Coordinating Committee

: The Outer Continental Shelf (OCS) Lands Act (OCSLA), as amended (43 U.S.C. 1331 et seq. and 43 U.S.C. 1801 et seq. ), authorizes the Secretary of the Interior to prescribe rules and regulations necessary for the administration of the leasing provisions of that Act related to mineral resources on the OCS. Such rules and regulations will apply to all operations conducted under a lease, right-of-way, or a right-of-use and easement. Operations on the OCS must preserve, protect, and develop oil and natural gas resources in a manner that is consistent with the need to make such resources available to meet the Nation’s energy needs as rapidly as possible; to balance orderly energy resource development with protection of human, marine, and coastal environments; to ensure the public a fair and equitable return on the resources of the OCS; and to preserve and maintain free enterprise competition.

improve these practices, processes, or systems.
11. Are there current practices, processes, or systems that could be used to exchange information between supply chain stakeholders or with FDA to respond to requests to verify the lot number, expiration date, and other indices of identity assigned to a product by the manufacturer or repackager (i.e., requests for verification of suspect product)?Are these practices, processes, or systems effective?If not, please provide recommendations to improve these practices, processes, or systems.
12. Are there current practices, processes, or systems that could be used for providing information in response to requests from FDA or other appropriate Federal or State officials in the event of a recall or for the purpose of investigating a suspect or illegitimate product?Are these practices, processes, or systems effective?If not, please provide recommendations to improve these practices, processes, or systems.
Question related to capturing information that has not necessarily been addressed by the previous questions: 13. Are there other considerations related to standards for the interoperable exchange of information for tracing of human, finished, prescription drugs that have not been addressed by the previous questions?Please provide any additional information that you think could be helpful for the Agency to consider as it implements these provisions of the DSCSA.

III. Submission of Comments
Interested persons may submit either electronic comments regarding this document to http://www.regulations.govor written comments to the Division of Dockets Management (see ADDRESSES).It is only necessary to send one set of comments.Identify comments with the docket number found in brackets in the heading of this document.Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov.
days in advance of the meeting.Interested individuals and representatives or organizations should submit a letter of intent, a brief description of the organization represented, and a written copy of their oral presentation in advance of the meeting.Only one representative of an organization will be allowed to present; oral comments and presentations will be limited to a maximum of 5 minutes.Printed and electronic copies are requested for the record.In addition, any interested person may file written comments with the Committee by forwarding their statement to the contact person listed on this notice.The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.Because of time constraints for the meeting, oral comments will be allowed on a first-come, first-serve basis.
Members of the public who would like to receive email notification about future DMICC meetings should register for the listserv available on the DMICC Web site, www.diabetescommittee.gov.
inherently Federal or where the statute establishing the existing program does not authorize the type of participation sought by the tribe.However, a tribe (or tribes) need not be identified in the authorizing statutes in order for a program or element to be included in a self-governance funding agreement.While general legal and policy guidance regarding what constitutes an inherently Federal function exists, the non-BIA Bureaus will determine whether a specific function is inherently Federal on a case-by-case basis considering the totality of circumstances.In those instances where the tribe disagrees with the Bureau's determination, the tribe may request reconsideration from the Secretary.
Subpart G of the self-governance regulations found at 25 CFR part 1000 provides the process and timelines for negotiating self-governance funding agreements with non-BIA bureaus.

Response to Comments
No comments were received.

A. Eligible Bureau of Land Management (BLM) Programs
The BLM carries out some of its activities in the management of public lands through contracts and cooperative agreements.These and other activities, depending upon availability of funds, the need for specific services, and the self-governance tribe's demonstration of a special geographic, culture, or historical connection, may also be available for inclusion in selfgovernance funding agreements.Once a tribe has made initial contact with the BLM, more specific information will be provided by the respective BLM State office.
Some elements of the following programs may be eligible for inclusion in a self-governance funding agreement.This listing is not all-inclusive, but is representative of the types of programs that may be eligible for tribal participation through a funding agreement.

B. Eligible Bureau of Reclamation Programs
The mission of the Bureau of Reclamation (Reclamation) is to manage, develop, and protect water and related resources in an environmentally and economically sound manner in the interest of the American public.To this end, most of Reclamation's activities involve the construction, operation and maintenance, and management of water resources projects and associated facilities, as well as research and development related to its responsibilities.Reclamation water resources projects provide water for agricultural, municipal and industrial water supplies; hydroelectric power generation; flood control, enhancement of fish and wildlife habitats; and outdoor recreation.
Components of the following water resource projects listed below may be eligible for inclusion in a selfgovernance annual funding agreement.

D. Eligible National Park Service (NPS) Programs
The National Park Service administers the National Park System, which is made up of national parks, monuments, historic sites, battlefields, seashores, lake shores and recreation areas.The National Park Service maintains the park units, protects the natural and cultural resources, and conducts a range of visitor services such as law enforcement, park maintenance, and interpretation of geology, history, and natural and cultural resources.Some elements of the following programs may be eligible for inclusion in a self-governance funding agreement.This list below was developed considering the proximity of an identified self-governance tribe to a national park, monument, preserve, or recreation area and the types of programs that have components that may be suitable for contracting through a self-governance funding agreement.This list is not all-inclusive, but is representative of the types of programs which may be eligible for tribal participation through funding agreements.
Elements of Programs That May Be Eligible for Inclusion in a Self-Governance Funding Agreement

E. Eligible Fish and Wildlife Service (Service) Programs
The mission of the Service is to conserve, protect, and enhance fish, wildlife, and their habitats for the continuing benefit of the American people.Primary responsibilities are for migratory birds, endangered species, freshwater and anadromous fisheries, and certain marine mammals.The Service also has a continuing cooperative relationship with a number of Indian tribes throughout the National Wildlife Refuge System and the Service's fish hatcheries.Any selfgovernance tribe may contact a National Wildlife Refuge or National Fish Hatchery directly concerning participation in Service programs under the Tribal Self-Governance Act.This list is not all-inclusive, but is representative of the types of Service programs that may be eligible for tribal participation through an annual funding agreement.
1 5. Environmental Contaminants Program.Conduct activities associated with identifying and removing toxic chemicals, to help prevent harm to fish, wildlife and their habitats.The activities required for environmental contaminant management may include, but are not limited to, analysis of pollution data, removal of underground storage tanks, specific cleanup activities, and field data gathering efforts.
6. Wetland and Habitat Conservation Restoration.Provide services for construction, planning, and habitat monitoring and activities associated with conservation and restoration of wetland habitat.
7. Fish Hatchery Operations.Conduct activities to recover aquatic species listed under the Endangered Species Act, restore native aquatic populations, and provide fish to benefit Tribes and National Wildlife Refuges that may be eligible for a self-governance funding agreement.Such activities may include, but are not limited to: Tagging, rearing and feeding of fish, disease treatment, tagging, and clerical or facility maintenance at a fish hatchery.
8. National Wildlife Refuge Operations and Maintenance.Conduct activities to assist the National Wildlife Refuge System, a national network of lands and waters for conservation, management and restoration of fish, wildlife and plant resources and their habitats within the United States.Activities that may be eligible for a selfgovernance funding agreement may include, but are not limited to: Construction, farming, concessions, maintenance, biological program efforts, habitat management, fire management, and implementation of comprehensive conservation planning.

Locations of Refuges and Hatcheries With Close Proximity to Self-Governance Tribes
The Service developed the list below based on the proximity of identified self-governance tribes to Service facilities that have components that may be suitable for contracting through a self-governance funding agreement.

F. Eligible U.S. Geological Survey (USGS) Programs
The mission of the USGS is to collect, analyze, and provide information on biology, geology, hydrology, and geography that contributes to the wise management of the Nation's natural resources and to the health, safety, and well-being of the American people.This information is usually publicly available and includes maps, data bases, and descriptions and analyses of the water, plants, animals, energy, and mineral resources, land surface, underlying geologic structure, and dynamic processes of the earth.The USGS does not manage lands or resources.Selfgovernance tribes may potentially assist the USGS in the data acquisition and analysis components of its activities.

G. Eligible Office of the Special Trustee for American Indians (OST) Programs
The Department of the Interior has responsibility for what may be the largest land trust in the world, approximately 56 million acres.OST oversees the management of Indian trust assets, including income generated from leasing and other commercial activities on Indian trust lands, by maintaining, investing and disbursing Indian trust financial assets, and reporting on these transactions.The mission of the OST is to serve Indian communities by fulfilling Indian fiduciary trust responsibilities.This is to be accomplished through the implementation of a Comprehensive Trust Management Plan (CTM) that is designed to improve trust beneficiary services, ownership information, management of trust fund assets, and self-governance activities.
A tribe operating under selfgovernance may include the following programs, services, functions, and activities or portions thereof in a funding agreement: 1. Beneficiary Processes Program (Individual Indian Money Accounting Technical Functions).
2. Appraisal Services Program.Tribes/ consortia that currently perform these programs under a self-governance funding agreement with the Office of Self-Governance may negotiate a separate memorandum of understanding (MOU) with OST that outlines the roles and responsibilities for management of these programs.
The MOU between the tribe/ consortium and OST outlines the roles and responsibilities for the performance of the OST program by the tribe/ consortium.If those roles and responsibilities are already fully articulated in the existing funding agreement with the BIA, an MOU is not necessary.To the extent that the parties desire specific program standards, an MOU will be negotiated between the tribe/consortium and OST, which will be binding on both parties and attached and incorporated into the BIA funding agreement.
If a tribe/consortium decides to assume the operation of an OST program, the new funding for performing that program will come from OST program dollars.A tribe's newlyassumed operation of the OST  ), authorizes the Secretary of the Interior to prescribe rules and regulations necessary for the administration of the leasing provisions of that Act related to mineral resources on the OCS.Such rules and regulations will apply to all operations conducted under a lease, right-of-way, or a right-ofuse and easement.Operations on the OCS must preserve, protect, and develop oil and natural gas resources in a manner that is consistent with the need to make such resources available to meet the Nation's energy needs as rapidly as possible; to balance orderly energy resource development with protection of human, marine, and coastal environments; to ensure the public a fair and equitable return on the resources of the OCS; and to preserve and maintain free enterprise competition.
The OCSLA requires open and nondiscriminatory access to oil and gas pipelines.The OCSLA provides the Secretary of the Interior the authority to issue and enforce rules to assure open and nondiscriminatory access to pipelines.These regulations provide a mechanism for entities who believe they have been denied open and nondiscriminatory access to pipelines on the OCS.The BSEE established a process, via the subject regulations, to submit complaints alleging denial of access or discriminatory access for a shipper transporting oil or gas production from Federal leases on the OCS.The complaint should include certain minimal data in order for BSEE to begin an investigation.Upon completion of an investigation, BSEE will propose a remedial action.
The Independent Offices Appropriations Act (31 U.S.C. 9701), the Omnibus Appropriations Bill (Pub.L. 104-133, 110 Stat. 1321, April 26, 1996), and OMB Circular A-25, authorize Federal agencies to recover the full cost of services that confer special benefits.Under the Department of the Interior's implementing policy, BSEE is required to charge fees for services that provide special benefits or privileges to an identifiable non-Federal recipient above and beyond those which accrue to the public at large.Regulations at § § 291.106(b) and 291.108 require a nonrefundable processing fee of $7,500 that a shipper must pay when filing a complaint to BSEE.
Regulations implementing these responsibilities are among those delegated to BSEE.Responses are voluntary but are required to obtain or retain a benefit.No questions of a sensitive nature are asked.The BSEE protects information considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and DOI's implementing regulations (43 CFR 2), and under regulations at 30 CFR 250.197,Data and information to be made available to the public or for limited inspection, 30 CFR Part 252, OCS Oil and Gas Information Program.
The BSEE uses the submitted information to initiate a more detailed investigation into the specific circumstances associated with a complainant's allegation of denial of access or discriminatory access to pipelines on the OCS.The complaint information will be provided to the alleged offending party.The BSEE may request additional information upon completion of the initial investigation.
Frequency: On occasion.Description of Respondents: Potential respondents include OCS Federal oil, gas, or sulphur lessees and/or operators.
Estimated Reporting and Recordkeeping Hour Burden: The estimated annual hour burden for this information collection is a total of 51 hours.The following chart details the individual components and estimated hour burdens.In calculating the burdens, we assumed that respondents perform certain requirements in the normal course of their activities.We consider these to be usual and customary and took that into account in estimating the burden.