[Federal Register: April 22, 2002 (Volume 67, Number 77)]
[Notices]
[Page 19578]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap02-59]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0080]
Draft ``Guidance for Industry: Streamlining the Donor Interview
Process: Recommendations for Self-Administered Questionnaires;''
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Guidance for
Industry: Streamlining the Donor Interview Process: Recommendations for
Self-Administered Questionnaires'' dated April 2002. The draft
document, when finalized, is intended to provide guidance to blood and
plasma collection centers on the recommendations of FDA for
implementing self-administered donor questionnaires at the predonation
donor screening interview. The draft guidance document also describes
the information to be included in a biologics license application
supplement or annual report for the implemented changes.
DATES: Submit written or electronic comments on the draft guidance
document to ensure their adequate consideration in preparation of the
final document by June 21, 2002. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Office of Communication, Training, and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,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The document may also be
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800, or by fax by calling the FAX Information
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit written comments on the draft guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Michael D. Anderson, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance document
entitled ``Guidance for Industry: Streamlining the Donor Interview
Process: Recommendations for Self-Administered Questionnaires'' dated
April 2002. The draft guidance document, when finalized, is intended to
provide recommendations to the blood and plasma collection centers on
the changes from the current predonation donor screening interview
procedure to a self-administered format. The draft guidance document
also describes the information to be included in a biologics license
application supplement or annual report for the implemented changes.
The draft guidance document does not address the informed consent
process or specific screening questions, a specific questionnaire, or
how to submit changes to the questions on a currently approved
questionnaire.
The draft guidance document is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance
document represents the agency'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 requirements of the applicable statutes
and regulations.
II. Comments
The draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Dockets Management Branch (address
above) written or electronic comments regarding this draft guidance
document and on the collection of information. Submit written or
electronic comments to ensure adequate consideration in preparation of
the final document by June 21, 2002. Two copies of any comments are to
be submitted, except individuals may submit one copy. Comments should
be identified with the docket number found in the brackets in the
heading of this document. A copy of the document and received comments
are available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/
dockets/default.htm.
Dated: March 12, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-9687 Filed 4-19-02; 8:45 am]
BILLING CODE 4160-01-S