0567 rev_ext SS 123113

SUPPORTING STATEMENT

Conflict of Interest Disclosure for Nonfederal Government Individuals Who Are Candidates to Conduct Peer Reviews

OMB CONTROL NO. 0648-0567

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary.

This request is a revision and extension of the information collection. A customized Conflict of Interest Disclosure form for NOAA’s Oceanic and Atmospheric Research (OAR) was never used and has been removed from this collection. OAR is using the NOAA-wide form for influential scientific information (ISI) subject to the Peer Review Bulletin (for all such research NOT related to government regulation, which includes peer review of OAR laboratories).

The Office of Management and Budget (OMB) issued government-wide guidance to enhance the practice of peer review of government science documents: OMB’s Final Information Quality Bulletin for Peer Review (“Peer Review Bulletin” or PRB) which establishes minimum peer review standards for influential scientific information that federal agencies intend to disseminate. The PRB also directs federal agencies to adopt or adapt the National Academy of Sciences (NAS) policy for evaluating conflicts of interest when selecting peer reviewers who are not federal government employees (federal employees are subject to federal ethics requirements which address conflict of interest). For peer review purposes, the term “conflict of interest” means any financial or other interest which conflicts with the service of the individual because it could: (1) significantly impair the individual’s objectivity or (2) create an unfair competitive advantage for any person or organization.

NOAA has adapted the NAS policy and developed two confidential conflict of interest disclosure forms which the agency uses to examine prospective reviewers’ potential financial conflicts and other interests that could impair objectivity or create an unfair advantage. One form is for peer reviewers of studies related to government regulation; the second form is for peer reviewers of any other influential scientific information subject to the Peer Review Bulletin. The forms include questions about employment as well as investment and property interests and research funding. Both forms also require the submission of a curriculum vitae (CV).

2. Explain how, by whom, how frequently, and for what purpose the information will be used. If the information collected will be disseminated to the public or used to support information that will be disseminated to the public, then explain how the collection complies with all applicable Information Quality Guidelines.

NOAA is seeking to collect this information from potential peer reviewers (non-government employees) when conducting a peer review pursuant to the PRB, or an OAR laboratory peer review. The number of peer reviews conducted pursuant to the PRB each year will vary, but for illustrative purposes, NOAA currently has fifty peer review plans posted on its Peer Review Agenda, including those completed in the past year, in progress, or pending shortly). The information collected in the conflict of interest disclosure is essential to NOAA’s compliance with the OMB PRB, and helps to ensure that government studies are reviewed by independent, impartial peer reviewers.

NOAA will retain control over the information and safeguard it from improper access, modification, and destruction, consistent with NOAA standards for confidentiality, privacy, and electronic information.  See response to Question 10 of this Supporting Statement for more information on confidentiality and privacy. The information collection is designed to yield data that meet all applicable information quality guidelines. Although the information collected is not expected to be disseminated directly to the public, results may be used in scientific, management, technical or general informational publications. Should NOAA be required to release any of the information, it will be subject to the quality control measures and pre-dissemination review pursuant to Section 515 of Public Law 106-554.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological techniques or other forms of information technology.

The NOAA peer review conflict of interest forms are available in Word, downloadable from the NOAA Office of the Chief Information Officer’s Information Quality Web page: http://www.cio.noaa.gov/services_programs/info_quality.html and fillable on a computer. The format allows the user to electronically complete and sign the form, then email it and his/her CV to the NOAA office conducting the peer review.

4. Describe efforts to identify duplication.

This information collection is specifically required by OMB’s Peer Review Bulletin. Each potential peer reviewer is asked to disclose any potential conflicts with regard to a given study. NOAA will not ask that the potential reviewer complete more than one conflict form per study.

5. If the collection of information involves small businesses or other small entities, describe the methods used to minimize burden.

The information collection involves individuals only.

6. Describe the consequences to the Federal program or policy activities if the collection is not conducted or is conducted less frequently.

If the information collection requirements are not completed, NOAA would be in violation of OMB’s PRB requirements for screening potential peer reviewers for conflicts of interest. Alternatively, the agency would not be able to solicit non-governmental peer reviewers, a practice which would be contrary to the clear intent of the PRB.

7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with OMB guidelines.

NA.

8. Provide information on the PRA Federal Register Notice that solicited public comments on the information collection prior to this submission. Summarize the public comments received in response to that notice and describe the actions taken by the agency in response to those comments. Describe the efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

A Federal Register Notice published on September 17, 2013 (78 57130) solicited comments on this request. No comments were received.

The coordinator of peer reviews from the Center of Independent Experts, which supplies many peer reviewers for NOAA studies related to government regulation, but which has its own form as well, commented:

“The form is generally fine, but the language could be more concise, using bullets for the disclosure requirements.

I am particularly curious about the form's definition of COI that states "conflict of interest applies only to current interests."  Referring to the attached CIE COI disclosure form, note that CIE is concerned about whether impartiality is compromised if a reviewer, and the family of a reviewer, received funding or employment during the past three years”.

NOAA’s (contacts from NMFS and OAR, and the PRA clearance officer) response was to re-review our form and determine that the format and content were reasonably concise, and that the CIE form (included as supplementary document), in comparison, did not break down the types of conflict at all.

On the issue of “past three years”, we consulted with the NOAA GC who had developed the original information collection and forms, which are based on the NAS conflict of interest disclosure policy (also included as a supplementary document). The policy defines “current” in these words: “The term "conflict of interest" applies only to current interests. It does not apply to past interests that have expired, no longer exist, and cannot reasonably affect current behavior. Nor does it apply to possible interests that may arise in the future but do not currently exist, because such future interests are inherently speculative and uncertain. For example, a pending formal or informal application for a particular job is a current interest, but the mere possibility that one might apply for such a job in the future is not a current interest.”

The two Line Office contacts expressed concern that if we actually changed the definition to include the past three years, this action might eliminate a significant number of potential reviewers. We decided to continue to use the NAS definition of “current”.

OAR, during recent laboratory reviews, welcomed comment on clarity of the instructions and accuracy of the burden, and received no comments.

9. Explain any decisions to provide payments or gifts to respondents, other than remuneration of contractors or grantees.

No payment or gift will be made to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for assurance in statute, regulation, or agency policy.

NOAA’s Policy on Conflicts of Interest for Peer Review subject to the OMB Peer Review Bulletin states that, except as provided for in the Policy, specific conflict of interest information obtained by NOAA – or the entity commissioned by NOAA to manage the peer review process – from: 1) the NOAA conflict of interest disclosure form, 2) amended disclosures, and 3) the public and other sources will be held in confidence by NOAA.  Access to such information within NOAA will be limited to those offices whose proper business requires access to that information.  Such information will not be released by NOAA, or the entity commissioned by NOAA to manage the peer review process, except with the approval of the individual to whom the information pertains, unless release is required by law. As specified in NOAA’s Policy on Conflicts of Interest, the exception to the non-disclosure policy is the public disclosure of the names of reviewers and their organizational affiliations. For peer reviewers of highly influential scientific assessments, the reviewer’s credentials and relevant experience must also be disclosed, as required by the PRB. Although the OAR laboratory reviews are not subject to the PRB, the same procedures are followed, but with the disclosure of the reviewer’s credentials and relevant experience not applicable for these reviews.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

There are no questions of this type in the forms. They ask only about financial, investment, property, employment, or research funding interests in the study to be peer reviewed.

12. Provide an estimate in hours of the burden of the collection of information.

Estimated Number of Respondents: 321 (300 for the NMFS peer reviews and 21 for the OAR lab peer reviews).

Estimated Time Per Response: 30 minutes.

Estimated Total Annual Burden Hours: 160.5 (161).

13. Provide an estimate of the total annual cost burden to the respondents or record-keepers resulting from the collection (excluding the value of the burden hours in Question 12 above).

There are no recordkeeping/reporting costs to the respondents, as they submit their forms via email.

14. Provide estimates of annualized cost to the Federal government.

Estimated time for government staff (GS 13) to review each completed conflict of interest form: 30 minutes.

Estimated total annual government staff hours: 161 (30 minutes x 321 forms).

Estimated annual cost to federal government (161 hours x $40.00/hr): $6,440.00.

15. Explain the reasons for any program changes or adjustments.

Program change with no burden change: The adaptation of the form for general scientific and technical studies for OAR lab use, in the last submission, was not used, and OAR continued to use the NOAA form.

Adjustment: There was an adjustment to the numbers of forms estimated for OAR lab reviews. This added 9 responses and 5 hours.

16. For collections whose results will be published, outline the plans for tabulation and publication.

The collection will not be published.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.

NA.

18. Explain each exception to the certification statement.

NA.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

This collection does not employ statistics.

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