually deferred because the product is ready for approval in adults. Initiation 

of these studies also may be deferred until additional safety information from other studies has first been submitted and reviewed. 3PMRs for products approved under the animal efficacy rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) can be conducted only when the product is used for its indication as a counterterrorism measure. In the absence of a public health emergency, these studies/clinical trials will remain pending indefinitely. 

TABLE 3.—SUMMARY OF OFF-SCHEDULE POSTMARKETING REQUIREMENTS (NUMBERS AS OF SEPTEMBER 30, 2008) 

Off-Schedule Open PMRs NDA/ANDA (% of Total PMR) BLA (% of Total PMR)1

Delayed 

Accelerated approval 4 2 

PREA 9 3 

Animal efficacy 0 0 

FDAAA safety (since March 25, 2008) 0 0 

Total 13 (4%) 5 (8%) 

Terminated 1 (0.3%) 2 (3%) 

Combined total 14 (5%) 7 (11%) 

1See note 1 for table 1 of this document. 

TABLE 4.—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2008) 

On-Schedule Open PMCs NDA/ANDA (% of Total PMC) BLA (% of Total PMC)1

Pending 544 (54%) 112 (31%) 

Ongoing 166 (17%) 93 (26%) 

Submitted 255 (25%) 74 (21%) 

Combined total 965 (96%) 279 (78%) 

1See note 1 for table 1 of this document. 

TABLE 5.—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2008) 

Off-Schedule Open PMCs NDA/ANDA (% of Total PMC) BLA (% of Total PMC)1

Delayed 39 (4%) 76 (21%) 

Terminated 4 (0.4%) 2 (1%) 

Combined total 43 (4%) 78 (22%) 

1See note 1 for table 1 of this document. 

TABLE 6.—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS (OCTOBER 1, 2007 TO

OCTOBER 1, 2008) 

NDA/ANDA (% of Total) BLA (% of Total)1

Concluded PMRs 

Requirement met (fulfilled) 12 (80%) 7 (70%) 


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TABLE 6.—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS (OCTOBER 1, 2007 TO

OCTOBER 1, 2008)—Continued 

NDA/ANDA (% of Total) BLA (% of Total)1

Requirement not met (released and new revised requirement issued) 1 (7%) 0 

Requirement no longer feasible or product withdrawn (released) 2 (13%) 3 (30%) 

Total 15 10 

Concluded PMCs 

Commitment met (fulfilled) 94 (86%) 30 (97%) 

Commitment not met (released and new revised requirement/commitment 

issued) 3 (3%) 0 

Commitment no longer feasible or product withdrawn (released) 12 (11%) 1 (3%) 

Total 109 31 

1See note 1 for table 1 of this document. 

Dated: August 31, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21302 Filed 9–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Application for Allowance in 

Duties 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 60-Day notice and request for 

comments; extension of an existing 

collection of information: 1651–0007. 

SUMMARY: As part of its continuing effort 

to reduce paperwork and respondent 

burden, CBP invites the general public 

and other Federal agencies to comment 

on an information collection 

requirement concerning the Application 

for Allowance in Duties. This request 

for comment is being made pursuant to 

the Paperwork Reduction Act of 1995 

(Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). 

DATES: Written comments should be 

received on or before November 3, 2009, 

to be assured of consideration. 

ADDRESSES: Direct all written comments 

to U.S. Customs and Border Protection, 

Attn: Tracey Denning, Office of 

Regulations and Rulings, 799 9th Street, 

NW., 7th Floor, Washington, DC 20229– 

1177. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Office of Regulations and Rulings, 799 

9th Street, NW., 7th Floor, Washington, 

DC 20229–1177, at 202–325–0265. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) the 

annual cost burden to respondents or 

recordkeepers from the collection of 

information (total capital/startup costs 

and operations and maintenance costs). 

The comments that are submitted will 

be summarized and included in the CBP 

request for Office of Management and 

Budget (OMB) approval. All comments 

will become a matter of public record. 

In this document CBP is soliciting 

comments concerning the following 

information collection: 

Title: Application for Allowance in 

Duties. 

OMB Number: 1651–0007. 

Form Number: CBP Form 4315. 

Abstract: Form 4315 is required by 

CBP in instances of claims of damaged 

or defective imported merchandise on 

which an allowance in duty is made in 

the liquidation of an entry. The 

information is used to substantiate an 

importer’s claim for such duty 

allowances. 

Current Actions: There are no changes 

to the information collection. This 

submission is being made to extend the 

expiration date. 

Type of Review: Extension (without 

change). 

Affected Public: Businesses. 

Estimated Number of Respondents: 

12,000. 

Estimated Number of Annual 

Responses per Respondent: 1. 

Estimated Time per Respondent: 8 

minutes. 

Estimated Total Annual Burden 

Hours: 1,600. 

Dated: September 1, 2009. 

Tracey Denning, 

Agency Clearance Officer, Customs and 

Border Protection. 

[FR Doc. E9–21366 Filed 9–3–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5285–N–28] 

Notice of Proposed Information 

Collection: Comment Request; 

Request for Approval of Advance of 

Escrow Funds 

AGENCY: Office of the Assistant 

Secretary for Housing, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

will be submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 


srobinson on DSKHWCL6B1PROD with NOTICES