Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13339 

1Before passage of the Food and Drug 

Administration Amendments Act of 2007 (FDAAA), 

FDA could require postmarketing studies and 

clinical trials under the following circumstances: 

To verify adn describe clinical benefit for a human 

drug approved in accordance with the accelerated 

approval provisions in section 506(b)(2)(A) of the 

FD&C Act (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 not adequately labeled 

for children under section 505B of the FD&C Act 

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

L. 108–155)). 

where American Indian and Alaska 

Native (AI/AN) programs are located. 

We are convening the OHS Tribal 

Consultations in conjunction with other 

Tribal Leader events in order to 

minimize the financial and travel 

burden for participants. The sessions in 

Phoenix, Arizona, and Billings, 

Montana, are being held in conjunction 

with the HHS 2012 Regional Tribal 

Consultation Sessions. We will schedule 

additional consultations around the 

country for later in the year. 

The agenda for the scheduled OHS 

Tribal Consultations will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of AI/AN children 

and families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. In addition, OHS 

will share actions taken and in progress 

to address the issues and concerns 

raised in 2011 OHS Tribal 

Consultations. 

Tribal leaders and designated 

representatives interested in submitting 

written testimony or proposing specific 

agenda topics for these Consultation 

Sessions should contact Camille Loya at 

Camille.Loya@acf.hhs.gov. Proposals 

must be submitted at least three days in 

advance of the session and should 

include a brief description of the topic 

area, along with the name and contact 

information of the suggested presenter. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 

U.S.C.9835, Section 640(l)(4)(A)]. 

Designees must have a letter from the 

Tribal Government authorizing them to 

represent the tribe. The letter should be 

submitted at least three days in advance 

of the Consultation Session to Camille 

Loya at (202) 205–9721 (fax). Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of each Consultation 

Session will be prepared and made 

available within 90 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Camille Loya at 

Camille.Loya@acf.hhs.gov either prior to 

the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Sessions will be 

summarized in each report without 

attribution, along with topics of concern 

and recommendations. Hotel and 

logistical information for all 

Consultation Sessions has been sent to 

tribal leaders via email and posted on 

the Head Start Resource Center Web site 

at http:// 

www.headstartresourcecenter.org. 

Dated: February 28, 2012. 

Yvette Sanchez Fuentes, 

Director, Office of Head Start. 

[FR Doc. 2012–5438 Filed 3–5–12; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0169] 

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 notice 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: Meg 

Pease-Fye, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4156, Silver Spring, 

MD 20993–0002, 301–796–0700; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Modernization Act 

Section 130(a) of the Modernization 

Act (Pub. L. 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C 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 

FD&C Act (21 U.S.C. 356b)). Section 

506B of the FD&C 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 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 FD&C Act authorizing FDA 

to require certain studies and clinical 

trials for human drug and biological 

products approved under section 505 of 

the FD&C 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)(4) of the FD&C Act (21 U.S.C. 

355(o)(1), 352(z), and 333(f)(4))). 

Although regulations implementing 

the Modernization Act postmarketing 

authorities use the term ‘‘postmarketing 

commitment’’ to refer to both required 


pmangrum on DSK3VPTVN1PROD with NOTICES
13340 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

2Although the data included in this report do not 

include a summary of reports that applicants have 

failed to file by their due date, the Agency notes 

that it may take appropriate regulatory action in the 

event reports are not filed on a timely basis. 

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 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 either 

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)(3)(E) of the 

FD&C 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 the study/clinical 

trial, and (3) 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, 2011. If a requirement or 

commitment did not have a schedule, or 

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.2

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 

FD&C 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., in January, April, July, 

and October). 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13341 

3There are existing PMCs established before 

FDAAA that might meet current FDAAA standards 

for required safety studies/clinical trials under 

section 505(o)(3)(B) of the FD&C Act. Under section 

505(o)(3)(c) of the FD&C Act, the Agency may 

convert pre-existing PMCs into PMRs if it becomes 

aware of new safety information. 

Many applicants have more than one 

approved product and for many 

products there is more than one PMR or 

PMC. Specifically, there were 175 

unique applicants with 198 NDAs/ 

ANDAs that had open PMRs/PMCs. 

There were 72 unique applicants with 

99 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 2011 (FY11), 

21 percent (43/208) of NDA/ANDA and 

41 percent (41/99) of BLA annual status 

reports were not submitted within 60 

days of the anniversary date of U.S. 

approval of the original application. Of 

the annual status reports due but not 

submitted on time, 100 percent of the 

NDA/ANDA and 56 percent (23/41) of 

the BLA reports were submitted before 

the close of FY11 (September 30, 2011). 

Most PMRs are progressing on 

schedule (87 percent for NDAs/ANDAs; 

88 percent for BLAs). Most PMCs are 

also progressing on schedule (80 percent 

for NDAs/ANDAs; 75 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.3

III. About This Report 

This report provides six separate 

summary tables. The tables in this 

document 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, 2011. 

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 (87 percent for NDAs/ 

ANDAs and 88 percent for BLAs) and 

most PMCs (80 percent for NDAs/ 

ANDAs and 75 percent for BLAs) are on 

schedule. Overall, of the PMRs that are 

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

92 percent were created within the past 

3 years. Table 2 of this document shows 

that 49 percent of pending PMRs for 

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 FD&C 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 for drug and biological products 

(49 percent) comprises those studies/ 

clinical trials required by FDA under 

FDAAA, which became effective on 

March 25, 2008. 

Table 3 of this document provides 

additional detail on the status of offschedule PMRs. The majority of offschedule PMRs (which account for 13 

percent of the total for NDAs/ANDAs 

and 12 percent for BLAs) are delayed 

according to the original schedule 

milestones (98 percent (83/85) for 

NDAs/ANDAs; 95 percent (20/21) for 

BLAs). In certain situations, 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/clinical trial status reflects the 

status in relation to the original study/ 

clinical trial schedule regardless of 

whether FDA has acknowledged that 

additional time may be required to 

complete the study/clinical trial. 

Tables 4 and 5 of this document 

provide additional detail on the status 

of PMCs. Table 4 of this document 

provides additional detail on the status 

of on-schedule PMCs. Pending PMCs 

comprise 48 percent (141/295) of the onschedule NDA/ANDA PMCs and 39 

percent (81/209) 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 20 

percent for NDAs/ANDAs and 25 

percent for BLAs) are delayed according 

to the original schedule milestones (93 

percent (69/74) for NDAs/ANDAs; 97 

percent (69/71) for BLAs). As noted 

previously in this document, this report 

reflects the original due dates for study/ 

clinical trial results and does not reflect 

discussions between the Agency and the 

sponsor regarding studies/clinical trials 

that may require more time for 

completion. 

Table 6 of this document provides 

details about PMRs and PMCs that were 

concluded in the previous year. The 

majority of concluded PMRs and PMCs 

were fulfilled (70 percent of NDA/ 

ANDA PMRs and 84 percent of BLA 

PMRs; 85 percent of NDA/ANDA PMCs 

and 80 percent of BLA PMCs). 

TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS

[Numbers as of September 30, 2011] 

NDA/ANDA 

(percent of 

total PMR or 

percent of total 

PMC) 

BLA (percent 

of total PMR 

or percent of 

total PMC) 1

Number of open PMRs ............................................................................................................................................ 675 176 

On-schedule open PMRs (see table 2 of this document) ................................................................................ 590 (87% ) 155 (88% ) 

Off-schedule open PMRs (see table 3 of this document) ................................................................................ 85 (13% ) 21 (12% ) 

Number of open PMCs ............................................................................................................................................ 369 280 

On-schedule open PMCs (see table 4 of this document) ................................................................................ 295 (80% ) 209 (75% ) 


pmangrum on DSK3VPTVN1PROD with NOTICES
13342 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS—Continued 

[Numbers as of September 30, 2011] 

NDA/ANDA 

(percent of 

total PMR or 

percent of total 

PMC) 

BLA (percent 

of total PMR 

or percent of 

total PMC) 1

Off-schedule open PMCs (see table 5 of this document) ................................................................................ 74 (20% ) 71 (25% ) 

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, 2011] 

On-Schedule open PMRs 

NDA/ANDA 

(percent of 

Total PMR) 

BLA (percent 

of total PMR) 1

Pending (by type): 

Accelerated approval ........................................................................................................................................ 8 1 

PREA2 .............................................................................................................................................................. 238 34 

Animal efficacy 3 ............................................................................................................................................... 1 0 

FDAAA safety (since March 25, 2008) ............................................................................................................ 199 72 

Total ........................................................................................................................................................... 446 (66% ) 107 (61% ) 

Ongoing: 

Accelerated approval ........................................................................................................................................ 13 9 

PREA2 .............................................................................................................................................................. 35 5 

Animal efficacy 3 ............................................................................................................................................... 0 0 

FDAAA safety (since March 25, 2008) ............................................................................................................ 41 23 

Total ........................................................................................................................................................... 89 (13% ) 37 (21% ) 

Submitted: 

Accelerated approval ........................................................................................................................................ 3 2 

PREA2 .............................................................................................................................................................. 24 4 

Animal efficacy 3 ............................................................................................................................................... 0 0 

FDAAA safety (since March 25, 2008) ............................................................................................................ 28 5 

Total ........................................................................................................................................................... 55 (8% ) 11 (6% ) 

Combined total ................................................................................................................................... 590 (87% ) 155 (88% ) 

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, 2011] 

Off-Schedule open PMRs 

NDA/ANDA 

(percent of 

total PMR) 

BLA (percent 

of total PMR) 1

Delayed: 

Accelerated approval ........................................................................................................................................ 5 2 

PREA ................................................................................................................................................................ 64 12 

Animal efficacy ................................................................................................................................................. 1 0 

FDAAA safety (since March 25, 2008) ............................................................................................................ 13 6 

Total ........................................................................................................................................................... 83 (12%) 20 (11%) 

Terminated ............................................................................................................................................................... 2 (0.3%) 1 (0.6%) 

Combined total .......................................................................................................................................... 85 (13%) 21 (12%) 

1See note 1 for table 1 of this document. 


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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13343 

TABLE 4—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS

[Numbers as of September 30, 2011] 

On-Schedule open PMCs 

NDA/ANDA 

(percent of 

total PMC) 

BLA (percent 

of total PMC) 1

Pending .................................................................................................................................................................... 141 (38%) 81 (29%) 

Ongoing ................................................................................................................................................................... 77 (21%) 72 (26%) 

Submitted ................................................................................................................................................................. 77 (21%) 56 (20%) 

Combined total ................................................................................................................................................. 295 (80%) 209 (75%) 

1See note 1 for table 1 of this document. 

TABLE 5—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS

[Numbers as of September 30, 2011] 

Off-Schedule open PMCs 

NDA/ANDA 

(percent of 

total PMC) 

BLA (percent 

of total PMC) 1

Delayed .................................................................................................................................................................... 69 (19%) 69 (25%) 

Terminated ............................................................................................................................................................... 5 (1%) 2 (0.7%) 

Combined total ................................................................................................................................................. 74 (20%) 71 (25%) 

1See note 1 for table 1 of this document. 

TABLE 6—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS

[October 1, 2010 to October 1, 2011] 

NDA/ANDA 

(percent of 

total) 

BLA (percent 

of total) 1

Concluded PMRs: 

Requirement met (fulfilled) ............................................................................................................................... 55 (70%) 16 (84%) 

Requirement not met (released and new revised requirement issued) ........................................................... 21 (27%) 0 (0%) 

Requirement no longer feasible or product withdrawn (released) ................................................................... 3 (4%) 3 (16%) 

Total ........................................................................................................................................................... 79 19 

Concluded PMCs: 

Commitment met (fulfilled) ............................................................................................................................... 109 (85%) 44 (80%) 

Commitment not met (released and new revised requirement/commitment issued) ...................................... 12 (9%) 2 (4%)

Commitment no longer feasible or product withdrawn (released) ................................................................... 7 (5%) 9 (16%) 

Total ........................................................................................................................................................... 128 55 

1See note 1 for table 1 of this document. 

Dated: February 28, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5302 Filed 3–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0788] 

Pilot Program for Early Feasibility 

Study Investigational Device 

Exemption Applications; Termination 

of Acceptance of Nominations and 

Extending the Duration of the Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

termination of the acceptance of 

nominations for the Early Feasibility 

Study Investigational Device Exemption 

(IDE) Applications pilot program. This 

program allowed the submission of 

nominations from sponsors of 

innovative device technologies to 

participate in a pilot program for early 

feasibility study IDE applications. FDA 

is also announcing that the duration of 

the pilot program is extended to May 8, 

2013, for sponsors that have already 

been accepted for the program. 

DATES: This notice is effective March 6, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Brown, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1676, Silver Spring, 

MD 20993–0002, 301–796–5640. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 10, 2011 

(76 FR 70150), FDA announced the 

availability of a draft guidance entitled 

‘‘Investigational Device Exemptions 

(IDE) for Early Feasibility Medical 

Device Clinical Studies, Including 

Certain First in Human (FIH) Studies.’’ 

This guidance document is intended to 

facilitate early feasibility studies of 

medical devices, using appropriate risk 

mitigation strategies, under the IDE 

requirements. Simultaneous with the 

publication of the draft guidance, FDA 

also announced an Early Feasibility 

Study IDE Pilot Program (76 FR 70152, 

November 10, 2011) intended to collect 


pmangrum on DSK3VPTVN1PROD with NOTICES