Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

HHS RELEASE OF CLAIMED CONFIDENTIAL INFORMATION WILL ONLY OCCUR FIVE DAYS after the submitter of the information is notified of its intent to release documents and given five working days to object to the release, according to an HHS rule revising its Freedom of Information (FoI) regulations. Under the rule, published in the Nov. 13 Federal Register, HHS agencies "will make reasonable efforts to notify the submitter" of confidential information "when we receive a request for such records and when we determine that we may be required to disclose them." The rule states that predisclosure notification procedures apply to information which the agency believes is confidential as well as information designated by the submitter as confidential. Notice to the submitter of the agency's plan to release information will include a copy of the request and will inform the submitter about the procedures for objecting. HHS noted that in cases where it must notify a large number of submitters "we may do this by posting or publishing a notice in a place where the submitters are reasonably likely to become aware of it." The provisions on predisclosure notification and fee collection for FoI requests were published as an interim final rule, which the agency will accept comments on until Dec. 14. The remaining sections of the regulation, dealing with basic policy, obtaining records, and release and denial of records, are effective Nov. 13. The rule's major deviations from the proposed regulation, published in April 1986 ("The Pink Sheet" April 21, "In Brief"), are in the fee collection and predisclosure notification provisions. Those changes were made, in part, to comply with amendments to the FoI Act on fee collection ("The Pink Sheet" Nov. 10, 1986, T&G-9) and on predisclosure notification ("The Pink Sheet" Aug. 11, 1986, "In Brief"). HHS' procedures for notification of document release provide the submitter with five days to object to the release of information. The agency "will give consideration to all bases that have been timely stated by the submitter," the rule states. If the agency decides to disclose the records after reviewing the objection, it will notify the submitter of its intent to release the records in five working days unless ordered "by a United States District Court not to release them." The rule notes that the agency will not follow all predisclosure notification procedures when: (1) "We decide not to disclose the records"; (2) "The information has previously been published or made generally available"; (3) "Disclosure is required by a statute other than the FoI Act"; (4) "Disclosure is required by a regulation . . . that specifies narrow categories of records that are to be disclosed under FoI"; and (5) "The designation appears to be obviously frivolous."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts