Draft Guidance for Industry: Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Availability, 42022-42023 [2014-16931]

Download as PDF 42022 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–16922 Filed 7–17–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0903] Draft Guidance for Industry: Providing Submissions in Electronic Format— Postmarketing Safety Reports for Vaccines; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Providing Submissions in Electronic Format— Postmarketing Safety Reports for Vaccines’’ dated July 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). FDA recently published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help applicants required to submit postmarketing safety reports comply with the final rule. The draft guidance, when finalized, also will supersede the document entitled ‘‘Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS–1)’’ dated September 1998. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2014. sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 23:20 Jul 17, 2014 Jkt 232001 Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402–7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https://www. regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Providing Submissions in Electronic Format—Postmarketing Safety Reports for Vaccines’’ dated July 2014. The draft guidance provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products, including ICSRs and ICSR attachments, into VAERS. The guidance is applicable to vaccine products marketed for human use with approved BLAs for which CBER has regulatory responsibility. This guidance does not apply to any other biologic product. In the Federal Register of June 10, 2014 (79 FR 33072), FDA published a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help applicants subject to postmarketing safety reporting requirements comply with the final rule. Along with other information, the draft guidance provides updated information about the following: (1) Options for submitting ICSRs and ICSR attachments, as well as other postmarketing safety reports to FDA in electronic format, (2) the notification sent to submitters when PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 FDA has received the electronic postmarketing safety report, and (3) procedures for requesting temporary waivers from the electronic submission requirement. The draft guidance, when finalized, also will supersede the document entitled ‘‘Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS–1)’’ dated September 1998. 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 FDA’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. II. Paperwork Reduction Act of 1995 The information collection resulting from this draft guidance is covered by the information collection provisions of the June 10, 2014, final rule entitled ‘‘Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.’’ The information collection provisions of the final rule have been submitted to the Office of Management and Budget (OMB) for review, as required under section 3507(d) of the Paperwork Reduction Act. Prior to the effective date of the final rule, FDA will publish a notice in the Federal Register announcing OMB’s decision to approve, modify, or disapprove the information collection provisions in the final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either electronic comments regarding this document to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments 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, and will be posted to the docket at https:// www.regulations.gov. E:\FR\FM\18JYN1.SGM 18JYN1 42023 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https://www. regulations.gov. Dated: July 14, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–16931 Filed 7–17–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; A Generic Submission for Formative Research, Pre-Testing, Stakeholder Measures and Advocate Forms at NCI Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the and materials while they are under development. Additionally, administrative forms are a necessary part of collecting demographic information and areas of interest for advocates. Pre-testing, or formative evaluation, helps ensure that the products and services developed by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. Since OAR is responsible for matching advocates to NCI programs and initiatives across the cancer continuum, it is necessary to measure the satisfaction of both internal and external stakeholders with this collaboration. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many initiatives and products that OAR and NCI produce. The OAR will use a variety of qualitative (focus groups, interviews) and quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective strategies, concepts, activities; (2) use a feedback loop to help refine, revise, and enhance OAR’s efforts—ensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. The anticipated individual respondents will consist of: Adult cancer research advocates, members of the public, health care professionals, and organizational representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,025. agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kelley Landy, Acting Director of the Office of Advocacy Relations (OAR), NCI, NIH, 31 Center Drive, Bldg. 31, Room 10A28, MSC 2580, Bethesda, MD 20892, call nontoll-free number 301–594–3194, or email your request, including your address, to kelley.landy@mail.nih.gov. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: A Generic Submission for Formative Research, Pretesting, Stakeholder Measures and Advocate Forms at NCI, 0925–0641, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Office of Advocacy Relations (OAR) disseminates cancerrelated information to a variety of stakeholders, seeks input and feedback, and facilitates collaboration to advance NCI’s authorized programs. It is beneficial for NCI, through the OAR, to pretest strategies, concepts, activities ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Individuals ..................... sroberts on DSK5SPTVN1PROD with NOTICES Respondent type Self-Administered Questionnaires ....................... Individual In-Depth Interviews .............................. Focus Group Interviews ....................................... Dated: July 14, 2014. Karla Bailey, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2014–16908 Filed 7–17–14; 8:45 am] BILLING CODE 4140–01–P 800 75 100 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Mar<15>2010 23:20 Jul 17, 2014 Jkt 232001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Frequency of response 1 1 1 Average time per response (minutes/hour) Annual burden hours 1 1 90/60 800 75 150 amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42022-42023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16931]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0903]

Draft Guidance for Industry: Providing Submissions in Electronic
Format--Postmarketing Safety Reports for Vaccines; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Providing Submissions in Electronic Format--Postmarketing Safety
Reports for Vaccines'' dated July 2014. The draft guidance document
provides information and recommendations pertaining to the electronic
submission of postmarketing safety reports involving vaccine products
marketed for human use with approved biologics license applications
(BLAs), including individual case safety reports (ICSRs) and
attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event
Reporting System (VAERS). FDA recently published in the Federal
Register a final rule requiring that certain postmarketing safety
reports for human drug and biological products, including vaccines, be
submitted to FDA in an electronic format that the Agency can process,
review, and archive. The draft guidance, when finalized, is intended to
help applicants required to submit postmarketing safety reports comply
with the final rule. The draft guidance, when finalized, also will
supersede the document entitled ``Guidance for Industry: How to
Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated
September 1998.

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 comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 16, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Providing Submissions in Electronic Format--
Postmarketing Safety Reports for Vaccines'' dated July 2014. The draft
guidance provides information and recommendations pertaining to the
electronic submission of postmarketing safety reports involving vaccine
products, including ICSRs and ICSR attachments, into VAERS. The
guidance is applicable to vaccine products marketed for human use with
approved BLAs for which CBER has regulatory responsibility. This
guidance does not apply to any other biologic product.
In the Federal Register of June 10, 2014 (79 FR 33072), FDA
published a final rule requiring that certain postmarketing safety
reports for human drug and biological products, including vaccines, be
submitted to FDA in an electronic format that the Agency can process,
review, and archive. The draft guidance, when finalized, is intended to
help applicants subject to postmarketing safety reporting requirements
comply with the final rule. Along with other information, the draft
guidance provides updated information about the following: (1) Options
for submitting ICSRs and ICSR attachments, as well as other
postmarketing safety reports to FDA in electronic format, (2) the
notification sent to submitters when FDA has received the electronic
postmarketing safety report, and (3) procedures for requesting
temporary waivers from the electronic submission requirement. The draft
guidance, when finalized, also will supersede the document entitled
``Guidance for Industry: How to Complete the Vaccine Adverse Event
Reporting System Form (VAERS-1)'' dated September 1998.
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 FDA'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.

II. Paperwork Reduction Act of 1995

The information collection resulting from this draft guidance is
covered by the information collection provisions of the June 10, 2014,
final rule entitled ``Postmarketing Safety Reports for Human Drug and
Biological Products; Electronic Submission Requirements.'' The
information collection provisions of the final rule have been submitted
to the Office of Management and Budget (OMB) for review, as required
under section 3507(d) of the Paperwork Reduction Act. Prior to the
effective date of the final rule, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions in the final rule. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.

III. Comments

The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments 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, and will be posted to the docket at https://www.regulations.gov.

[[Page 42023]]

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16931 Filed 7-17-14; 8:45 am]
BILLING CODE 4164-01-P

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