Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Individual Case Safety Reports; Availability, 33436-33438 [E8-13269]

Download as PDF 33436 Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ‘‘CDC Grants for Public Health Research Dissertation (Panel A–3), PAR07– 231.’’ Contact Person for More Information: Sheree Marshall Williams, Ph.D., M.Sc., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone (404) 639–4896. 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: June 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8–13185 Filed 6–11–08; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: State Plan for Foster Care, Independent Living Services and Adoption Assistance under Title IV–E of the Social Security Act. OMB No.: 0980–0141. Description: A State plan is required by sections 471 and 477(b)(2), part IV– E of the Social Security Act (the Act) for each public child welfare agency requesting Federal funding for foster care, independent living services and adoption assistance under the Act. The State plan is a comprehensive narrative description of the nature and scope of a State’s programs and provides assurances the programs will be administered in conformity with the specific requirements stipulated in title IV–E. The plan must include all applicable State statutory, regulatory, or policy references and citation for each requirement as well as supporting documentation. A State may use the pre-print format prepared by the Children’s Bureau of the Administration for Children and Families or a different format on the condition that the format used includes all of the title IV–E State plan requirements of the Act. Respondents: State and Territorial Agencies (State Agencies) administering or supervising the administration of the title IV–E program. ANNUAL BURDEN ESTIMATES mstockstill on PROD1PC66 with NOTICES Title IV–E State Plan ....................................................................... Estimated Total Annual Burden Hours: 195. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project. Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. VerDate Aug<31>2005 21:47 Jun 11, 2008 Jkt 214001 Number of responses per respondent Number of respondents Instrument 13 Dated: June 5, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–13089 Filed 6–11–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2001–D–0067] (formerly Docket No. 2001D–0185) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Postmarketing Individual Case Safety Reports.’’ This draft guidance consolidates and revises information in two existing draft guidances pertaining to electronic submission of PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Average burden hours per response 1 15 Total burden hours 195 postmarketing individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments). The submission of ICSRs and ICSR attachments in an electronic format significantly improves the agency’s efficiency in processing, archiving, and reviewing the reports. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance, including comments regarding proposed collection of information, by August 11, 2008. DATES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002, or to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your ADDRESSES: E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices requests. The guidance may also be obtained by calling CBER at 1–800–835– 4709 or 301–827–1800. Submit written comments on the draft 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 http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Roger Goetsch, Center for Drug Evaluation and Research (HFD– 410), Food and Drug Administration, 12300 Twinbrook Pkwy., suite 240, Rockville, MD 20851, 301–770–9299; or Steven 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: mstockstill on PROD1PC66 with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports’’ (the electronic ICSR draft guidance). The electronic ICSR draft guidance will apply to drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs); prescription drug products marketed for human use without an approved NDA or ANDA; nonprescription drug products marketed without an approved application; biological products, including therapeutic vaccines, marketed for human use with approved biologic license applications (BLAs) and submission tracking numbers (STNs); and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264). The electronic ICSR draft guidance will not apply to prophylactic vaccines, whole blood, or components of whole blood. A. Consolidation of Earlier Guidance This electronic ICSR draft guidance consolidates and revises information pertaining to electronic submission of postmarketing ICSRs and ICSR attachments in the following guidances: • Draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports’’ issued in May 2001 (Expedited Reports draft VerDate Aug<31>2005 21:47 Jun 11, 2008 Jkt 214001 33437 consolidating all the information pertaining to electronic submission of ICSRs and ICSR attachments into a single guidance, the electronic ICSR draft guidance also provides references to technical specifications for these submissions. Since the Expedited Reports and Periodic Reports draft guidances were issued, the agency has received ICSRs for HCT/Ps regulated under section 361 of the PHS Act. On December 22, 2006, the President signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462), which amended the Federal Food, Drug, and Cosmetic Act to add safety reporting requirements for nonprescription drug products marketed without an approved application (21 U.S.C. 379aa). The recommendations in this electronic ICSR draft guidance will apply to these products as well as to products with approved NDAs, ANDAs, BLAs and STNs, and prescription drug products marketed without an approved NDA or ANDA. This 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 providing postmarketing ICSRs and B. International Standards for Electronic ICSR attachments in electronic format. It does not create or confer any rights for Transmission or on any person and does not operate FDA has cooperated with industry to bind FDA or the public. An associations, standards development alternative approach may be used if organizations, and the regulatory such approach satisfies the authorities of certain other nations to requirements of the applicable statutes promote international harmonization of and regulations. regulatory requirements. Much of this II. Comments effort has been coordinated through the International Conference on Interested persons may submit to the Harmonisation of Technical Division of Dockets Management (see Requirements for Registration of ADDRESSES) written or electronic Pharmaceuticals for Human Use (ICH). comments regarding this document. Under the auspices of the ICH, Submit a single copy of electronic standards for electronic submission of comments or two paper copies of any safety information for human drug and mailed comments, except that biological products have been individuals may submit one paper copy. developed. This draft guidance is Comments are to be identified with the intended to provide guidance to docket number found in brackets in the industry regarding submission of heading of this document. Received postmarketing ICSRs and ICSR comments may be seen in the Division attachments to FDA in electronic form of Dockets Management between 9 a.m. using the standards established by the and 4 p.m., Monday through Friday. ICH. Please note that on January 15, 2008, C. Updated Recommendations the FDA Division of Dockets As a result of comments received on Management Web site transitioned to the Expedited Reports and Periodic the Federal Dockets Management Reports draft guidances, as well as System (FDMS). FDMS is a evolving technology, a number of Government-wide, electronic docket substantive changes have been made to management system. Electronic the agency’s recommendations for the comments or submissions will be electronic transmission of ICSRs and accepted by FDA only through FDMS at ICSR attachments. In addition to http://www.regulations/gov. guidance) (66 FR 22585, May 4, 2001), and • Draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports’’ issued in June 2003 (Periodic Reports draft guidance) (68 FR 37504, June 24, 2003). The electronic ICSR draft guidance replaces the Expedited Reports draft guidance in its entirety, and we have removed the Expedited Reports draft guidance from the Center for Drug Evaluation and Research (CDER) and CBER’s guidance pages. The electronic ICSR draft guidance also replaces the ICSR and ICSR attachment portion of the Periodic Reports draft guidance, but does not address the descriptive information portion. We have removed the Periodic Reports draft guidance from CDER and CBER’s guidance pages. For information on electronic submission of the descriptive information portion of periodic adverse drug experience reports, see the section on periodic safety update reports in the guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’’ (see Revision 2, June 2008). PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 33438 Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices III. Paperwork Reduction Act of 1995 This electronic ICSR draft guidance refers to proposed collections of information required by Public Law 109–462 and subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501– 3520). As required by the PRA, FDA is now requesting public comment (see DATES) on these proposed collections of information. The agency’s analysis and estimates of the proposed collections of information in the electronic ICSR draft guidance that are required by Public Law 109–462 have been described previously in FDA’s notice of availability for a draft guidance entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application’’ (72 FR 58316, October 15, 2007) (the October 2007 PRA analysis). For burden estimates for the proposed collections of information in the electronic ICSR draft guidance, see the October 2007 PRA analysis. This electronic ICSR draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 310.305, 314.80, 600.80, and 1271.350 have been approved under OMB control numbers 0910–0291, 0910–0230, 0910–0308, and 0910–0543 respectively. IV. Electronic Access Persons with access to the Internet may obtain the document athttp:// www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/ guidelines.htm, or http:// www.regulations.gov. Dated: June 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–13269 Filed 6–11–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on PROD1PC66 with NOTICES [Docket No. FDA–2008–D–0339] Draft Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Aug<31>2005 21:47 Jun 11, 2008 Jkt 214001 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.’’ The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This draft guidance informs industry of how FDA intends to comply with the FDAAA requirement. Specifically, the draft guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. This draft guidance also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing (AST) devices. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by August 11, 2008. Submit written comments on the proposed collection of information by August 11, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002 or the Division of Small Manufacturers Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850–4307. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance, including comments regarding proposed collection of information, to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Regarding antibacterial drug products: Edward Cox, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6414, Silver Spring, MD 20993–0002, 301–796–1300, or Regarding AST devices: Freddie Poole, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–0712. SUPPLEMENTARY INFORMATION: I. Background Antibacterial susceptibility testing is used to determine if bacteria that are isolated from a patient with an infection are likely to be killed or inhibited by a particular antibacterial drug product at the concentrations of the drug that are attainable at the site of infection using the dosing regimen(s) indicated in the drug product’s labeling. The results from antibacterial susceptibility testing generally categorize bacteria as ‘‘susceptible,’’ ‘‘intermediate,’’ or ‘‘resistant’’ to each of the antibacterial drugs that are tested. When available, culture and susceptibility testing results are one of the factors that physicians consider when selecting an antimicrobial drug product for treating a patient. The numerical values generated by susceptibility testing to determine whether a particular microorganism is susceptible to a particular antimicrobial drug—the antimicrobial susceptibility test interpretive criteria—are commonly referred to as breakpoints. These breakpoints are specified in the antimicrobial drug product’s label. The antimicrobial susceptibility test interpretive criteria can be used to interpret results from either manual or automated AST devices. On September 27, 2007, the President signed FDAAA (Public Law 110–85) into law. Section 1111 of FDAAA requires FDA to identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and to make those findings publicly available. By enacting section 1111 of FDAAA, Congress recognized the importance of maintaining updated susceptibility test interpretive criteria. FDA is announcing the availability of a draft guidance for industry entitled ‘‘Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices’’ to inform industry of how FDA intends to comply with section 1111 of FDAAA. The draft guidance explains E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33436-33438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13269]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0067] (formerly Docket No. 2001D-0185)


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Postmarketing Individual Case Safety Reports; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Individual 
Case Safety Reports.'' This draft guidance consolidates and revises 
information in two existing draft guidances pertaining to electronic 
submission of postmarketing individual case safety reports (ICSRs) and 
attachments to ICSRs (ICSR attachments). The submission of ICSRs and 
ICSR attachments in an electronic format significantly improves the 
agency's efficiency in processing, archiving, and reviewing the 
reports.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance, 
including comments regarding proposed collection of information, by 
August 11, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your

[[Page 33437]]

requests. The guidance may also be obtained by calling CBER at 1-800-
835-4709 or 301-827-1800. Submit written comments on the draft 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 http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Roger Goetsch, Center for Drug Evaluation and Research (HFD-410), 
Food and Drug Administration, 12300 Twinbrook Pkwy., suite 240, 
Rockville, MD 20851, 301-770-9299; or
    Steven 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

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Postmarketing Individual Case Safety Reports'' (the electronic ICSR 
draft guidance). The electronic ICSR draft guidance will apply to drug 
products marketed for human use with approved new drug applications 
(NDAs) and abbreviated new drug applications (ANDAs); prescription drug 
products marketed for human use without an approved NDA or ANDA; 
nonprescription drug products marketed without an approved application; 
biological products, including therapeutic vaccines, marketed for human 
use with approved biologic license applications (BLAs) and submission 
tracking numbers (STNs); and human cells, tissues, and cellular and 
tissue-based products (HCT/Ps) regulated under section 361 of the 
Public Health Service Act (the PHS Act) (42 U.S.C. 264). The electronic 
ICSR draft guidance will not apply to prophylactic vaccines, whole 
blood, or components of whole blood.

A. Consolidation of Earlier Guidance

    This electronic ICSR draft guidance consolidates and revises 
information pertaining to electronic submission of postmarketing ICSRs 
and ICSR attachments in the following guidances:
     Draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Expedited 
Safety Reports'' issued in May 2001 (Expedited Reports draft guidance) 
(66 FR 22585, May 4, 2001), and
     Draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Periodic 
Adverse Drug Experience Reports'' issued in June 2003 (Periodic Reports 
draft guidance) (68 FR 37504, June 24, 2003).
    The electronic ICSR draft guidance replaces the Expedited Reports 
draft guidance in its entirety, and we have removed the Expedited 
Reports draft guidance from the Center for Drug Evaluation and Research 
(CDER) and CBER's guidance pages. The electronic ICSR draft guidance 
also replaces the ICSR and ICSR attachment portion of the Periodic 
Reports draft guidance, but does not address the descriptive 
information portion. We have removed the Periodic Reports draft 
guidance from CDER and CBER's guidance pages. For information on 
electronic submission of the descriptive information portion of 
periodic adverse drug experience reports, see the section on periodic 
safety update reports in the guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Human Pharmaceutical 
Product Applications and Related Submissions Using the eCTD 
Specifications'' (see Revision 2, June 2008).

B. International Standards for Electronic Transmission

    FDA has cooperated with industry associations, standards 
development organizations, and the regulatory authorities of certain 
other nations to promote international harmonization of regulatory 
requirements. Much of this effort has been coordinated through the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). Under the auspices 
of the ICH, standards for electronic submission of safety information 
for human drug and biological products have been developed. This draft 
guidance is intended to provide guidance to industry regarding 
submission of postmarketing ICSRs and ICSR attachments to FDA in 
electronic form using the standards established by the ICH.

C. Updated Recommendations

    As a result of comments received on the Expedited Reports and 
Periodic Reports draft guidances, as well as evolving technology, a 
number of substantive changes have been made to the agency's 
recommendations for the electronic transmission of ICSRs and ICSR 
attachments. In addition to consolidating all the information 
pertaining to electronic submission of ICSRs and ICSR attachments into 
a single guidance, the electronic ICSR draft guidance also provides 
references to technical specifications for these submissions.
    Since the Expedited Reports and Periodic Reports draft guidances 
were issued, the agency has received ICSRs for HCT/Ps regulated under 
section 361 of the PHS Act. On December 22, 2006, the President signed 
the Dietary Supplement and Nonprescription Drug Consumer Protection Act 
(Public Law 109-462), which amended the Federal Food, Drug, and 
Cosmetic Act to add safety reporting requirements for nonprescription 
drug products marketed without an approved application (21 U.S.C. 
379aa). The recommendations in this electronic ICSR draft guidance will 
apply to these products as well as to products with approved NDAs, 
ANDAs, BLAs and STNs, and prescription drug products marketed without 
an approved NDA or ANDA.
    This 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 providing 
postmarketing ICSRs and ICSR attachments in electronic format. 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 statutes 
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations/gov.

[[Page 33438]]

III. Paperwork Reduction Act of 1995

    This electronic ICSR draft guidance refers to proposed collections 
of information required by Public Law 109-462 and subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As required by the PRA, 
FDA is now requesting public comment (see DATES) on these proposed 
collections of information. The agency's analysis and estimates of the 
proposed collections of information in the electronic ICSR draft 
guidance that are required by Public Law 109-462 have been described 
previously in FDA's notice of availability for a draft guidance 
entitled ``Postmarketing Adverse Event Reporting for Nonprescription 
Human Drug Products Marketed Without an Approved Application'' (72 FR 
58316, October 15, 2007) (the October 2007 PRA analysis). For burden 
estimates for the proposed collections of information in the electronic 
ICSR draft guidance, see the October 2007 PRA analysis.
    This electronic ICSR draft guidance also refers to previously 
approved collections of information found in FDA regulations. The 
collections of information in 21 CFR 310.305, 314.80, 600.80, and 
1271.350 have been approved under OMB control numbers 0910-0291, 0910-
0230, 0910-0308, and 0910-0543 respectively.

IV. Electronic Access

    Persons with access to the Internet may obtain the document 
athttp://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, or http://www.regulations.gov.

    Dated: June 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13269 Filed 6-11-08; 8:45 am]
BILLING CODE 4160-01-S