Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is publishing a quarterly update of all guidance documents issued and withdrawn since we compiled the last quarterly list of guidance documents that published on March 14, 2000. FDA committed to publishing quarterly updates in our February 1997 "Good Guidance Practices" (GGP's) document, which set forth the agency's policies and procedures for developing, issuing, and using guidance documents. This list is intended to inform the public of the existence and availability of guidance documents issued since the annual comprehensive list was compiled.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. 98N-0046] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a quarterly update of all guidance documents issued and withdrawn since we compiled the last quarterly list of guidance documents that published on March 14, 2000. FDA committed to publishing quarterly updates in our February 1997 “Good Guidance Practices” (GGP's) document, which set forth the agency's policies and procedures for developing, issuing, and using guidance documents. This list is intended to inform the public of the existence and availability of guidance documents issued since the annual comprehensive list was compiled. DATES: General comments on this list and on agency guidance documents are welcome at any time. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For information on where to obtain single copies of guidance documents listed here, see the specific center's list of guidance documents. FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 27, 1997 ( 62 FR 8961 ), FDA published a notice announcing its “Good Guidance Practices” (GG…
Other Federal Register documents from the same docket.
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
Update of Guidance Documents at the Food and Drug Administration
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
Quarterly List of Guidance Documents at the Food and Drug Administration
Citation: 65 FR 33553