[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)] [Notices] [Pages 49695-49696] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-25126] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0381] Guidance for Industry on Archiving Submissions in Electronic Format--NDA's; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Archiving Submissions in Electronic Format--NDA's.'' This guidance is intended to describe how to submit records and other documents in electronic format to the Center for Drug Evaluation and Research (CDER) for archival purposes. Guidance is provided on submitting case report forms and case report tabulations as part of new drug applications (NDA's). This is the first in a series of guidances for industry that will address archiving NDA submissions in electronic format. Guidance for industry on other submission types will be made available as they are completed. The submission of records in electronic format should reduce the amount of paperwork for applicants and the agency. Submissions in electronic format are voluntary. DATES: Written comments may be submitted at any time. [[Page 49696]] ADDRESSES: Submit written requests for single copies of the guidance for industry entitled ``Archiving Submissions in Electronic Format-- NDA's'' to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Kenneth Edmunds, Center for Drug Evaluation and Research (HFD-350), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3276, e-mail: [email protected]. SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a guidance for industry entitled ``Archiving Submissions in Electronic Format--NDA's.'' Traditionally, FDA has required that regulatory submissions, such as investigational new drug applications and NDA's, be submitted as paper documents. The regulations in part 314 (21 CFR part 314), for example, set forth the requirements and procedures for submitting applications to obtain approval for the marketing of new drugs to FDA. These regulations require the submission of three copies of an application for marketing approval: (1) A complete archival copy, (2) a review copy, and (3) a field copy (Sec. 314.50(k)). In the Federal Register of March 20, 1997 (62 FR 13430), FDA published the Electronic Records; Electronic Signatures regulation that provides for the voluntary submission of parts or all of an application, as defined in the relevant regulations, in electronic format without an accompanying paper copy (21 CFR part 11). The agency also established public docket number 92S-0251 so the agency can maintain a list of the specific types of records and submissions that can be accepted in electronic format (62 FR 13467, March 20, 1997). The agency unit(s) that are prepared to receive electronic submissions are to identify themselves in that docket. The regulation states that persons should consult with the intended agency receiving unit for details on how to proceed with the electronic submission. The guidance is intended to reduce the need on the part of sponsors to consult CDER for details on archiving electronic submissions. The guidance specifically addresses the NDA and includes subsections on how to submit case report forms and case report tabulations in electronic format to CDER for the archive. Conforming to the guidance in this document will help ensure that submissions provided to CDER in electronic format can be accessed, handled, reviewed, and maintained efficiently. The guidance is the first in a series that will be issued on archiving electronic submissions to CDER. As a result, it is not all inclusive. CDER anticipates that, as this effort proceeds, sponsors, investigators, and CDER staff may develop alternative and more effective procedures for submitting electronic applications for the archive. For this reason, the guidance will be updated periodically. The guidance represents the agency's current thinking on electronic submissions for the archive for NDA's. 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 statute, regulations, or both. Interested persons may, at any time, submit written comments on the guidance to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments and requests are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. An electronic version of the guidance also is available on the Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Dated: September 17, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-25126 Filed 9-17-97; 4:58 pm] BILLING CODE 4160-01-F