Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 70765 

8. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001) because it is not a significant 

regulatory action as defined in 

Executive Order 12866. 

9. National Technology Transfer 

Advancement Act 

EPA approves state programs as long 

as they met criteria required by RCRA, 

so it would be inconsistent with 

applicable law for EPA, in its review of 

a state program, to require the use of any 

particular voluntary consensus standard 

in place of another standard that meets 

requirements of RCRA. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply to this rule. 

10. Executive Order 12988 

As required by section 3 of Executive 

Order 12988 (61 FR 4729, February 7, 

1996), in issuing this rule, EPA has 

taken the necessary steps to eliminate 

drafting errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct. 

11. Executive Order 12630: Evaluation 

of Risk and Avoidance of Unanticipated 

Takings 

EPA has complied with Executive 

Order 12630 (53 FR 8859, March 15, 

1988) by examining the takings 

implications of the rule in accordance 

with the Attorney General’s 

Supplemental Guidelines for the 

Evaluation of Risk and Avoidance of 

Unanticipated Takings issued under the 

Executive Order. 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Indian lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements. 

Authority: This action is issued under the 

authority of sections 2002(a), 3006, and 

7004(b) of the Solid Waste Disposal Act as 

amended, 42 U.S.C. 6912(a), 6926, 6974(b). 

Dated: November 9, 2005. 

Margaret M. Guerriero, 

Acting Regional Administrator, Region 5. 

[FR Doc. 05–23213 Filed 11–22–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

42 CFR Part 121 

RIN 0906AA62 

Organ Procurement and 

Transplantation Network 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This notice sets forth the 

Secretary’s proposal to include 

intestines within the definition of 

organs covered by the rules governing 

the operation of the Organ Procurement 

and Transplantation Network. The 

Secretary further proposes a 

corresponding change to the definition 

of human organs covered by section 301 

of the National Organ Transplant Act, as 

amended. 

DATES: To be considered, comments on 

this proposed rule must be submitted by 

January 23, 2006. Subject to 

consideration of the comments 

submitted, the Department intends to 

publish final regulations. 

ADDRESSES: You may submit comments, 

identified by RIN 0906AA62, by any of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.hrsa.gov/. Follow the instructions 

for submitting comments on the Agency 

Web site. 

• E-mail: jburdick@hrsa.gov. Include 

RIN 0906AA62 in the subject line of the 

message. 

• Fax: 301–594–6095. 

• Mail: Jim Burdick, M.D., Director, 

Division of Transplantation, Healthcare 

Systems Bureau, Health Resources and 

Services Administration (HRSA), 5600 

Fishers Lane, Room 12C–06, Rockville, 

Maryland 20857. 

• Hand Delivery/Courier: Jim 

Burdick, M.D., Director, Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Room 12C–06, Rockville, 

Maryland 20857. 

Instructions: All submissions received 

must include the agency name and 

Regulatory Information Number (RIN) 

for this rulemaking. All comments 

received will be posted without change 

to http://www.hrsa.gov/, including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to the Division 

of Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Room 12C–06, Rockville, 

Maryland 20857 weekdays (Federal 

holidays excepted) between the hours of 

8:30 a.m. and 5 p.m. To schedule an 

appointment to view public comments, 

phone (301) 443–7757. 

FOR FURTHER INFORMATION CONTACT: Jim 

Burdick, M.D. at the above address; 

telephone number (301) 443–7577. 

SUPPLEMENTARY INFORMATION: 

Adding Intestines to the Definition of 

Organs Covered by the Rules Governing 

the Operation of the Organ 

Procurement and Transplantation 

Network (OPTN) 

Based upon a review of intestinal 

transplants, the Secretary believes that 

intestines should now be included 

within the definition of organs covered 

by the rules governing the operation of 

the OPTN (42 CFR part 121) (hereinafter 

the final rule). This notice sets forth the 

history of intestinal transplants, the 

factors that have persuaded the 

Department of the advisability of 

including intestines within the ambit of 

the regulations governing the operation 

of the OPTN, and the anticipated 

consequences of this proposal. 

The first successful intestinal 

transplant was performed in 1989. 

Intestinal transplantation may be 

considered for patients with irreversible 

intestinal failure due to surgery, trauma, 

or acquired or congenital disease who 

cannot be managed through the 

intravenous delivery of nutrients, also 

referred to as total parenteral nutrition 

(TPN). Although intestinal transplants 

have been performed for years, 

considerable morbidity and mortality 

have limited widespread clinical use. 

Complications are frequent and include 

acute and chronic rejection, 

lymphoproliferative disease, and serious 

infections such as cytomegalovirus 

disease. For patients who received 

intestinal transplants in the United 

States from January 2000 through June 

2002, one-year graft and patient survival 

rates were 67 percent and 81 percent 

respectively for adults, and 58 percent 

and 65 percent respectively for pediatric 

recipients. Despite the shortcomings, 

the number of candidates for intestinal 

transplants and the number of intestinal 

70766 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 

transplants performed annually is 

increasing. 

The OPTN first adopted voluntary 

intestinal organ allocation policies and 

began to maintain a list of patients 

waiting for intestinal transplants in 

1993. On December 31, 1993, only 43 

candidates were listed on the intestinal 

transplant waiting list, compared to 169 

candidates on this list on October 24, 

2003. The number of intestinal 

transplants performed annually has 

more than tripled from 34 transplants in 

1993 to 109 transplants in 2002. 

However, the volume of transplants per 

transplant center is relatively small. Ten 

transplant centers performed one or 

more intestinal transplants in 2002; only 

five of these centers performed ten or 

more transplants. Overall median 

waiting time was 319 days for patients 

added to the intestinal transplant 

waiting list in 2001. 

According to the OPTN, intestinal 

organ allocation may include the 

stomach, small and/or large intestine, or 

any portion of the gastrointestinal tract 

as determined by the medical needs of 

individual patients (OPTN Policy 3.11). 

OPTN voluntary policies are available at 

http://www.optn.org/policiesandbylaws/ 

policies.asp. In addition to allocation for 

isolated intestinal transplants, the 

OPTN addresses allocation of the liverintestine combination and multiple 

organs. 

The nature of the regulatory 

framework governing the operation of 

the OPTN underlies the importance of 

including intestines within the 

definition of organs covered by the final 

rule. Under the final rule, the OPTN 

must submit proposed policies for 

review and approval by the Secretary. 

42 CFR 121.4. Upon consideration of 

public comments on proposed policies 

that are considered significant, the 

Secretary will determine whether to 

make such proposed policies 

enforceable in accordance with § 121.10 

of the final rule. Any transplant hospital 

that fails to comply with any allocation 

policy approved as enforceable by the 

Secretary under this process will be 

subject to the enforcement sanctions 

delineated in § 121.10 of the rule, 

including termination from the 

Medicare and Medicaid programs. 

The Secretary is legally obliged, as 

part of his responsibilities in 

administering the Medicare and 

Medicaid programs, to require hospitals 

that transplant organs to comply with 

the rules and requirements of the OPTN 

as a condition of their participation in 

Medicare and Medicaid. 42 U.S.C. 

1320b–8(a)(1)(B). Because intestines are 

not included within the final rule’s 

definition of organs, the Secretary 

cannot currently make any intestinal 

allocation policy enforceable. If 

intestines are added as covered organs 

under the final rule as proposed here, 

the Secretary could take appropriate 

enforcement actions against a transplant 

hospital for failing to comply with the 

OPTN’s intestinal allocation policy if 

such a policy has been approved as 

enforceable by the Secretary under the 

process outlined above. This 

enforcement authority is particularly 

significant given that many recipients of 

transplanted intestines receive such 

organs together with other organs 

covered under the final rule. It is 

necessary to ensure that intestinal organ 

allocation, whether pertaining to 

isolated intestinal transplants or 

combined/multi-organ transplants, is 

consistent with the goal of an equitable 

national system for organ allocation, as 

described in the final rule. Enforcing 

allocation for organs currently covered 

under the final rule, such as livers, 

would be difficult in instances in which 

intestines are transplanted together with 

such organs if intestinal allocation is not 

subject to the Secretary’s enforcement 

authority. 

As the field of intestinal 

transplantation evolves, it will become 

more critical that intestinal organ 

allocation keeps pace with advances in 

the field; that policy development 

include performance indicators to assess 

whether the goals of an equitable 

transplant system are being achieved; 

that the Secretary has the authority to 

make those policies enforceable; and 

that patients and physicians have timely 

access to accurate data that will assist 

them in making decisions regarding 

intestinal transplantation. Upon 

consideration of the foregoing factors, 

and in order to achieve the most 

equitable and medically effective use of 

donated organs, the Secretary 

announces his conclusion that 

intestines should explicitly be added to 

the definition of organs covered by the 

final rule. 

Public Participation 

Additional information on the 

submission of comments and/or the 

rulemaking process can be obtained 

from the Director, Division of Policy 

Review and Coordination, Health 

Resources and Services Administration 

(HRSA), 5600 Fishers Lane, Room 14A–

11, Rockville, Maryland 20857. 

Soliciting Public Comment as to 

Whether Any Other Organs Should Be 

Covered by the Rules Governing the 

Operation of the OPTN 

The Secretary also invites public 

comment as to the advisability of 

including any other organ within the 

ambit of the final rule. In addition to 

intestines, there may be other organs not 

currently covered under the final rule 

that, as a result of factors such as 

medical advances, a growing demand 

for transplantation, and concerns about 

equitable allocation, should be 

considered for inclusion under the final 

rule. 

Including Intestines Within the 

Definition of Human Organs Covered by 

Section 301 of NOTA 

The Secretary further proposes 

including intestines within the 

definition of human organs covered by 

section 301, as amended, of the National 

Organ Transplant Act (NOTA) 

(hereinafter section 301), which 

prohibits the purchase or sale of human 

organs for human transplantation. 

Specifically, section 301, as amended, 

provides as follows: 

Prohibition of Organ Purchases 

(a) Prohibition 

It shall be unlawful for any person to 

knowingly acquire, receive, or otherwise 

transfer any human organ for valuable 

consideration for use in human 

transplantation if the transfer affects 

interstate commerce. 

(b) Penalties 

Any person who violates subsection 

(a) of this section shall be fined not 

more than $50,000 or imprisoned not 

more than five years, or both. 

(c) Definitions 

For purposes of subsection (a) of this 

section: 

(1) The term ‘‘human organ’’ means 

the human (including fetal) kidney, 

liver, heart, lung, pancreas, bone 

marrow, cornea, eye, bone, and skin or 

any subpart thereof and any other 

human organ (or any subpart thereof, 

including that derived from a fetus) 

specified by the Secretary of Health and 

Human Services by regulation. 

(2) The term ‘‘valuable consideration’’

does not include the reasonable 

payments associated with the removal, 

transportation, implantation, 

processing, preservation, quality 

control, and storage of a human organ or 

the expenses of travel, housing, and lost 

wages incurred by the donor of a human 

organ in connection with the donation 

of the organ. 

(3) The term ‘‘interstate commerce’’

has the meaning prescribed for it by 

section 321(b) of Title 21. 

42 U.S.C. 274e. When it originally 

enacted NOTA, Congress defined the 

term ‘‘human organ,’’ within the 

Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 70767 

meaning of this section as ‘‘the human 

kidney, liver, heart, lung, pancreas, 

bone marrow, cornea, eye, bone, and 

skin and any other human organ 

specified by the Secretary of Health and 

Human Services by regulation.’’ NOTA, 

Pub. L. 98–507, Title III, section 301, 98 

Stat. 2346–2347 (1984). This section 

was subsequently amended by Congress 

to include fetal organs, as well as 

subparts of the specified organs. Pub. L. 

100–607, Title IV, section 407, 102 Stat. 

3116 (1988). 

As set forth by statute, Congress 

authorized the Secretary to add 

additional organs to the definition of 

‘‘human organ’’ covered by section 301 

through rulemaking in order to include 

the transplantation of additional human 

organs within section 301’s prohibition. 

Through this notice, the Secretary 

proposes to add intestines to the list of 

human organs covered by section 301. 

The Secretary proposes adding a new 

section to part 121 to effectuate this 

addition, which section 301 authorizes 

the Secretary to make by rulemaking. 

Economic and Regulatory Impact 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when rulemaking is necessary, to select 

regulatory approaches that provide the 

greatest net benefits (including potential 

economic, environmental, public health, 

safety, distributive and equity effects). 

In addition, under the Regulatory 

Flexibility Act, if a rule has a significant 

economic effect on a substantial number 

of small entities the Secretary must 

specifically consider the economic 

effect of a rule on small entities and 

analyze regulatory options that could 

lessen the impact of the rule. 

Executive Order 12866 requires that 

all regulations reflect consideration of 

alternatives, of costs, of benefits, of 

incentives, of equity, and of available 

information. Regulations must meet 

certain standards, such as avoiding an 

unnecessary burden. Regulations which 

are ‘‘significant’’ because of cost, 

adverse effects on the economy, 

inconsistency with other agency actions, 

effects on the budget, or novel legal or 

policy issues, require special analysis. 

The Secretary has determined that no 

resources are required to implement the 

requirements in this rule. Therefore, in 

accordance with the Regulatory 

Flexibility Act of 1980 (RFA), and the 

Small Business Regulatory Enforcement 

Act of 1996, which amended the RFA, 

the Secretary certifies that this rule will 

not have a significant impact on a 

substantial number of small entities. 

Since independent and hospital-based 

organ procurement organizations 

(OPOs) are not considered small rural 

hospitals, because OPOs generally 

service large geographical areas, a 

regulatory flexibility analysis under the 

RFA and a rural impact analysis under 

section 1102(b) of the Act are not 

required. 

The Secretary has also determined 

that this proposed rule does not meet 

the criteria for a major rule as defined 

by Executive Order 12866 and would 

have no major effect on the economy or 

Federal expenditures. We have 

determined that the proposed rule is not 

a ‘‘major rule’’ within the meaning of 

the statute providing for Congressional 

Review of Agency Rulemaking, 5 U.S.C. 

801. Similarly, it will not have effects 

on State, local, and tribal governments 

and on the private sector such as to 

require consultation under the 

Unfunded Mandates Reform Act of 

1995. 

Nor on the basis of family well-being 

will the provisions of this rule affect the 

following family elements: Family 

safety, family stability, marital 

commitment; parental rights in the 

education, nurture and supervision of 

their children; family functioning, 

disposable income or poverty; or the 

behavior and personal responsibility of 

youth, as determined under section 

654(c) of the Treasury and General 

Government Appropriations Act of 

1999. 

As stated above, this proposed rule 

would modify the regulations governing 

the OPTN and section 301 of NOTA 

based on legal authority. 

Impact of the New Rule 

This proposed rule would have the 

effect of including transplanted human 

intestines within the ambit of the 

regulations governing the operation of 

the OPTN, and would include 

transplanted human intestines within 

the prohibition set forth at section 301 

of NOTA. If implemented, the proposals 

set forth in this rule would authorize the 

Secretary to take enforcement actions 

against entities violating OPTN policies 

pertaining to the transplantation of 

intestines once such policies are 

approved as enforceable by the 

Secretary. In addition, if this proposal is 

implemented, individuals violating 

section 301 of NOTA with respect to 

intestinal transplants would be subject 

to criminal penalties. 

Paperwork Reduction Act of 1995 

The amendments proposed in this 

notice of proposed rulemaking will not 

impose any additional data collection 

requirements beyond those already 

imposed under the current final rule, 

which have been approved by the Office 

of Management and Budget (OMB No. 

0915–0157). The currently approved 

data collection includes worksheets and 

burden for intestinal transplants. 

List of Subjects in 42 CFR Part 121 

Health care, Hospitals, Organ 

transplantation, Reporting and 

recordkeeping requirements. 

Dated: March 1, 2005. 

Elizabeth M. Duke, 

Administrator, Health Resources and Services 

Administration. 

Approved: May 20, 2005. 

Michael O. Leavitt, 

Secretary. 

Editorial Note: This document was 

received at the Office of the Federal Register 

November 18, 2005. 

Accordingly, 42 CFR part 121 is 

proposed to be amended as set forth 

below: 

PART 121—ORGAN PROCUREMENT 

AND TRANSPLANTATION NETWORK 

1. The authority citation for part 121 

is revised to read as follows: 

Authority: Sections 215, 371–376 of the 

Public Health Service Act (42 U.S.C. 216, 

273–274d); sections 1102, 1106, 1138 and 

1871 of the Social Security Act (42 U.S.C. 

1302, 1306, 1320b–8 and 1395hh); and 

section 301 of the National Organ Transplant 

Act, as amended (42 U.S.C. 274e). 

2. Amend § 121.1 as follows: 

a. Revise paragraph (a) by replacing 

the phrase ‘‘this part apply’’ with the 

phrase ‘‘this part, with the exception of 

§ 121.13, apply.’’

b. Redesignate paragraph (b) as 

paragraph (c). 

c. Add a new paragraph (b). 

The revision reads as follows: 

§ 121.1 Applicability. 

* * * * * 

(b) The provisions of § 121.13 apply to 

the prohibition set forth in section 301 

of the National Organ Transplant Act, as 

amended. 

* * * * * 

3. Revise the definition of ‘‘organ’’ in 

§ 121.2 to read as follows: 

§ 121.2 Definitions. 

* * * * * 

Organ means a human kidney, liver, 

heart, lung, pancreas, or intestine. 

* * * * * 

4. Add a new § 121.13 to read as 

follows: 

§ 121.13 Definition of Human Organ Under 

section 301 of the National Organ 

Transplant Act, as amended. 

‘‘Human organ,’’ as covered by section 

301 of the National Organ Transplant 

70768 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 

Act, as amended, means the human 

(including fetal) kidney, liver, heart, 

lung, pancreas, bone marrow, cornea, 

eye, bone, skin, and intestine (or any 

subpart thereof). 

[FR Doc. 05–23149 Filed 11–22–05; 8:45 am] 

BILLING CODE 4160–15–P 

NATIONAL FOUNDATION ON THE 

ARTS AND THE HUMANITIES 

45 CFR Part 1182 

RIN 3137–AA17 

Institute of Museum and Library 

Services; Implementation of the 

Privacy Act of 1974 

AGENCY: Institute of Museum and 

Library Services (IMLS), NFAH. 

ACTION: Proposed rule. 

SUMMARY: The Institute of Museum and 

Library Services (Institute) in publishing 

a proposed rule setting forth regulations 

under the Privacy Act of 1974 and 

conforming to the President’s 

memorandum of June 1, 1998—Plain 

Language in Government Writing. These 

regulations establish procedures by 

which an individual may determine 

whether a system of records maintained 

by the Institute contains a record 

pertaining to him or her; gain access to 

such records; and request correction or 

amendment of such records. These 

regulations also establish exemptions 

from certain Privacy Act requirements 

for all or part of certain systems or 

records maintained by the Institute. 

DATES: Comments are invited and must 

be received by no later than December 

23, 2005. 

ADDRESSES: Address all comments 

concerning this proposed rule to Nancy 

E. Weiss, General Counsel, Institute of 

Museum and Library Services, 1800 M 

Street, NW., 9th Floor, Washington, DC 

20036. Submit electronic comments to 

nweiss@imls.gov. Telephone: (202) 653–

4784. Facsimile: (202) 653–4625. 

FOR FURTHER INFORMATION CONTACT: 

Nancy E. Weiss, General Counsel, 

Institute of Museum and Library 

Services, 1800 M Street, NW., Ninth 

Floor, Washington, DC 20036. E-mail: 

nweiss@imls.gov. Telephone: (202) 653–

4787. Facsimile: (202) 653–4625. 

SUPPLEMENTARY INFORMATION: The 

Institute operates as part of the National 

Foundation on the Arts and the 

Humanities under the National 

Foundation on the Arts and the 

Humanities Act of 1965, as amended (20 

U.S.C. 951 et seq.). The corresponding 

regulations published at 45 CFR Chapter 

XI, Subchapter A apply to the entire 

Foundation, while the regulations 

published at 45 CFR Chapter XI, 

Subchapter E apply only to the Institute. 

This proposed rules adds Privacy Act 

regulations to Subchapter E (45 CFR 

part 1182), replacing the existing 

regulations in Subchapter A (45 CFR 

part 1115) with regard to the Institute. 

The new regulations provide additional 

detail concerning several provisions of 

the Privacy Act, and are intended to 

increase understanding of the Institute’s 

Privacy Act policies. The Institute is 

authorized to propose the new 

regulations under 5 U.S.C. 552a(f) of the 

Privacy Act. 

SUPPLEMENTARY INFORMATION: 

I. Public Comment Procedures 

The regulatory repeal proposed in this 

rulemaking eliminates outdated 

regulations and makes technical 

amendments to reflect Congress’

reauthorization of the Institute of 

Museum and Library Services under 

The Museum and Library Services Act 

of 2003, Public Law 108–81 (September 

25, 2003). These changes are proposed 

to ensure that all regulations governing 

provision of grants made by the Institute 

are consistent with current statutory 

guidance and agency practice. The 

public is invited to make substantive 

comment on any of these proposed 

changes. 

Comments should be submitted in 

writing to the address indicated in the 

ADDRESSES section of this document. All 

comments received will be available 

upon request for public inspection at 

Institute of Museum and Library 

Services, 1800 M Street, NW., Ninth 

Floor, Washington, DC 20036. All 

written comments received by the date 

indicated in the DATES section of this 

document and all other relevant 

information in the record will be 

carefully assessed and fully considered 

prior to publication of the final rule. 

Any information considered to be 

confidential must be so identified and 

submitted in writing. We will not 

consider comments submitted 

anonymously. However, if you wish us 

to withhold your name and/or address, 

you must state this prominently at the 

beginning of your comment. 

II. Matters of Regulatory Procedure 

Regulatory Planning and Review (E.O. 

12866) 

Under Executive Order 12866, the 

Institute must determine whether the 

regulatory action is ‘‘significant’’ and 

therefore subject to OMB review and the 

requirements of the Executive Order. 

The Order defines a ‘‘significant 

regulatory action’’ as one that is likely 

to result in a rule that may: (1) Have an 

annual effect on the economy of $100 

million or more or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

The Proposed rules would add 

Privacy Act regulations to subchapter E 

(45 CFR part 1182), replacing the 

existing regulations in Subchapter A (45 

CFR part 1115) with regard to the 

Institute. The new regulations provide 

additional detail concerning several 

provisions of the Privacy Act, and are 

intended to increase understanding of 

the Institute’s Privacy Act policies. As 

such, it does not impose a compliance 

burden on the economy generally or on 

any person or entity. Accordingly, this 

rule is not a ‘‘significant regulatory 

action’’ from an economic standpoint, 

and it does not otherwise create any 

inconsistencies or budgetary impacts to 

any other agency or Federal Program. 

Regulatory Flexibility Act 

Because this proposed rule would add 

Privacy Act regulations to Subchapter E 

(45 CFR part 1182), replacing the 

existing regulations in Subchapter A (45 

CFR part 1115) with regard to the 

Institute, the Institute has determined in 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) review that this proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Paperwork Reduction Act 

This rule is exempt from the 

requirements of the Paperwork 

Reduction Act, since it adds Privacy Act 

regulations to Subchapter E (45 CFR 

part 1182), replacing the existing 

regulations in Subchapter A (45 CFR 

part 1115) with regard to the Institute. 

An OMB form 83–1 is not required. 

Unfunded Mandates Reform Act 

For purposes of the Unfunded 

Mandates Reform Act of 1995 (2 U.S.C. 

chapter 25, subchapter II), this rule will 

not significantly or uniquely affect small 

governments and will not result in 

increased expenditures by State, local,