General. An OPDIV/STAFFDIV responsible for carrying out a specific action is responsible for preparation of an EIS, if one is required. The final text of an EIS will be prepared by the responsible official after comments on the draft statement have been addressed and received full consideration in the OPDIV/STAFFDIV's decision-making process.

Cooperation With Other Federal Agencies. In cases in which HHS participates with other Federal agencies in a proposed action, one agency will be the lead agency and will supervise preparation of an EIS if one is required. A Memorandum of Understanding among all involved agencies may be useful in summarizing the relative responsibilities of all involved agencies. Lead agency responsibility should be determined in accordance with 40 CFR 1501.5.

HHS will act as a cooperating agency if requested. HHS may request to be designated as a cooperating agency if proposed actions may affect areas of HHS responsibility. As a cooperating agency, HHS will comply with the procedures in 40 CFR 1501.6(b) to the extent possible, depending on program commitments and the availability of funds and personnel.

Within the Department, lead or cooperating agency responsibility will be exercised by the OPDIV/STAFFDIV that is responsible for the subject matter of the proposed action. If a proposed action affects more than one OPDIV/STAFFDIV, the Secretary will designate one of the OPDIVs/STAFFDIVs to be responsible for coordinating the preparation of required environmental documentation.

Cooperation With States. In cases in which an OPDIV/STAFFDIV participates with state and local governments in a proposed action, the OPDIV/STAFFDIV is responsible for preparing an EIS. However, a state agency may jointly prepare the statement if it has state-wide jurisdiction and HHS participates in its preparation, including soliciting the views of other state or Federal agencies affected by the statement.

Proposals for Legislation. A legislative EIS must be prepared for any legislative proposal developed by HHS which would significantly affect the quality of the human environment. A legislative EIS shall be submitted to Congress at the time the legislation is proposed to Congress or up to 30 days afterwards. Except as provided in 40 CFR ' 1506.8, a draft EIS shall accompany a legislative proposal. A scoping process is not required for a legislative EIS.

All reasonable alternatives (including no action) are rigorously explored and objectively evaluated,

There is balancing of environmental impacts with the OPDIV's/ STAFFDIV's objective in choosing an appropriate course of action;

Appropriate mitigation measures are included in the proposed action or alternatives;

Diligent efforts are made to provide an opportunity for the public to participate in the environmental review process;

Comments on a draft EIS are carefully assessed and considered; and

The preferred alternative is the alternative which the OPDIV/STAFFDIV believes would fulfill its statutory mission and responsibilities giving consideration to economic, environmental, technical and other factors.

OPDIV/STAFFDIV Action. Except as provided at 40 CFR '' 1506.1 and 1506.10(b) and this section, no HHS OPDIV/STAFFDIV decision on the proposed action shall be made or recorded until at least 30 days after the publication by EPA of notice that the particular EIS has been filed with EPA. If the subject of a final statement is also the subject of a regulation published in the Federal Register, this requirement may be met by simultaneous publication of the regulation and of a Notice of Availability of the final statement and the Record of Decision, provided that the regulation becomes effective no sooner than 30 days after the date of publication, unless such regulation is subject to formal internal appeal. For regulations subject to formal internal appeal, the period for formal appeal of the decision and the 30 day period may run concurrently.

Record of Decision. A Record of Decision (ROD) shall be prepared by the responsible official when an HHS organization decides to take action on a proposal covered by an EIS. See 40 CFR ' 1505.2. No action shall be taken until the decision has been made public, except as provided at 40 CFR '' 1500.6 and 1506.l. The contents of a ROD are specified in 30-50-65. (See further discussion in 30-50-65).

Emergency Actions. There are certain HHS organization actions which, because of their immediate importance to the public health, make adherence to the requirements of the CEQ regulations and this section concerning minimum periods of public review impractical. Compliance with the requirements for environmental analysis under NEPA is impossible where emergency circumstances require immediate action to safeguard the public health. For such actions, the responsible official shall consult with the CEQ about alternative arrangements before the action is taken, or after the action is taken if time does not permit prior consultation with CEQ. OPDIVs/STAFFDIVs shall, in accordance with 40 CFR ' 1506.11, limit such arrangements to actions necessary to control the immediate impacts of the emergency. Other actions remain subject to NEPA review. An OPDIV/STAFFDIV shall document, including publishing a notice in the Federal Register, an emergency action covered by this paragraph within 30 days after such action occurs. The documentation shall identify any adverse impacts from the actions taken; any further mitigation that is necessary; and any NEPA documents that may be required.

Monitoring. As described in 40 CFR ' 1505.3, an OPDIVISTAFFDIV may provide for monitoring to ensure that its decisions, any mitigating measures, and other conditions are carried out.