In the Omnibus Reconciliation Act of 1980, Pub. L. No.

The

96-499, 42 U.S.C. § 1320c-15 note (1981), a delay period of at least one year from the date of entry of a final court order requiring any materials to be disclosed by Professional Standards Review Organizations (PSROs) was enacted by the Congress. Congressional intent, as referenced in the conference report, was to provide time for the Congress to have the benefit of full judicial consideration of the issue of disclosure of PSRO materials. AHS finds no valid reason for distinguishing PSRO materials from other HHS agency records. In many situations, PSRO decision-making takes the place of agency decision-making. To delay the receipt of materials for one year creates a great injustice to anyone seeking to acquire the information, since the PSROS now routinely deny all such requests, secure in the knowledge that they are virtually immune from the FOIA by virtue of this prohibitory section. For this dispute, AHS has sought information concerning the PSRO program from both the Department and individual PSROS.

AHS is interested only in the fair and just administration of the PSRO program with regard to AHS, and to ensure that AHS and Raleigh Hills Hospitals receive the process that is due them. The confidentiality of patient records is properly protected by the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act, 42 U.S.C. § 4582

et seq.

We would submit that this type of ad hoc limitation on otherwise releasable documents is both unwise and unnecessary. This provision, which should not have been part of a Reconciliation Act at all, should be rescinded during this Congress.

3.

Document Indexing.

A current difficulty in the procedural operation of the

FOIA concerns the quality of the governmental responses to requests. Often, when the government agency claims that material is exempt from disclosure, it fails to provide the requester with sufficient information to determine whether the withheld document is blanketly exempt or only exempt-in-part.

When the government litigates over the withholding of material it claims to be exempt, as the result of the holding in Vaughn v. Rosen, 157 U.S. App. D.C. 340, 484 F.2d 820 (1973), cert. denied, 415 U.S. 977 (1974), it is required to itemize the deleted portion of the document correlated with the alleged statutory justification for the withholding. Providing for the preparation of a Vaughn-type index (perhaps at the option and expense of the requester) prior to litigation would avoid unnecessary burdening of the courts with premature suits.

4.

Disclosure of Real Party Seeking Information.

We understand that many commercial enterprises seek information through substituted (nominee) persons. Except in situations where corrupt or otherwise illegal governmental activity is suspected, we contend that parties seeking information should be required to state their true interests.

While not the type of procedure which should be covered

in statutory requirements, AHS contends that part of the difficulty in resolving FOIA disputes is the mere genuine lack of effort at accomodation.

Many federal judges have required as part of their pre-trial orders that discovery disputes must be attempted to be resolved by an actual meeting between the opposing parties prior to the seeking of judicial resolution. A similar approach should be suggested by the Committee Report language of any FOIA reform legislation. A face-to-face meeting among agency program and

FOIA officials and requesters prior to or as a result of an agency appeal on the disputed materials would be advisable.

6.

Time Extensions For Agency Response.

S. 587 contains a provision which would gauge the period of time permitted for an agency response to a FOIA request according to the number of pages encompassed by the request. For each two hundred pages of requested material, sixty additional working days would be given to an agency to respond to a request. Although AHS recognizes that the present 10-day response period may be unrealistic for certain requests it, nevertheless, opposes efforts to revise the time for agency response

to requests. intent of S. 587 to develop an objective test for an alternative time period, although the criterion chosen has certain disad

If revisions are to be made, AHS applauds the

vantages.

The size of dimension of a request is only one aspect of potential difficulty in an agency responding in a timely and responsible fashion. Other problems involve the categories chosen by an agency for storing or retrieving records, the age of the records and the number of officials who have dealt with the records prior to storage.

A response involving a considerable number of documents may have repetitive or similar pieces of information which would require little, if any, close scrutiny by an FOIA officer. In such a case, a ten-day response period is entirely appropriate. In other cases, where each piece of paper must be closely read, the sixty working day period proposed by the bill would permit an FOIA officer to review as little as an average of slightly over three pages per day.

A preferable alternative would permit an agency to request additional time periods for response based on a number of factors such as the location of the records, their age, the

need for close review, etc. Rather than an automatic extension, the use of, for example, a magistrate to determine the propriety of an agency request for an extension of time, would be a better procedure in contested extension requests.

The Freedom of Information Act has provided a window into the operations of our democratic government. AHS and RHH have found that the FOIA has provided a vehicle for the protection of its legal rights and for the vindication of a medical delivery system, the treatment of the disease of alcoholism. The ultimate success of RHH and AHS not only inures to their corporate benefit but also to the benefit of the public at large since the individuals who can now continuously avail themselves of professional and medical services under the Medicare coverage guidelines are in desperate need of responsible treatment for a disease which has a substantially deleterious fiscal and medical impact on our society as a whole.

of the FOIA

to

It is respectfully submitted that any proposals which would substantially change or alter the underlying purposes of the FOIA would do a disservice to both private and public citizens. In our case, justice was served through the responsible use any legislative changes should not undercut the basic purposes of the Act, namely the right of citizens know what their government is doing. In our instance, information secured through the FOIA which was unavailable elsewhere provided an opportunity to change what would have been a disastrous result with far-reaching impact beyond the corporate entities involved. The FOIA should continue to fulfill this laudatory purpose. On behalf of our clients, we thank you for the opportunity to express our views, and we would be delighted to respond to any questions you might have as a result of our testi

mony.

Senator HATCH. Dr. Worthen.

STATEMENT OF DAVID M. WORTHEN, M.D., ASSISTANT CHIEF MEDICAL DIRECTOR FOR ACADEMIC AFFAIRS, VETERANS'

ADMINISTRATION

Dr. WORTHEN. Thank you, Senator Hatch and Mr. Rader. I welcome the opportunity to share my observations with you as you deliberate amendments to the Freedom of Information Act.

I appear before you today as an ophthalmologist, as a former chairman of the FDA Ophthalmic Devices Section, but most importantly as a citizen concerned about fairness and balance in the process of government.

My concern about the Freedom of Information Act falls into three categories. First, the act has permitted the premature release of sensitive expert advisory testimony and discussions of preliminary research data which was detrimental to the process of scientific merit review.

My second concern is that an over attention to the Freedom of Information Act and the required assembling of information has slowed down the process of device review and regulation, thereby denying the public timely access to newly developed devices for visual rehabilitation or care.

Specifically, the other 212 ophthalmic devices, including contact lenses, were put on the back burner for over a year while responses to the Freedom of Information Act requests delayed their review.

My third concern is with the fee waivers for public interest groups which not only allows but may tend to encourage a form of harassment of a Government agency, thereby reducing its efficiency and not allowing it to meet its responsibilities to the public at large.

I will limit my discussion to my experience with the investigation of intraocular lenses beginning in 1975.

A cataract is an opacity of the natural lens inside the eye. When a cataract is removed from a human eye, the ability to focus is lost. Restoration of function can be brought about by the use of glasses, contact lenses, or the implantation of a small plastic lens at the same site as the original natural lens.

Improvements in design, implantation technique, and specific location of the lenses have brought the technology to the point that it is a commonplace operation done throughout the United States. However, in 1975 as the device legislation was in the final stages of preparation, there was a controversy. The lenses were not accepted by all ophthalmologists. Therefore they were subject to FDA study, but specific language was placed in the medical device amendments of the Food, Drug, and Cosmetic Act demanding that the lenses be made reasonably available since they were already in such common use throughout the country.

As the section developed the plans for the study, there was little comment from the public interest groups although full participation by the public member on the section. There was an active and healthy debate of all controversies between members of the ophthalmology profession, Food and Drug Administration staff members and statisticians, representatives of industry, and representatives of organized medical groups.