COMMENT BY: American Association of Physicians and Surgeons
SUBJECT: In favor of proposed revision to OMB Circular A-110
DATE: February 1, 1999

Dear Mr. Charney:

This filing is in reference to the OMB notice in the Federal Register of February 4, 1999, where you requested public comments on your proposed revision to OMB Circular A-11O, promulgated pursuant to Omnibus Appropriations Act for FY 1999 (PL 105-277) (the Act

I am a practicing internist from Tucson, Arizona and serve as the Executive Director of the Association of American Physicians & Surgeons, Inc. ( AAPS ) . AAPS represents thousands of physicians nationwide in upholding the traditional patient-physician relationship. Founded in 1943, AAPS is a non-profit Indiana corporation. AAPS frequently testifies before Congress and has successfully participated in landmark medical litigation like United States v. Rutgard, 116 F.3d 1270 (9th Cir. 1997). Many of our members (myself included) have also participated in federally funded research.

AAPS strongly supports public access to federally-funded research data in order to promote medical advances.

COMMENTS:

The proposed rule contains arbitrary limitations on public access in violation of the express requirements of the Act. First, the proposed rule capriciously limits public access to data relating to published research findings that were used by the Federal Government in developing policy or rules. Such limitations directly contravene the Act. Second, the proposed rule arbitrarily imposes additional costs on the public by including charges for the recipient and subrecipients, in addition to the agency s own reasonable cost, in violation of the Act.

I. THE ARBITRARY LIMITATIONS OF PUBLICATION AND RULEMAKING.

The Act expressly mandates an amendment to Section _.36 of OMB Circular A-11O:

to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.

This requirement thereby applies to all data produced under a federal award. The public paid for such data, and is entitled to access it. AAPS physicians need access to the raw research data in order to conduct valuable research for the benefit of the public. Limiting such access would restrain medical discoveries, and would encourage manipulation of the data by the narrow interests in control.

The proposed rule, however, capriciously limits public access to data relating to published research findings that were used by the Federal Government in developing policy or rules. These limitations contravene the Act, and would harm the public interest. Often federally-funded data are withheld from publication because the data are contrary to the financial interests of the researching entity. Indeed, data withheld from publication are typically more important and more controversial than the data published. Likewise, data not used for rulemaking or policy decisions are often extremely important to the public in demonstrating the need for rulemaking.

Obtaining data through FOIA is a slow process. If this process is delayed until after publications are released concerning the data, then the public will be deprived of an objective and timely review of the underlying data. There is no legitimate interest in a recipient of a federal grant to withhold its data from the public until long after publication. The only motivation for such withholding would be the illegitimate purpose of preventing independent and timely review of the data. The proposed rule is fatally defective in allowing such withholding.

These limitations on public access to data must be removed. Removal of these limitations will enable the public to obtain prompt access to federally-funded data as required by the Act.

II. THE ARBITRARY ADDITION OF RECIPIENT CHARGES.

The Act expressly requires that:

if the agency obtaining the data does so solely at the request of a private party, the agency may authorize a reasonable user fee equaling the incremental cost of obtaining the data .

The Act thereby permits the agency to charge only a reasonable user fee equal to its incremental cost of obtaining the data, and only if the agency obtaining the data does so solely at the request of a private party. No additional charges may be imposed for the benefit of the recipient and subrecipients of the federal grant, and no additional charges may be included for data that the agency has already obtained.

The proposed rule, however, categorically and capriciously increases access costs to include expenses of the recipient and subrecipients of the federal grant. Under the Act, the public has the same rights to the (non-exempted) data as the agency, regardless of the expenses of the recipient and subrecipients. If the terms of the federal award entitle the agency to access the data without extra charge, or if the agency already obtained the data for another requester, then the public is entitled to the data without additional expenses charged by the re