Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Receipt Date; Availability, 31079-31080 [E7-10780]

Download as PDF Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Notices immediately in accordance with § 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate in light of the need to respond expeditiously to the recent cases of botulism linked to refrigerated carrot juice. This guidance represents the agency’s current thinking on important practices for ensuring the safety of refrigerated carrot juice and other low-acid refrigerated juices subject to the juice HACCP regulation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT). II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance at any time. 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. The guidance and 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 with access to the Internet may obtain the guidance document at https://www.cfsan.fda.gov/ guidance.html. Dated: May 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–10792 Filed 6–4–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jlentini on PROD1PC65 with NOTICES [Docket No. 2007D–0213] Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Receipt Date; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Aug<31>2005 17:28 Jun 04, 2007 Jkt 211001 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Receipt Date.’’ This draft guidance provides information on what FDA will consider to be the receipt date for certain submissions provided in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The receipt date of these submissions has a number of important regulatory implications. Under the draft guidance, FDA will not consider a submission to be received until it has passed a technical validation check to ensure that the submission can be opened, processed, and archived. 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 written or electronic comments on the draft guidance by August 6, 2007. ADDRESSES: Submit written requests for single copies of the draft 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, or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, 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 requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. 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: Gary Gensinger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1112, Silver Spring, MD 20993–0002, 301–796–0589; or Michael Fauntleroy, Center for Biologics Evaluation and Research (HFM–25), 11400 Rockville Pike,Rockville, MD 20852, 301– 827–5132. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 31079 SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Receipt Date.’’ This draft guidance provides information on what FDA will consider to be the receipt date for submissions provided in electronic format to CDER and CBER. When FDA receives a submission, the receipt date is used to determine important regulatory milestones (e.g., 30-day safety review cycle for an investigational new drug application, review performance goal date for a new drug application or biologics license application). Occasionally, however, submissions in electronic format have technical deficiencies that prevent FDA from being able to open, process, and archive them. When this occurs, FDA’s review cannot begin until these technical deficiencies are corrected. To encourage sponsors to ensure that electronic submissions are free of technical deficiencies that can delay FDA review of the submission, FDA is changing its policy on the receipt date for submissions provided in an electronic format. The guidance provides that FDA will not consider a submission to be received until it has passed a technical validation check to ensure that the submission can be opened, processed, and archived. 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 determining the receipt date for submissions 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. E:\FR\FM\05JNN1.SGM 05JNN1 31080 Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Notices III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm, https://www.fda.gov/cber/ guidelines.htm, orhttps://www.fda.gov/ ohrms/dockets/default.htm. Dated: May 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–10780 Filed 6–4–07; 8:45 am] BILLING CODE 4160–01–S publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Scholarships for Disadvantaged Students Program— (OMB No. 0915–0149)—Reinstatement DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration The Scholarships for Disadvantaged Students (SDS) Program has as its purpose the provision of funds to eligible schools to provide scholarships to full-time, financially needy students from disadvantaged backgrounds enrolled in health professions and nursing programs. Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) Number of respondents Form To qualify for participation in the SDS program, a school must be carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including students who are members of racial and ethnic minority groups (section 737(d)(1)(B) of the Public Health Service Act). A school must meet the eligibility criteria to demonstrate that the program has achieved success based on the number and/or percentage of disadvantaged students who graduate from the school. In awarding SDS funds to eligible schools, funding priorities must be given to schools based on the proportion of graduating students going into primary care, the proportion of underrepresented minority students, and the proportion of graduates working in medically underserved communities (section 737(c) of the PHS Act). The estimated response burden is as follows: Responses per respondent Hours per response Total hour burden Application ....................................................................................................... Report .............................................................................................................. 500 500 1 1 20 1 10,000 500 Total .......................................................................................................... 500 ........................ ........................ 10,500 DEPARTMENT OF HOMELAND SECURITY system of records notice for the Automated Biometric Identification System in order (1) to add a category of records that comprises unique personal identifiers that links individuals with their encounters, biometrics, records, and other data elements and (2) to add a new routine use consistent with Office of Management and Budget Memorandum M–07–16, Attachment 2 that permits DHS to be in the best position to respond in a timely and effective manner in the event of a data breach. This republished system of records notice will replace the previously published system of records notice for the Automated Biometric Identification System, Federal Register on July 27, 2006 (71 FR 42651). Office of the Secretary DATES: Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: May 24, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7–10749 Filed 6–4–07; 8:45 am] BILLING CODE 4165–15–P Written comments must be submitted on or before July 5, 2007. [Docket No. DHS–2007–0027] Privacy Office, Office of the Secretary, Department of Homeland Security. ACTION: Notice of updated Privacy Act system of records notice. jlentini on PROD1PC65 with NOTICES AGENCY: SUMMARY: The Department of Homeland Security is republishing the Privacy Act VerDate Aug<31>2005 17:28 Jun 04, 2007 You may submit comments, identified by DOCKET NUMBER DHS– 2007–0027 by one of the following methods: • Federal e-Rulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Fax: 1–866–466–5370. • Mail: Hugo Teufel III, Chief Privacy Officer, Privacy Office, Department of ADDRESSES: Privacy Act; IDENT System of Records Jkt 211001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Homeland Security, Washington, DC 20528. FOR FURTHER INFORMATION CONTACT: Claire Miller, US–VISIT Acting Privacy Officer, Department of Homeland Security, Washington, DC 20528. For privacy issues please contact: Hugo Teufel III, Chief Privacy Officer, Privacy Office, U.S. Department of Homeland Security, Washington, DC 20528. SUPPLEMENTARY INFORMATION: In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) is publishing a revision to an existing Privacy Act system of records known as Automated Biometric Identification System (IDENT). The notice for these systems of records was last published in the Federal Register on July 27, 2006 (71 FR 42651). DHS is republishing IDENT in order (1) to add a category of records that comprises unique personal identifiers that links individuals with their encounters, biometrics, records, and other data elements and (2) to add a new routine use consistent with Office of Management and Budget Memorandum M–07–16, Attachment 2 that permits DHS to be in the best position to respond in a timely and effective E:\FR\FM\05JNN1.SGM 05JNN1

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[Federal Register Volume 72, Number 107 (Tuesday, June 5, 2007)]
[Notices]
[Pages 31079-31080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10780]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0213]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Receipt Date; 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--Receipt Date.'' This draft 
guidance provides information on what FDA will consider to be the 
receipt date for certain submissions provided in electronic format to 
the Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER). The receipt date of these 
submissions has a number of important regulatory implications. Under 
the draft guidance, FDA will not consider a submission to be received 
until it has passed a technical validation check to ensure that the 
submission can be opened, processed, and archived.

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 written or electronic comments on the draft guidance 
by August 6, 2007.

ADDRESSES:  Submit written requests for single copies of the draft 
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, or the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, 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 requests. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. 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:
    Gary Gensinger, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1112, 
Silver Spring, MD 20993-0002, 301-796-0589; or
    Michael Fauntleroy, Center for Biologics Evaluation and Research 
(HFM-25), 11400 Rockville Pike,Rockville, MD 20852, 301-827-5132.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Receipt Date.'' This draft guidance provides information on what FDA 
will consider to be the receipt date for submissions provided in 
electronic format to CDER and CBER. When FDA receives a submission, the 
receipt date is used to determine important regulatory milestones 
(e.g., 30-day safety review cycle for an investigational new drug 
application, review performance goal date for a new drug application or 
biologics license application). Occasionally, however, submissions in 
electronic format have technical deficiencies that prevent FDA from 
being able to open, process, and archive them. When this occurs, FDA's 
review cannot begin until these technical deficiencies are corrected. 
To encourage sponsors to ensure that electronic submissions are free of 
technical deficiencies that can delay FDA review of the submission, FDA 
is changing its policy on the receipt date for submissions provided in 
an electronic format. The guidance provides that FDA will not consider 
a submission to be received until it has passed a technical validation 
check to ensure that the submission can be opened, processed, and 
archived.
    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 determining 
the receipt date for submissions 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.

[[Page 31080]]

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/
cber/guidelines.htm, orhttps://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10780 Filed 6-4-07; 8:45 am]
BILLING CODE 4160-01-S

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