Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability, 1359-1360 [E8-143]

Download as PDF Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices This final guidance document, ‘‘The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,’’ explains for PMA applicants the administrative process FDA intends to follow in its review of the PMA manufacturing section information and the inspection of the particular manufacturing facility and its manufacturing operations. This final guidance document supersedes the corresponding draft guidance issued on June 19, 2006 (71 FR 35275 through 35276). The comment period for the draft guidance document closed on September 18, 2006. During the comment period, we received several comments and recommendations. Two comments recommended that the agency inspect pilot manufacturing operations or the manufacture of a surrogate product in lieu of inspecting the complete manufacturing operation described in the PMA manufacturing section. FDA disagrees with this recommendation as the statute does not provide such an alternative. The statute requires the agency to determine whether the manufacturing operations, as described in the PMA, conform to good manufacturing practice requirements. Several comments recommended clarification of certain terms related to the process involved with scheduling inspections and factors that affect the PMA manufacturing section review process. The agency incorporated many of the suggested clarifications. pwalker on PROD1PC71 with NOTICES II. Significance of Guidance This 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 ‘‘The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.’’ 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. identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 USC 3501– 3520). The collections of information in 21 CFR part 814 have been approved under OMB Control Number 0910–0231; and the collections of information in 21 CFR part 820 have been approved under OMB Control Number 0910–0073. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. 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 brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,’’ you may either send Dated: December 20, 2007. an e-mail request to dsmica@fda.hhs.gov Jeffrey Shuren, to receive an electronic copy of the Assistant Commissioner for Policy. document or send a fax request to 240– 276–3151 to receive a hard copy. Please [FR Doc. E8–126 Filed 1–7–08; 8:45 am] BILLING CODE 4160–01–S use the document number 1566 to VerDate Aug<31>2005 17:32 Jan 07, 2008 Jkt 214001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 1359 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0228] Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program.’’ This guidance provides premarket approval application (PMA) applicants with information about the bioresearch monitoring (BIMO) review process. This includes a BIMO evaluation of clinical and nonclinical information in the PMA and certain PMA supplements as well as preapproval BIMO inspections. The procedural information outlined in this document should help applicants and FDA to better understand the BIMO review and inspection so it can proceed in a timely manner. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 240–276–3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this 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 or https://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Matthew J. Tarosky, Center for Devices E:\FR\FM\08JAN1.SGM 08JAN1 1360 Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices and Radiological Health (HFZ–300), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–0243. SUPPLEMENTARY INFORMATION: pwalker on PROD1PC71 with NOTICES I. Background On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107– 250) was signed into law. Among other things, MDUMFA authorized the collection of user fees to improve the performance and predictability of FDA’s device review program, including premarket approval applications (PMAs). One such goal included a commitment to improve the scheduling and timeliness of PMA preapproval inspections. A portion of the user fees collected under MDUFMA will be used to help to cover the costs associated with the bioresearch monitoring (BIMO) program review of a PMA and the performance of any related clinical or nonclinical inspections. This final guidance document supersedes the corresponding draft guidance entitled ‘‘The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program,’’ which was announced in the Federal Register on June 20, 2006 (71 FR 35436 through 35437). The comment period for the draft guidance closed on September 18, 2006. During this time, FDA received one set of comments from a device manufacturer concerning the draft guidance. Some of the comments suggested combining the BIMO and manufacturing preapproval inspections. FDA did not make changes in response to these comments because preapproval BIMO and manufacturing inspections can not be performed at the same time. Compared to the preapproval manufacturing inspection program, the BIMO program has different objectives, usually involves inspections of different sites, and FDA investigators with different expertise. FDA did modify the guidance to respond to comments that requested further information about criteria for selecting inspection sites and determining when followup actions are necessary. II. Significance of Guidance This 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 ‘‘The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the VerDate Aug<31>2005 17:32 Jan 07, 2008 Jkt 214001 public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number 1602 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 USC 3501– 3520). The collections of information in 21 CFR part 814 have been approved under OMB Control Number 0910–0231. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 heading of this document. Received comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–143 Filed 1–7–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Panel Meeting on the Murine Local Lymph Node Assay; Availability of Draft Background Review Documents; Request for Comments National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Meeting announcement and request for comments. AGENCY: SUMMARY: NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces an independent scientific peer review panel meeting to evaluate modifications and new applications for the Murine Local Lymph Node Assay (LLNA). The LLNA is an alternative test method that can be used to determine the allergic contact dermatitis potential of chemicals and products. The panel will review the following: • The validation status of three modified LLNA test method protocols that use non-radioactive probe chemicals. • The validation status of a LLNA limit dose procedure. • The use of the LLNA to test mixtures, aqueous solutions, and metals (applicability domain for the LLNA). • The use of the LLNA to determine potency (potential for causing allergic contact dermatitis). • Revised draft recommended performance standards for the LLNA. At this meeting, the panel will peer review the draft background review documents and revised draft LLNA performance standards for each topic and evaluate the extent that established validation and acceptance criteria have been appropriately addressed. The panel will also comment on the extent E:\FR\FM\08JAN1.SGM 08JAN1

Agencies

[Federal Register Volume 73, Number 5 (Tuesday, January 8, 2008)]
[Notices]
[Pages 1359-1360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-143]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0228]


Guidance for Industry and Food and Drug Administration Staff; The 
Review and Inspection of Premarket Approval Applications Under the 
Bioresearch Monitoring Program; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``The Review and Inspection of 
Premarket Approval Applications Under the Bioresearch Monitoring 
Program.'' This guidance provides premarket approval application (PMA) 
applicants with information about the bioresearch monitoring (BIMO) 
review process. This includes a BIMO evaluation of clinical and 
nonclinical information in the PMA and certain PMA supplements as well 
as preapproval BIMO inspections. The procedural information outlined in 
this document should help applicants and FDA to better understand the 
BIMO review and inspection so it can proceed in a timely manner.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``The Review and Inspection of Premarket Approval 
Applications Under the Bioresearch Monitoring Program'' to the Division 
of Small Manufacturers, International, and Consumer Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 240-276-3151. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this 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 or https://www.regulations.gov. 
Identify comments with the docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Matthew J. Tarosky, Center for Devices

[[Page 1360]]

and Radiological Health (HFZ-300), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-0243.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 26, 2002, the Medical Device User Fee and Modernization 
Act of 2002 (MDUFMA) (Public Law 107-250) was signed into law. Among 
other things, MDUMFA authorized the collection of user fees to improve 
the performance and predictability of FDA's device review program, 
including premarket approval applications (PMAs). One such goal 
included a commitment to improve the scheduling and timeliness of PMA 
preapproval inspections. A portion of the user fees collected under 
MDUFMA will be used to help to cover the costs associated with the 
bioresearch monitoring (BIMO) program review of a PMA and the 
performance of any related clinical or nonclinical inspections. This 
final guidance document supersedes the corresponding draft guidance 
entitled ``The Review and Inspection of Premarket Approval Applications 
Under the Bioresearch Monitoring Program,'' which was announced in the 
Federal Register on June 20, 2006 (71 FR 35436 through 35437).
    The comment period for the draft guidance closed on September 18, 
2006. During this time, FDA received one set of comments from a device 
manufacturer concerning the draft guidance. Some of the comments 
suggested combining the BIMO and manufacturing preapproval inspections. 
FDA did not make changes in response to these comments because 
preapproval BIMO and manufacturing inspections can not be performed at 
the same time. Compared to the preapproval manufacturing inspection 
program, the BIMO program has different objectives, usually involves 
inspections of different sites, and FDA investigators with different 
expertise. FDA did modify the guidance to respond to comments that 
requested further information about criteria for selecting inspection 
sites and determining when followup actions are necessary.

II. Significance of Guidance

    This 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 ``The Review and Inspection of Premarket 
Approval Applications Under the Bioresearch Monitoring Program.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``The Review and Inspection of Premarket 
Approval Applications Under the Bioresearch Monitoring Program,'' you 
may either send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 240-276-3151 
to receive a hard copy. Please use the document number 1602 to identify 
the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The 
collections of information in 21 CFR part 814 have been approved under 
OMB Control Number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, 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. Received comments received 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-143 Filed 1-7-08; 8:45 am]
BILLING CODE 4160-01-S

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