March 22, 1999

Associate Director for Science, CDC

CDC/ATSDR Comments to Proposed Revision of OMB Circular A-110

Charlie Gale, Director, Office of Grants Management, OS
John Fanning, Privacy Advocate, OS

The CDC and ATSDR offer the attached comments to the proposed revision to OMB Circular A-110, "Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and other Non-Profit Organizations." These comments represent the agencies' primary concerns with the proposed revision and provide recommendations for OMB in finalizing the NPRM. The use of the terms grants or grantees is intended to include cooperative agreements and cooperative agreement holders.

Generally speaking, this agency is very supportive of data sharing, particularly among collaborators and other researchers. Nevertheless, data sharing must be done with the utmost regard for the privacy of study participants and in a manner that will neither deter nor harm the research. In limiting grantee data to that which is published and relied upon in developing Federal rules or policy, the revised amendment appropriately allows for the dissemination of pertinent data to non-researcher stakeholders (i.e. those entities and individuals whose activities are being regulated by the Federal government). It is critical that the term policy is narrowly defined to include only those matters that require compliance by those stakeholders.

Although the agencies will apply the FOIA exemptions to this data in responding to requests for data under the Circular's procedures, CDC/ATSDR remain concerned about the impact that the proposed revision will have on researchers in enlisting study participants given their fears about identifiable data about themselves being shared with a Federal agency and at least potentially subject to public disclosure (certainly no guarantee of confidentiality can be made to participants).

It cannot be overstated that record retention and the attendant problems of storage and cost remain of great concern to CDC/ATSDR. In fiscal year 1998, 777 awards totally $301 million were made to organizations subject to the A-110 Circular. Requesting this data from grantees, processing it for FOIA release and then storing it will place an enormous burden on CDC/ATSDR administratively as well as on grantees, for which reasonable fees that represent the incremental costs of providing the data will not begin to cover. Nevertheless, at the very least CDC/ATSDR should be allowed to retain those fees and not have to return them to the general treasury.

Finally, because CDC/ATSDR have no existing mechanisms for ensuring grantee compliance with the FOIA request, the agencies may encounter noncompliance resulting in failure to provide the requested data. This may in turn lead to litigation and place the agencies in an adversarial position with their grantees. It's unclear how to resolve this issue.

Dixie E. Snider, Jr., M.D., M.P.H.

Attachment

cc:
Paula Kocher
Lynn Armstrong
John Williams
Mary Armstrong

COMMENTS FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION And THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY REGARDING OMB'S NOTICE OF PROPOSED RULEMAKING TO AMEND CIRCULAR A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and other Non-Profit Organizations."

The proposed amendment reads as follows:

(c)The Federal Government has the right to (1) obtain, reproduce, publish, or otherwise use the data first produced under an award, and (2) authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes. In addition, in response to a Freedom of Information Act (FOIA) request for data relating to published research findings produced under an award that were used by the Federal Government in developing policy or rules, the Federal awarding agency shall, within a reasonable time, obtain the requested data so that they can be made available to the public through the procedures established under the FOIA. If the Federal awarding agency obtains the data solely in response to a FOIA request, the agency may charge the requestor a reasonable fee equaling the full incremental cost of obtaining the data. This fee should reflect costs incurred by the agency, the recipient, and applicable subrecipients. This fee is in addition to any fees the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).

CDC/ATSDR offer the following comments regarding the proposed amendment:

1. CDC/ATSDR agree with OMB that the proposed amendment should apply only to grantee's data when that data is related to published research findings. For the sake of clarity, OMB should define publication to be when the grantee's research findings are made publicly available through print or electronic means. CDC/ATSDR further agree with OMB that only grantee data that was relied upon in developing Federal rules or policy come within the scope of the proposed amendment. In that regard, CDC/ATSDR recommend that the term policy be defined to require more than agency guidance to the public. Agency "policy" are those matters that are legally binding and require adherence by specified persons or entities. For instance, pursuant to statute, providers who participate in the Vaccine for Children (VFC) program must adhere to resolutions establishing the VFC immunization schedule that are approved by CDC's Advisory Committee for Immunization Practices and as such these schedules would be a policy for the purpose of the amendment. However, policy should not be defined to include guidelines and recommendations issued by CDC in its Morbidity and Mortality Weekly Report or "best practices" guidance documents provided to grantees, consensus findings on medical practices or generally speaking, advice from one of CDC's or ATSDR's advisory committees.

2. CDC/ATSDR recommends that the proposed amendment require that the rule or policy implicated has explicitly and directly relied on the grantee data.

3. OMB should clarify that the circular applies only to data produced as a direct result of the award. Accordingly, awards which are intended for purposes other than data collection and analysis that nonetheless affect data collection, would not be subject to FOIA compliance, e.g. CDC/ATSDR grant funds that are provided to train a student who is assigned to a research project which is not funded in whole or in part by the Federal government.

4. OMB should indicate that the requirements of the proposed amendment only apply to grants awarded after the final amendment is issued.

5. CDC/ATSDR make two recommendations regarding record retention. The OMB Circular A-110 requires grantees to retain data for three years following the submission of the final financial report. Access to that data under these FOIA procedures should only apply up through this time period. Agencies should not be required to obtain data from the grantee that the grantee no longer legally must maintain. Secondly, because CDC will have to retain enormous amounts of data for between 2 to 6 years per FOIA request, it is recommended that this FOIA requirement be waived so that data can be returned to the grantee once the data has been provided.

6. CDC/ATSDR recommend that OMB provide further guidance as to how to determine a reasonable fee, how the grantee is to be reimbursed and whether the agencies can retain these reasonable fees. Fees over the agency's billing threshold should be paid in advance and should reflect grantee costs as well.

7. CDC/ATSDR recommend that OMB provide further guidance as to the course of action an agency may take for grantee non-compliance given the fact that the agency remains legally responsible for FOIA compliance.