[Federal Register Volume 63, Number 126 (Wednesday, July 1, 1998)]
[Notices]
[Pages 35937-35938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0525]
Draft Guidance for Industry: ``Promoting Medical Products in a
Changing Healthcare Environment; I. Medical Product Promotion by
Healthcare Organizations or Pharmacy Benefits Management Companies
(PBMs);'' Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until July
31, 1998, the comment period for
[[Page 35938]]
a notice announcing the availability of a draft guidance for industry
entitled ``Promoting Medical Products in a Changing Healthcare
Environment; I. Medical Product Promotion by Healthcare Organizations
or Pharmacy Benefits Management Companies (PBMs)'' that appeared in the
Federal Register of January 5, 1998 (63 FR 236). FDA is taking this
action because of the complexity and importance of the issues raised by
this draft guidance and to allow interested parties additional time to
prepare and submit comments.
DATES: Written comments by July 31, 1998. General comments on agency
guidance documents are welcome at any time.
ADDRESSES: Copies of the draft guidance for industry are available on
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit
written requests for single copies of the draft guidance for industry
``Promoting Medical Products in a Changing Healthcare Environment; I.
Medical Product Promotion by Healthcare Organizations or Pharmacy
Benefits Management Companies (PBMs)'' 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
request. Submit written comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Requests and comments should be identified with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription drugs: Laurie B. Burke, Center for Drug
Evaluation and Research (HFD-40), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2828, or via Internet at
burkel@cder.fda.gov;
Regarding prescription biological products: Toni M. Stifano, Center
for Biologics Evaluation and Research (HFM-200), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via Internet at stifano@cber.fda.gov;
Regarding restricted medical devices: Byron L. Tart, Center for
Devices and Radiological Health (HFZ-302), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4639, or
via Internet at bxt@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 5, 1998
(63 FR 236), FDA published a notice announcing the availability of a
draft guidance for industry entitled ``Promoting Medical Products in a
Changing Healthcare Environment; I. Medical Product Promotion by
Healthcare Organizations or Pharmacy Benefits Management Companies
(PBMs).'' The draft guidance is intended to assist sponsors of
regulated medical products (human drugs, biologics, and medical
devices) by describing circumstances in which they may be held
responsible for promotional activities performed by a healthcare
organization/PBM subsidiary or by a nonsubsidiary healthcare
organization/PBM that violate the Federal Food, Drug, and Cosmetic Act
and regulations issued thereunder. The draft guidance also reminds
medical product sponsors of their responsibility to submit or, in the
case of some devices, maintain historical files of promotional labeling
and advertising. Following the review of all comments received between
January 5 and July 31, 1998, the agency intends to solicit public
comment on a new draft guidance document.
Interested persons may, on or before July 31, 1998, submit to the
Dockets Management Branch (address above) written comments on this
subject. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 25, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17413 Filed 6-30-98; 8:45 am]
BILLING CODE 4160-01-F
