Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability, 8379-8381 [05-3221]

Download as PDF Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Notices The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0049] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability II. Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit written or electronic comments to ensure adequate consideration in preparation of the final guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. SUMMARY: The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency’s report on the status of the studies sponsors have agreed to or are required to conduct. FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research (HFD–20), Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852, 301–594–3937; 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: III. The Paperwork Reduction Act of 1995 I. Background 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 (section 506B of the act (21 U.S.C. 356b)) for human drug and biological products. Section 506B of the act provides FDA with additional authority to monitor the progress of a postmarketing study commitment that an applicant has been required or has agreed to conduct by requiring the applicant to submit a report annually providing information on the status of the postmarketing study commitment. This report must also include reasons, if any, for failure to complete the commitment. In the Federal Register of December 1, 1999 (64 FR 67207), FDA published a proposed rule providing a framework for the content and format of the annual progress report. The proposed rule also clarified the scope of the reporting requirement and the timing for submission of the annual progress reports. The final rule, published in the Federal Register of October 30, 2000 (65 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection(s) of information mentioned in the guidance regarding the submission of manufacturer’s information in an IND was approved under OMB control number 0910–0014. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. Dated: February 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–3106 Filed 2–17–05; 8:45 am] BILLING CODE 4160–01–S VerDate jul<14>2003 15:41 Feb 17, 2005 Jkt 205001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 8379 FR 64607), modified 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). These regulations became effective on April 30, 2001. The regulations apply only to human drug and biological products. They do not apply to animal drug or to biological products that also meet the definition of a medical device. Sections 314.81(b)(2)(vii) and 601.70 apply to postmarketing commitments made on or before enactment of the Modernization Act (November 21, 1997) as well as those made after that date. 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 that is required by FDA (e.g., accelerated approval clinical benefit studies) 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 other types of postmarketing commitments (e.g., those concerning chemistry, manufacturing, production controls, and studies 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). According to the regulations, once a postmarketing study commitment has been made, an applicant must report on the progress of the commitment on the anniversary of the product’s approval until the postmarketing study commitment is completed or terminated, and FDA determines that the postmarketing study commitment has been fulfilled or that the postmarketing study commitment is either no longer feasible or would no longer provide useful information. The annual progress report must include a description of the postmarketing study commitment, a schedule for completing the study commitment, and a characterization of the current status of the study commitment. The report must also provide an explanation of the postmarketing study commitment’s status by describing briefly the postmarketing study commitment’s progress. A postmarketing study commitment schedule is expected to E:\FR\FM\18FEN1.SGM 18FEN1 8380 Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Notices include the actual or projected dates for the following items: (1) Submission of the study protocol to FDA; (2) completion of patient accrual or initiation of an animal study; (3) completion of the study; and (4) submission of the final study report to FDA. The postmarketing study commitment status must be described in the annual report according to the following definitions: • Pending: The study has not been initiated, but does not meet the criterion for delayed; • Ongoing: The study is proceeding according to or ahead of the original schedule; • Delayed: The study is behind the original schedule; • Terminated: The study was ended before completion, but a final study report has not been submitted to FDA; or • Submitted: The study has been completed or terminated, and a final study report has been submitted to FDA. Databases containing information on postmarketing study commitments are maintained at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Information in this report covers any postmarketing study commitment that was made, in writing, at the time of approval or after approval of an application or a supplement to an application, including those required (e.g., to demonstrate clinical benefit of a product following accelerated approval) and those agreed to with the applicant. Information summarized in this report includes the following items: (1) The number of applicants with open (uncompleted) postmarketing commitments; (2) the number of open postmarketing commitments; (3) the status of open postmarketing commitments as reported in § 314.81(b)(2)(vii) or § 601.70 annual reports; (4) the status of concluded postmarketing studies as determined by FDA; and (5) the number of applications with open postmarketing commitments for which sponsors did not submit an annual report within 60 days of the anniversary date of U.S. approval. Additional information about postmarketing study commitments made by sponsors to CDER and CBER are provided on FDA’s Web site at https://www.fda.gov/cder. Like this notice, the site does not list postmarketing study commitments containing proprietary information. It is FDA policy not to post information on the Web site until it has been reviewed for accuracy. The numbers published in this notice cannot be compared with the numbers resulting from searches of the Web site. This notice incorporates totals for all postmarketing study commitments in FDA databases, including those undergoing review for accuracy. The report in this notice is updated annually while the Web site is updated quarterly (in April, July, October, and January). II. Summary of Information From Postmarketing Study Progress Reports This report summarizes the status of postmarketing commitments as of September 30, 2004. If a commitment did not have a schedule or a postmarketing progress report was not received, the commitment is categorized according to the most recent information available to the agency. Data in table 1 of this document are numerical summaries generated from FDA databases. The data are broken out according to application type (NDAs/ ANDAs or BLAs). TABLE 1.—SUMMARY OF POSTMARKETING STUDY COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2004) NDAs/ANDAs (% of Total) Applicants with Open Postmarketing Commitments BLAs1 (% of Total) 54 1,191 Number of Open Postmarketing Commitments 46 288 Status of Open Postmarketing Commitments • Pending • Ongoing • Delayed • Terminated • Submitted 812 (68%) 219 (18%) 15 (1%) 2 (<1%) 143 (12%) Concluded Studies (October 1, 2003, through September 30, 2004) • Commitment Met • Commitment Not Met • Study No Longer Needed or Feasible 157 114 (73%) 0 43 (27%) 62 45 (73%) 0 17 (27%) 18 (16%) 51 (66%) Applications with Open Postmarketing Commitments with Annual Reports Due but Not Submitted within 60 Days of the Anniversary Date of U.S. Approval 69 114 37 1 67 (24%) (40%) (13%) (<1%) (23%) 1 On October 1, 2003, FDA completed a consolidation of certain products formerly regulated by CBER into CDER. The previous association of BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year statistics for CDER BLA postmarketing study commitments will continue to be counted under BLA totals in this table. VerDate jul<14>2003 15:41 Feb 17, 2005 Jkt 205001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1 Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Notices Dated: February 10, 2005. Jeffrey Shuren, Associate Commissioner for Policy. [FR Doc. 05–3221 Filed 2–17–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0057] Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a reviewer guidance entitled ‘‘Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review.’’ The guidance is intended to provide an annotated outline of the safety component of a clinical review of a new drug or biologic product application and guidance on how to conduct and organize the safety review. The guidance is also intended to provide standardization and consistency in the format, content, and quality of safety reviews. This reviewer guidance has been developed as part of the agency’s good review practices initiative. DATES: General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug Evaluation and Research (HFD–40), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–6758. VerDate jul<14>2003 15:41 Feb 17, 2005 Jkt 205001 SUPPLEMENTARY INFORMATION: This good review practice (GRP) guidance is intended to assist reviewers conducting clinical safety reviews as part of the new drug application (NDA) and biologics license application (BLA) review process. The guidance provides standardization and consistency in the format and content of safety reviews and will help ensure that critical presentations and analyses are not inadvertently omitted. The standardized structure of this guidance will enable subsequent reviewers and other readers to readily locate specific safety information. This guidance is entirely compatible with the clinical review template, which has been developed in the Center for Drug Evaluation and Research for use by application reviewers. The guidance is structured as an annotated outline to corrolate exactly with the section headings of the review template, providing the pertinent guidance under each heading. The commentary and suggestions under each section of the guidance, together with appended examples, provide suggested analyses, methods of presentations, and discussion of special cases and potential difficulties. In 1996, FDA announced the availability of the draft version of this guidance. A number of comments were received, and the agency considered them carefully as it finalized the guidance. The changes that were made to the guidance were intended primarily to make it consistent with the template reviewers are using to evaluate marketing applications. Some minor clarifying changes also were made. This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the guidance at any time. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain the guidance at either PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 8381 https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: February 10, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–3181 Filed 2–17–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration New Methodology and Increase in Low Income Levels for Various Health Professions and Nursing Training and Assistance Programs AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice. SUMMARY: HRSA uses ‘‘low-income’’ levels to determine whether an individual is from an economically disadvantaged background in making eligibility and funding determinations for participants in various health professions and nursing grant and cooperative agreement programs authorized by Titles III, VII and VIII of the Public Health Service (PHS) Act. In the past, an individual’s economically disadvantaged background status, as a basis for participation in certain programs, was based on the income level of the individual’s parents. However, many potential program participants are well above the age of majority. Accordingly, questions have been raised by potential program participants and program officials regarding the feasibility and fairness in determining economically disadvantaged status based solely on the parent’s income. This notice updates the low-income levels published by HRSA on August 5, 2003 (68 FR 46199–46200), and changes the methodology used to determine low income for use in these programs beginning in Fiscal Year (FY) 2005. SUPPLEMENTARY INFORMATION: HRSA publishes low-income levels of families (68 FR 46199–46200, 8/5/03) for the use of various health professions training and assistance programs funded under Titles III, VII, and VIII of the PHS Act in making eligibility and funding determinations for participants in the programs. HRSA establishes these lowincome levels based on the poverty guidelines that HHS publishes annually in the Federal Register (68 FR 7336, 2/13/2004). HHS determines the poverty guidelines based on the poverty E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Notices]
[Pages 8379-8381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3221]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0049]


Report on the Performance of Drug and Biologics Firms in 
Conducting Postmarketing Commitment Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is required, under the 
Food and Drug Administration Modernization Act of 1997 (Modernization 
Act), to report annually in the Federal Register on the status of 
postmarketing study commitments made by sponsors of approved drug and 
biological products. This is the agency's report on the status of the 
studies sponsors have agreed to or are required to conduct.

FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug 
Evaluation and Research (HFD-20), Food and Drug Administration, 5515 
Security Lane, Rockville, MD 20852, 301-594-3937; 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

    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 
(section 506B of the act (21 U.S.C. 356b)) for human drug and 
biological products. Section 506B of the act provides FDA with 
additional authority to monitor the progress of a postmarketing study 
commitment that an applicant has been required or has agreed to conduct 
by requiring the applicant to submit a report annually providing 
information on the status of the postmarketing study commitment. This 
report must also include reasons, if any, for failure to complete the 
commitment.
    In the Federal Register of December 1, 1999 (64 FR 67207), FDA 
published a proposed rule providing a framework for the content and 
format of the annual progress report. The proposed rule also clarified 
the scope of the reporting requirement and the timing for submission of 
the annual progress reports. The final rule, published in the Federal 
Register of October 30, 2000 (65 FR 64607), modified annual report 
requirements for new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs) by revising Sec.  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 
Sec.  601.70 (21 CFR 601.70). These regulations became effective on 
April 30, 2001. The regulations apply only to human drug and biological 
products. They do not apply to animal drug or to biological products 
that also meet the definition of a medical device.
    Sections 314.81(b)(2)(vii) and 601.70 apply to postmarketing 
commitments made on or before enactment of the Modernization Act 
(November 21, 1997) as well as those made after that date. 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 that is required by FDA (e.g., accelerated 
approval clinical benefit studies) 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 other types of postmarketing commitments 
(e.g., those concerning chemistry, manufacturing, production controls, 
and studies conducted on an applicant's own initiative) are not 
required to be reported under Sec. Sec.  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 Sec.  314.81(b)(2)(viii).
    According to the regulations, once a postmarketing study commitment 
has been made, an applicant must report on the progress of the 
commitment on the anniversary of the product's approval until the 
postmarketing study commitment is completed or terminated, and FDA 
determines that the postmarketing study commitment has been fulfilled 
or that the postmarketing study commitment is either no longer feasible 
or would no longer provide useful information. The annual progress 
report must include a description of the postmarketing study 
commitment, a schedule for completing the study commitment, and a 
characterization of the current status of the study commitment. The 
report must also provide an explanation of the postmarketing study 
commitment's status by describing briefly the postmarketing study 
commitment's progress. A postmarketing study commitment schedule is 
expected to

[[Page 8380]]

include the actual or projected dates for the following items: (1) 
Submission of the study protocol to FDA; (2) completion of patient 
accrual or initiation of an animal study; (3) completion of the study; 
and (4) submission of the final study report to FDA. The postmarketing 
study commitment status must be described in the annual report 
according to the following definitions:
     Pending: The study has not been initiated, but does not 
meet the criterion for delayed;
     Ongoing: The study is proceeding according to or ahead of 
the original schedule;
     Delayed: The study is behind the original schedule;
     Terminated: The study was ended before completion, but a 
final study report has not been submitted to FDA; or
     Submitted: The study has been completed or terminated, and 
a final study report has been submitted to FDA.
    Databases containing information on postmarketing study commitments 
are maintained at the Center for Drug Evaluation and Research (CDER) 
and the Center for Biologics Evaluation and Research (CBER). 
Information in this report covers any postmarketing study commitment 
that was made, in writing, at the time of approval or after approval of 
an application or a supplement to an application, including those 
required (e.g., to demonstrate clinical benefit of a product following 
accelerated approval) and those agreed to with the applicant. 
Information summarized in this report includes the following items: (1) 
The number of applicants with open (uncompleted) postmarketing 
commitments; (2) the number of open postmarketing commitments; (3) the 
status of open postmarketing commitments as reported in Sec.  
314.81(b)(2)(vii) or Sec.  601.70 annual reports; (4) the status of 
concluded postmarketing studies as determined by FDA; and (5) the 
number of applications with open postmarketing commitments for which 
sponsors did not submit an annual report within 60 days of the 
anniversary date of U.S. approval.
    Additional information about postmarketing study commitments made 
by sponsors to CDER and CBER are provided on FDA's Web site at https://
www.fda.gov/cder. Like this notice, the site does not list 
postmarketing study commitments containing proprietary information. It 
is FDA policy not to post information on the Web site until it has been 
reviewed for accuracy. The numbers published in this notice cannot be 
compared with the numbers resulting from searches of the Web site. This 
notice incorporates totals for all postmarketing study commitments in 
FDA databases, including those undergoing review for accuracy. The 
report in this notice is updated annually while the Web site is updated 
quarterly (in April, July, October, and January).

II. Summary of Information From Postmarketing Study Progress Reports

    This report summarizes the status of postmarketing commitments as 
of September 30, 2004. If a commitment did not have a schedule or a 
postmarketing progress report was not received, the commitment is 
categorized according to the most recent information available to the 
agency.
    Data in table 1 of this document are numerical summaries generated 
from FDA databases. The data are broken out according to application 
type (NDAs/ANDAs or BLAs).

   TABLE 1.--Summary of Postmarketing Study Commitments (Numbers as of
                           September 30, 2004)
------------------------------------------------------------------------
                                           NDAs/ANDAs (%  BLAs\1\  (% of
                                             of Total)        Total)
------------------------------------------------------------------------
Applicants with Open Postmarketing                    54              46
 Commitments
------------------------------------------------------------------------
Number of Open Postmarketing Commitments           1,191             288
------------------------------------------------------------------------
Status of Open Postmarketing Commitments  ..............  ..............
 Pending                               812 (68%)        69 (24%)
 Ongoing                               219 (18%)       114 (40%)
 Delayed                                 15 (1%)        37 (13%)
 Terminated                              2 (<1%)         1 (<1%)
 Submitted                             143 (12%)        67 (23%)
------------------------------------------------------------------------
Concluded Studies (October 1, 2003,                  157              62
 through September 30, 2004)
 Commitment Met                        114 (73%)        45 (73%)
 Commitment Not Met                            0               0
 Study No Longer Needed or              43 (27%)        17 (27%)
 Feasible
------------------------------------------------------------------------
Applications with Open Postmarketing            18 (16%)        51 (66%)
 Commitments with Annual Reports Due but
 Not Submitted within 60 Days of the
 Anniversary Date of U.S. Approval
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
  products formerly regulated by CBER into CDER. The previous
  association of BLA reviews only with CBER is no longer valid; BLAs are
  now received by both CBER and CDER. Fiscal year statistics for CDER
  BLA postmarketing study commitments will continue to be counted under
  BLA totals in this table.



[[Page 8381]]

    Dated: February 10, 2005.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. 05-3221 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S

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