[The Regulatory Plan and Unified Agenda of Federal Regulations]
[Department of Health and Human Services Regulatory Plan]
[From the U.S. Government Printing Office, www.gpo.gov]


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Statement of Regulatory Priorities
Overall Regulatory Priorities
The Department of Health and Human Services (HHS) provides direct 
services or assistance to one of every five Americans. With emphasis on 
children, the elderly, disabled persons, the poor, and others who are 
most vulnerable, HHS is the Federal Government's principal agency for 
protecting health and providing essential human services to Americans. 
HHS activities are striking in their variety, ranging from some of the 
largest programs in Government (Medicare, Medicaid) to some of the 
smallest; from improving infant health to providing care for the 
elderly; from gathering basic national health and welfare statistics to 
providing job training, health clinics, and Head Start services; and 
from the cutting edge of health research at the National Institutes for 
Health to regulating products that account for some 25 cents of every 
dollar spent by American consumers at the Food and Drug Administration.
HHS is committed to the Administration's initiatives to substantially 
reform existing regulations in order to reduce regulatory burden while 
meeting the health and human services responsibilities of the 
Department.
HHS began its comprehensive review of existing regulations with 
implementation of the President's Executive Order 12866 of September 
30, 1993, on Regulatory Planning and Review. To assist in identifying 
priorities for HHS's review of existing regulations, the Department 
solicited recommendations from the public on plans for review in a 
January 20, 1994, Federal Register notice. More recently, on May 8, 
1995, HHS again requested public comment on this Department's 
regulations in the Unified Agenda, seeking suggestions for furthering 
regulatory reform efforts.
HHS's review accelerated in 1995 with the establishment of regulatory 
reinvention task forces targeted at specific industries, under the 
leadership of the Vice President. HHS played a major role in two of 
these groups--one on drugs and medical devices and one on the health 
care industry. These efforts produced important reforms in regulations 
concerning clinical laboratories, hospitals, dialysis centers, drugs, 
biologics, and medical devices.
The Regulatory Reinvention Initiative
With the President's March 4, 1995, memorandum on the ``Regulatory 
Reinvention Initiative,'' HHS joined the Governmentwide effort to 
pursue additional steps to reduce unnecessary regulatory burden and to 
increase cooperation and coordination with its customers. Specifically, 
the President asked that the Department:
 Conduct a page-by-page review of HHS regulations, with the 
            goal of eliminating or revising those that are outdated or 
            otherwise in need of reform;
 Change the way performance is measured by agencies and 
            frontline regulators to focus on results rather than on 
            process and punishment;
 Create ``grassroots partnerships'' by getting out of 
            Washington and convening groups of frontline regulators and 
            the people affected by regulations to discuss issues of 
            concern; and
 Increase use of consensual rulemaking.
These efforts have been a major undertaking of the Department. The 
changes in our regulations and rulemaking approach are reducing burden, 
as well as promoting better communication, consensus building, and a 
less adversarial environment while maintaining the critical health and 
safety protections the American people expect and deserve. As a result 
of this year's page-by-page review of HHS's portion of the Code of 
Federal Regulations (more than 6,900 pages), the Department plans to 
eliminate more than 1,000 pages by rulemaking (approximately 15%), as 
well as an additional 700 or so pages that will require statutory 
change, and reinvent another 2,200 pages (approximately 32%). In all, 
HHS plans to eliminate or reinvent over 50 percent of the pages.
These efforts have already produced a number of successes in reducing 
burden. For example, the Medicare program will no longer require the 
``attestation statements'' that physicians had to sign before hospitals 
could submit claims for payment. These statements were abolished in a 
final rule published September 1, 1995. Ending this requirement 
eliminates 11 million forms a year, saving almost 200,000 hours of 
physician time and decreasing hospital administrative costs by 
approximately $22,500 per hospital annually.
In another case, before a regulation was issued in July 1995 by the 
National Institute for Occupational Safety and Health (NIOSH), the only 
respirator for health care workers that met criteria for the prevention 
of tuberculosis cost the purchaser approximately $8. The first 
respirators certified under the new regulation range in price from 
about $1 to $3, according to manufacturers' data. Working closely with 
the industry, NIOSH developed a regulation that provides better 
protection for workers and increased savings for industry.
Other examples of reinvention of HHS regulations and approaches to 
rulemaking are discussed throughout this year's Regulatory Plan and 
Unified Agenda.
Consultation with our Partners
HHS has examined its approach to rulemaking in light of Executive Order 
12866, the Regulatory Reinvention Initiative, Executive Order 12875 on 
Intergovernmental Partnerships, and the related legislation on Unfunded 
Mandates. As a result, HHS is undertaking more frequent and earlier 
consultation with those parties affected by rulemaking. HHS will use a 
number of innovative approaches as it works on developing the most 
effective strategies for consultation with State and local governments 
and the wide variety of other groups and individuals affected by 
regulations issued by this Department. For example, in the spring of 
1995, senior HHS officials from the Food and Drug Administration, the 
Health Care Financing Administration, and the Administration for 
Children and Families held grassroots meetings at a number of locations 
around the Nation to hear first-hand the concerns of our regulatory 
partners regarding the issues facing the Department.
Last year for the first time, the Department used the negotiated 
rulemaking approach to develop rules in a consensual process. This 
process brings HHS together with the external interests who would be 
significantly affected by a new rule to reach consensus through open 
discussions on some or all issues under consideration before a rule is 
formally published as a notice of proposed rulemaking. HHS recently 
completed a negotiated rulemaking for reforming the Medicare hospice 
wage index and is now using the process to revamp the Indian health 
programs based on the Indian Self-Determination and Education 
Assistance Act.
HHS is taking a new approach to its relationship with State, local, and 
tribal governments. Pursuant to Executive Order 12875 ``Enhancing the 
Intergovernmental Partnership'' and the ``Unfunded Mandate Reform Act 
of 1995,'' HHS is committed to avoiding, where possible, imposition of 
mandates--funded, and particularly unfunded--and to consulting with 
appropriate levels of government as early as possible in the 
development of policies and regulations affecting them. HHS is carrying 
out its decisionmaking and consultation with a full appreciation of 
State, local, and tribal governments as partners in serving the public.
The Department's regulatory priorities also include initiatives related 
to implementation of the Department's strategic goals and enacted 
congressional legislation. For example, new Head Start regulations will 
not only strengthen the existing program as an investment in our 
Nation's children, but will also implement the new component for 
infants and toddlers through performance standards. Another regulatory 
initiative that will further the goal of investing in the future of our 
Nation's children is the Food and Drug Administration proposed rule 
restricting the sale and distribution of addictive tobacco products to 
children and adolescents.
Because of the significance of HHS's regulatory responsibilities, the 
Department believes that the principles of Executive Order 12866, the 
Regulatory Reinvention Initiative, and related efforts are particularly 
important in assuring that HHS's activities most effectively meet their 
objectives with as little burden as possible on the public. In ongoing 
efforts, HHS will emphasize regulating only where required by statute 
or to meet a compelling public need, fully considering the costs and 
benefits of regulatory alternatives, increasing consultation with 
affected public, and reducing regulatory burden.
Agency Plans
Virtually all HHS regulations are issued by a handful of agencies 
within the Department. Descriptions of priorities for these are as 
follows.
Health Care Financing Administration (HCFA)
HCFA has improved its regulations by focusing on rulemakings that 
reduce unnecessary burden, while ensuring continual improvement in the 
quality of services to Medicare and Medicaid beneficiaries. Working 
closely with the public in developing new rules, HCFA has been 
conducting listening events around the country concerning specific 
regulations to collect ideas on partnerships from front-line 
regulators, those being regulated, and other interested stakeholders. 
Some examples of specific successes follow.
Accomplishments
Even before the September 1, 1995, elimination of the physician 
attestation requirement mentioned above, HCFA eliminated the regulatory 
requirement that hospitals obtain a signed acknowledgement form from 
each attending physician every year. This form acknowledged that the 
physician understood the penalty for misrepresenting the information on 
an attestation statement relating to principal and secondary diagnoses 
and major procedures performed on patients. Beginning in April 1994, 
physicians are only required to sign a one-time acknowledgement 
statement upon being granted admitting privileges at a hospital.
As a result of a rule published July 25, 1994, the process for 
obtaining Medicaid home and community-based services waivers was 
simplified and now enables States to offer a wide variety of home and 
community-based services as cost-effective alternatives to more 
expensive institutional care. Without this regulatory change, joint 
State and Federal efforts to expand opportunities to provide cost-
effective alternatives to institutional care would have been 
frustrated. The regulatory provisions were worked out in collaboration 
with the States, through the National Governor's Association.
HCFA successfully completed negotiated rulemaking for the wage index 
that is used to adjust payment rates to hospices under the Medicare 
program. As part of the agreement with the members of the negotiating 
committee, the hospice wage index will rely on the most recent data 
from the hospital wage index published in the Medicare hospital 
prospective payment systems rule published on September 1, 1995.
HCFA and the Centers for Disease Control and Prevention (CDC), which 
share responsibility for the Clinical Laboratory Improvement Act (CLIA) 
program, have continually taken actions to reduce burden and improve 
the entire CLIA system. A flexible survey system for good performers, 
which has already been initiated for certain laboratories, allows for 
self-attestation and off-site reviews. Information requirements and 
paperwork have been eliminated, steps have been taken to make personnel 
requirements more flexible, and the inspection process has been 
streamlined. Additional burden reductions have been undertaken that 
will virtually eliminate oversight for certain appropriate 
laboratories, establish performance standards in place of process 
requirements, and use information and education as a substitute for 
sanctions.
As of September 1, 1995, six private accrediting organizations have 
been approved for Federal accrediting status (``deemed'' status) 
because their accreditation standards are as stringent as those of 
CLIA. In addition, exemption from CLIA requirements has been granted to 
laboratories in two States because the States in which they are located 
have requirements equal to or more stringent than CLIA's. The impact of 
these actions is to reduce Federal inspections, offer laboratories 
oversight by peers, and allow States with strong licensure programs to 
be approved for exemption from CLIA.
HCFA's Regulatory Reform Initiatives Included in the 1995 Plan
The October 1995 Plan includes the President's and Vice President's 
initiatives for reinventing health care regulations. (One of the 
initiatives, eliminating the physician attestation form, was finalized 
in the September 1, 1995, annual rule on the hospital prospective 
payment system and is not included in the 1995 Plan.)
CLIA regulations are being revised to reduce unnecessary burden and 
improve the CLIA system by rewarding good performance by laboratories, 
creating incentives for manufacturers to develop more reliable testing 
equipment, and using proficiency testing as an outcome measure to 
monitor laboratory performance.
New regulations for hospitals, home health agencies (HHAs), and end-
stage renal disease (ESRD) facilities will focus on the outcomes of 
care and replace unnecessary process requirements. These three proposed 
rules would provide for the collection and analysis of patient care 
data needed for continuous quality improvement and performance 
evaluation, increase consistency of requirements across providers, and 
ask the customer to provide input on what the outcome measures should 
be and evaluate the services they received.
HCFA will conduct a pilot project in four States to apply a different, 
less prescriptive set of rules to excellent ESRD facilities. Under the 
pilot project, an ESRD facility's performance will be measured using 
only three key patient care outcome indicators. Facilities that 
document sustained achievement in the outcome indicators over 6 
consecutive months will be awarded a HCFA certificate of excellence. 
Information about project results will be packaged in brochures and 
newsletters so that ESRD patients and nonparticipating ESRD facilities 
will be aware of the results.
HCFA will also conduct a pilot project that will evaluate the impact of 
the elimination of Medicare personnel requirements for ESRD facilities. 
The pilot project will be conducted in concert with the project 
establishing relaxed rules for ESRD facilities with good track records 
(see above). HCFA will collect information regarding the skills level 
of all personnel employed by those facilities participating in the 
project. Facilities will be informed that as part of the project 
Medicare will not apply any of the personnel requirements contained in 
the conditions for coverage. At the end of the 2-year project period, 
HCFA will re-collect information regarding the education and experience 
levels of all the facility's staff and evaluate the impact of the 
changes on predetermined measures of quality of care.
HCFA's Legislative Initiatives
Three of the initiatives from the July 1995 report will require 
statutory revisions before new regulations can be developed. First, 
Home Health Agencies are required by law to be surveyed yearly, even 
though historical data show that this frequency is excessive for many 
HHAs and does not improve care. Legislation is being proposed to allow 
flexible survey cycles.
Second, States must currently perform annual assessments of Medicaid 
nursing home residents with mental illness or mental retardation. This 
duplicates the requirement for Medicare- and Medicaid-certified nursing 
homes to assess their residents promptly after admission, after a 
significant change in condition, and no less often than annually. Under 
a legislative proposal, the redundant requirement for annual State 
reviews would be eliminated, reducing costly duplication. The 
assessments conducted by the nursing homes ensure that residents' 
continuing needs are properly evaluated and met.
Third, a legislative proposal would specify that a State could choose 
to approve a nurse aide training and competency evaluation program 
offered in (but not by) a nursing home, subject to an extended or 
partial extended survey or certain other sanctions, if the State 
determines that there is no other nurse aide training and competency 
evaluation program offered within a reasonable distance. This statutory 
change would relieve a special problem encountered by rural nursing 
homes where alternate training programs may not be readily accessible. 
The proposal would alleviate this problem and still ensure patient 
health and safety.
HCFA's Objectives
HCFA has made communication, cooperation, and partnership the guiding 
principles of the regulatory process, replacing the adversarial 
environment that often existed in the past. At a time when the American 
health care system is undergoing dramatic changes, HCFA is committed to 
putting the Federal Government's customers--the American people--first. 
The Nation can look forward to continued endeavors to reduce and 
eliminate unnecessarily burdensome regulations.
Food and Drug Administration (FDA)
FDA has made substantial progress toward carrying out vitally important 
regulatory reforms identified in response to the Clinton 
Administration's emphasis on reforming the Federal Government's 
regulatory processes with no sacrifice in public health and safety 
protections. FDA's reforms have three broad goals: to eliminate 
unnecessary burdens on the regulated industry, to get products to 
market more quickly, and to allow FDA to do its job more efficiently. 
The agency is well on its way toward accomplishing many of these 
reforms--others are in early stages of development, and still more 
potential reforms have been identified. For example, FDA has already 
outlined, in a report published by the Clinton Administration in April, 
a number of reforms that are under way in the regulation of drugs, 
biologics--including biotechnology products--and medical devices. The 
agency will propose further reforms in these areas and has identified 
and will propose reforms for human food products, new animal drugs, and 
medicated animal feeds.
Under the Prescription Drug User Fee Act of 1992, FDA has used the 
income from user fees to shorten substantially the review of new drugs, 
vaccines, and biotechnology products. Average review times dropped by 
more than 30 percent between 1992 and 1994--from 30 months to 20 
months, and by 1997 FDA will be making decisions on these products in a 
year or less after applications are submitted--as fast, or faster than 
anywhere else in the world, with no sacrifice in quality. Medical 
devices and animal drugs are now reviewed more efficiently as well, and 
a record number of 38 new animal drugs was approved in 1994.
Regulatory Reinvention Proposals
The reforms identified so far for drugs, biologics, and medical devices 
are estimated to save manufacturers $500 million per year through 
measures such as:
 Allowing manufacturers of drugs and biologics to change the 
            way they manufacture an approved product without submitting 
            applications for FDA preapproval if the risk involved is 
            negligible;
 Publishing a notice on April 6, 1995, clarifying that biologic 
            manufacturers may use pilot or small-scale facilities 
            (instead of building far more costly full-scale facilities) 
            to conduct safety and efficacy studies of their products;
 Eliminating special requirements for insulin and antibiotics 
            that are outdated and burdensome to manufacturers of these 
            products;
 Excluding drug and biologic manufacturers from requirements 
            for most environmental assessments, which cost tens of 
            thousands of dollars and provide no real benefit to the 
            environment;
 Exempting up to 125 categories of low-risk medical devices 
            from premarket review, adding to the 441 categories already 
            exempted from review (a final rule exempting 9 categories 
            was published on July 28, along with a proposal to exempt 
            12 additional categories);
 Publishing a notice on June 2, 1995, eliminating the 
            ``Reference List'' program by clarifying that marketing 
            clearance of a device will not be deferred for uncorrected 
            manufacturing violations unless there is a reasonable 
            relationship between the violations and the application 
            under review;
 Seeking authority to set up a user-fee program for medical 
            devices, similar to the program that has shortened drug 
            reviews, that would allow FDA to charge industry user fees 
            and commit the agency to meet strict performance goals;
 Publishing a notice on August 1, 1995, clarifying FDA's 
            effectiveness requirement for drugs and medical devices, to 
            give industry a better understanding of how to go about 
            developing new products and firmly refute a concern that 
            FDA requires a new drug or device to be more effective than 
            comparable therapies that are already approved; and
 Harmonizing FDA's drug and device testing requirements with 
            those of other countries, to reduce duplicative testing and 
            expedite international marketing of new products.
Some of the reforms in the April report are facilitated by regulations 
included in the Unified Agenda, which appears elsewhere in this issue 
of the Federal Register. For example, for documents required to be 
maintained but not submitted to FDA, persons could use electronic 
records and signatures upon the effective date of a final rule. For 
documents submitted to FDA, persons could use electronic records and 
signatures if FDA has stated, in a public docket to be maintained for 
that purpose, that the intended receiving organization is prepared to 
accept the submission in electronic form. This step will simplify 
recordkeeping for industry and will support FDA's Submission Management 
and Review Tracking (SMART) Program, which aims to develop and 
implement a number of automated applications, including Establishment 
Licensing Applications for biologics firms, a gene therapy patient 
registry, and preapproval inspections.
In other Unified Agenda entries, FDA is proposing to expand the 
criteria for allowing the export of investigational medical devices to 
developed countries. The goals of this reform are to relax restrictions 
on exports of investigational products to industrialized nations, while 
leaving intact existing protections for countries that are not 
industrialized. FDA is also proposing to allow the name of the 
developer of a biologic (which must be listed as a selling agent or 
distributor) to be listed in product labeling with equal prominence as 
the name of the manufacturer. This will benefit small, innovative firms 
that develop important new therapies, but, because of a lack of 
capital, must rely on other firms to manufacture their therapies in 
commercial quantities.
Regulatory Plan Entries
FDA's Regulations Plan, which follows, contains initiatives that 
reflect the Clinton Administration's goal of providing traditional 
public health protections through a streamlined regulatory process that 
is focused on minimizing burdens on those who are regulated. 
Regulations included in the plan cut back significantly on the number 
of applications that drug and device manufacturers are required to 
submit, eliminate many pages of regulations that are outdated, 
duplicative, or otherwise in need of reform from the Code of Federal 
Regulations (CFR), seek to prevent children and adolescents from 
forming a habit with long-term health consequences, protect the health 
of women by assuring the high quality of mammography, and set forth a 
voluntary program of disseminating to consumers important information 
on their prescription drugs.
Currently, sponsors of licensed biological products must obtain FDA 
approval of such changes as changes in product labeling, production 
process, equipment, and facilities by submitting supplements to 
approved marketing applications. This process has become burdensome, 
time-consuming, and unnecessarily rigid, and FDA is proposing a new 
process that will reduce the number of supplements that license holders 
must submit for these changes each year by an estimated 50 percent--
from 1,000 to 500. The new process creates different categories for 
changes, based on their potential to adversely affect the product, and 
reporting requirements are tailored to each category.
FDA regulates 1,700 types of medical devices, and manufacturers of most 
of these types of devices must submit information to FDA and receive 
FDA clearance before marketing them. FDA has determined that, when such 
a device poses a low level of risk to patients, review is not necessary 
to protect the public health; it places an unnecessary regulatory 
burden on device manufacturers, and it delays introduction of new 
devices. Accordingly, FDA is proceeding to exempt low-risk medical 
devices from premarket notification requirements and, to date, has 
exempted 450 of them. The agency will issue a final rule exempting more 
than 100 additional types of devices so that, when this rulemaking is 
completed, one-third of the regulated devices will be exempted from 
premarket notification requirements.
In response to the President's charge to conduct a page-by-page review 
to identify regulations that are obsolete or otherwise in need of 
reform, FDA has determined that 941 pages of its regulations in the CFR 
should be deleted. Congressional approval will be sought for deletion 
of 735 of these pages, and FDA will propose to delete regulations that 
can be deleted administratively, including regulations that are 
actually statements of policy or guidance, that have been made 
inaccurate by changes in legislation or technology, or that are 
duplicative. FDA is proposing to delete a number of food standards for 
which there is little public interest, and regulations dealing with 
substances no longer used in product formulations or products that are 
no longer marketed.
If children and adolescents are prevented from using nicotine-
containing tobacco products habitually, they will avoid the serious 
health problems caused later in life by use and addiction to the 
nicotine in these products. FDA is proposing regulations that would 
affect the easy access and promotion and sale of nicotine-containing 
tobacco products to individuals at the young age when the majority of 
tobacco users take up the habit. The proposed rule would not restrict 
the use of tobacco products by adults.
Nearly half a million women will die of breast cancer during the 
nineties, and more than one and one-half million new cases will be 
diagnosed. Currently, the most effective method for detecting breast 
cancer is mammography. To assure quality in all aspects of mammography, 
FDA is proposing regulations to implement provisions of the Mammography 
Quality Standards Act (MQSA) that allow for oversight of all 
mammography facilities through a certification and inspection program. 
The proposed regulations set forth requirements for accreditation 
bodies, equipment, quality assurance, and personnel. The certification 
standards are existing private sector standards and allow 
implementation of the MQSA with minimum burden on mammography 
facilities.
In recognition of the importance of the individual participating in his 
or her own health care, FDA is proposing performance standards for drug 
labeling that will provide a readily available and understandable 
source of the information patients need in order to use their 
prescription drugs safely and properly. In accordance with the 
Administration's philosophy of fairly assessing a voluntary approach 
before imposing requirements through regulations, FDA is proposing that 
this information be disseminated through voluntary private sector 
initiatives. The goal of the proposal is for distribution of useful 
patient information to 75 percent of individuals receiving new 
prescriptions by the year 2000, and to 95 percent by the year 2006. 
Informing patients will reduce the potential for harm related to 
inappropriate prescription drug use and make it possible to realize 
substantial savings in health care costs.
Administration for Children and Families (ACF)
ACF is committed to a management and stewardship philosophy that 
fosters excellence through customer focus, results orientation, and the 
talents of staff. The agency has reinvented the way it conducts 
business: Redefining relationships with States, tribes, and other 
grantees; stressing creation of partnerships; and focusing on program 
outcomes that indicate improvement in the lives of children and 
families through efficient and effective means.
Regulatory reform is an important element of ACF's reinvention 
strategy. The agency has already undertaken a comprehensive, page-by-
page review of its regulations and eliminated hundreds of unnecessary 
pages. More importantly, a cultural change in the agency has taken 
place that will improve the approach taken in future rulemakings. All 
ACF regulatory efforts will, without fail, respond to the needs of 
State and local partners and the public at large by routinely employing 
a consultative process that is open and reaches out to all involved 
parties. In tandem with this, ACF is actively seeking to reduce burden 
and focus on outcome rather than process.
The benefits of this strategy will be evident in a key upcoming 
initiative to establish performance standards with respect to Head 
Start services provided to children 0 to 5 years old, as well as in the 
adoption of final rules proposed in the last regulatory planning 
period, including a computer systems rule designed to reduce reporting 
and recordkeeping burdens on States and Family Preservation and Family 
Support rules that provide a consultative and coordinated approach to 
service planning, consolidating two service programs under title IV-B 
of the Social Security Act. ACF will continue to create partnerships 
with the stakeholders of all new regulatory initiatives to effect 
improved services and outcomes for children and families.
_______________________________________________________________________
HHS--Substance Abuse and Mental Health Services Administration (SAMHSA)

                              -----------

                            FINAL RULE STAGE

                              -----------

26. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE 
(TOBACCO PROVISIONS)
Priority:


Other Significant


Legal Authority:


 42 USC 300x-21


CFR Citation:


 45 CFR 96; 45 CFR 130


Legal Deadline:


None


Abstract:


Sets procedures for the Secretary to determine compliance under section 
1926 of the PHS Act regarding State enforcement of laws against sale of 
tobacco products to minors as a condition of full funding of Federal 
block grants for prevention and treatment of substance abuse.


Statement of Need:


Section 1932(d) of the Public Health Service (PHS) Act requires the 
Secretary to publish regulations on the standards that will be used in 
approving Substance Abuse Prevention and Treatment Block Grant 
applications. Section 1926 of the PHS Act requires that States, as a 
condition of receiving a grant, must have in place a law that prohibits 
the sale and distribution of tobacco products to minors. It further 
requires the States to enforce the provision in a manner that can 
reasonably be expected to reduce the availability of tobacco products 
to minors, and to conduct annual, random, unannounced inspections to 
ensure compliance with the law.
In addition States are required to report as part of their application 
for Block Grant funds the activities carried out in the previous year 
for enforcing the provision, the State's success in reducing the 
availability of tobacco products to minors, and the activities it plans 
to carry out during the year for which it is seeking funds. If the 
Secretary determines that a State has not complied with the 
requirements of section 1926, the Secretary shall penalize the State 10 
percent of its allotment the first year, 20 percent the second, 30 
percent the third, and 40 percent the fourth and all subsequent years.
These regulations set the criteria and standards for the Secretary's 
determination of compliance with section 1926.
A notice of proposed rulemaking was issued on August 26, l993 and the 
public was given 60 days to comment. The Department will respond to 
those comments and amend the proposed rule as appropriate.


Alternatives:


The Department has minimal discretion in establishing the criteria and 
standards to use for establishing compliance. States are statutorily 
required to carry out random inspections of outlets in a manner that 
provides an accurate, reliable and valid measure of how successful the 
enforcement of the provisions is being conducted throughout the State. 
The results of these inspections constitute an objective measure for 
the Secretary's use in determining compliance.


Anticipated Costs and Benefits:


The NPRM was considered a major rule for the purposes of carrying out 
an economic impact analysis. With regard to the States enforcing the 
State laws on the availability of tobacco products to minors and for 
conducting the inspections, States may only use the 5 percent of their 
allocation that they currently use for the purposes of administering 
the block grant. Thus little or no Federal funds are available to the 
States to enforce their statute.
We estimate the cost of a substantial enforcement effort at $50 million 
nationwide. The costs of training staff, moving vending machines, etc., 
we estimate will cost businesses about $100 million nationwide. The 
costs of carrying out the inspections we believe will be between $1 and 
$2 million nationwide. This suggests a total cost of a maximum effort 
at $152 million nationwide.
The annual benefit of the provision is in reduction of medical bills 
incurred by those who choose to stop smoking; reduced sick leave and 
group life-insurance subsidies, increased productivity and the taxes 
realized from people choosing to stop smoking; the value of lives 
gained; reduced costs for fire damage that would have been caused by 
the smokers; and the lives saved from those fires that would not 
happen. We estimate these savings at one-sixth to one-third of a 
billion dollars per year.


Risks:


Implementation of the above-cited statute leaves the Department no 
option other than issuing a regulation in this area. In any case, the 
risks in not acting against illegal sales of tobacco products are 
great. The Centers for Disease Control and Prevention (CDC) estimate 
that at present approximately 500,000 minors become regular smokers 
each year. A major cause is ready access to illegal tobacco. Three 
fourths or more of all outlets sell illegally to minors, due in part to 
insufficient enforcement efforts by many States, which encourage a 
scofflaw attitude among merchants. CDC estimates that 73 percent of all 
over-the-counter outlets and 96 percent of all vending machine outlets 
sell tobacco products to minors.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            58 FR 45156                                    08/26/93
NPRM Comment Per58 FR 45156                                    10/25/93
Final Action                                                   12/00/95
Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


State, Tribal


Additional Information:


Previously reported under RIN 0905-AE05.
Alternate Contact: Sue Martone, DLEA, SAMHSA, PHS, Room 12C-15, 5600 
Fishers Lane, Rockville, MD 20852; 301-443-4640


Agency Contact:
Joseph D. Faha
Director, DLEA, SAMHSA
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane
12C-15
Rockville, MD 20857
Phone: 301 443-4640
RIN: 0930-AA03
_______________________________________________________________________
HHS--Food and Drug Administration (FDA)

                              -----------

                             PRERULE STAGE

                              -----------

27.  FOOD STANDARDS OF IDENTITY, QUALITY, AND FILL OF 
CONTAINER; COMMON OR USUAL NAME REGULATIONS: REQUEST FOR COMMENTS ON 
EXISTING REGULATIONS
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 348; 21 USC 
349; 21 USC 371; 21 USC 376


CFR Citation:


 21 CFR 102 to 103; 21 CFR 130 to 131; 21 CFR 133; 21 CFR 135 to 137; 
21 CFR 139; 21 CFR 145 to 146; 21 CFR 150; 21 CFR 152; 21 CFR 155 to 
156; 21 CFR 158; 21 CFR 160 to 161; 21 CFR 163 to 166; 21 CFR 168 to 
169


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is considering amending, 
revising, or revoking its food standards of identity, quality, and fill 
of container and its common or usual name regulations for 
nonstandardized foods to make them less burdensome on industry. A 
notice of proposed rulemaking that published October 13, 1995, 
identified, among other obsolete or otherwise unnecessary regulations, 
17 specific CFR sections on food standards for possible revocation. In 
addition an advance notice of proposed rulemaking (ANPRM) would request 
comments on other such standards from all interested parties, including 
consumers, consumer groups, academia, the regulated food industry, food 
distributors, importers, and exporters on these regulations. The agency 
would seek comments on the benefits or lack of benefits of such 
regulations in facilitating domestic, as well as international, 
commerce and on their value to consumers, less costly alternative means 
of accomplishing the statutory objective of food standards, that is, to 
promote honesty and fair dealing in the interest of consumers, in the 
manufacture and sale of food products covered by these regulations.


Statement of Need:


Standards of identity, quality, and fill of container are designed to 
protect consumers from manufacturing, packaging, and labeling practices 
that could result in economic deception, such as substitution of water 
or filler for more valuable constituents in a food or the use of 
substandard ingredients. Common or usual names are designed to ensure 
that the food products will bear names that are appropriately 
descriptive of the food so that consumers will be provided with 
sufficient information to make informed purchasing decisions in the 
marketplace. The agency has received complaints that some of these 
regulations should be amended, particularly some food standards, 
because they are overly restrictive and inhibit product development. 
Others may be obsolete and should be revised or revoked.


Summary of the Legal Basis:


Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) 
provides that food standards of identity, quality, and fill of 
container may be established when such action will promote honesty and 
fair dealing in the interest of consumers. Section 403(i) of the act 
which requires, among other things, that a nonstandardized food bear on 
its label the common or usual name of the food, and if the food is 
fabricated of two or more ingredients, the common or usual name of each 
such ingredient; and section 201(n) that provides, among other things, 
that an article (food, drug, or cosmetic) is alleged to be misbranded 
if its labeling or advertising fails to reveal material facts about the 
nature of the article, provide the agency with authority to establish 
common or usual name regulations. These regulations are promulgated 
under section 701(a) of the act (notice and comment rulemaking), except 
that actions for amendments or repeal of any dairy standards that are 
accomplished under section 701(e) of the act (formal rulemaking).


Alternatives:


This ANPRM requests public comment on ways to make existing regulations 
more flexible and less burdensome on industry. It also requests comment 
on alternatives to these regulations that will provide comparable 
consumer protection.


Anticipated Costs and Benefits:


A proper assessment of the costs and benefits to be derived from this 
ANPRM is premature.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          11/00/95
ANPRM Comment Period End                                       03/00/96
NPRM                                                           00/00/00
Final Action                                                   00/00/00
Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


State, Federal


Agency Contact:
Nannie H. Rainey
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
(HFS-158), 200 C St. SW., Washington
DC 20204
Phone: 202 205-5099
RIN: 0910-AA67
_______________________________________________________________________
HHS--FDA

                              -----------

                          PROPOSED RULE STAGE

                              -----------

28. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992
Priority:


Other Significant


Legal Authority:


 PL 102-539 Mammography Quality Standards Act of 1992; 42 USC 263b


CFR Citation:


 21 CFR 900


Legal Deadline:


 Final, Statutory, July 27, 1993.


Standards for accreditation bodies are required by July 27, 1993.


Abstract:


The purpose of the Mammography Quality Standards Act of 1992 (MQSA), 
enacted October 27, 1992, is to assure quality in all aspects of the 
practice of mammography. The primary mechanism for this is oversight of 
all mammography facilities through a certification and inspection 
program. Only facilities certified by the Secretary are permitted to 
produce, process, or interpret mammographic images. The statute also 
required the establishment of an advisory committee to set regulatory 
quality standards and also provided for the establishment of 
surveillance systems to evaluate breast cancer screening programs.
The agency published interim regulations on December 21, 1993, which 
were drafted and implemented so as to maximize lawful operation by 
facilities under existing quality standards, and to ensure adequate 
examinee access to quality mammography during the transition to more 
comprehensive national standards.
Concurrent with the implementation of the interim rules, FDA has 
proceeded with the development of proposed regulations to replace the 
interim rules. The agency now plans to issue proposed rules, with the 
advice and consultation of the National Mammography Quality Assurance 
Advisory Committee, on requirements for accreditation bodies, equipment 
and quality assurance requirements, facility requirements, and 
personnel requirements.


Statement of Need:


Nearly 50,000 women die each year from breast cancer. While much 
research into causes and treatments still needs to be done, we do know 
that, for women over 50, mortality for lesions found by mammography is 
30 percent less than for larger lesions identified by physical 
examination. Unfortunately, not all mammography facilities offer 
services commensurate with the value of mammography in the abstract. To 
ensure quality control compliance, the Congress enacted the MQSA.
The primary mechanism established by the MQSA to ensure quality in 
mammography is oversight of all mammography facilities through a 
certification and inspection program. Only facilities certified by the 
Secretary will be permitted to produce, process, or interpret 
mammographic images. The statute also requires the establishment of an 
advisory committee to set regulatory quality standards and also 
provides for the establishment of surveillance systems to evaluate 
breast cancer screening programs.
The implementation of these regulations will ensure that mammograms are 
properly administered and interpreted, to provide adequate protection, 
diagnosis, and treatment of breast cancer among women. FDA has worked 
with the Health Care Financing Administration, the Centers for Disease 
Control, and State and local radiation control officials to coordinate 
mammography quality assurance activities and the development of 
policies and regulations for implementation of the MQSA, and will 
continue to coordinate its efforts with these agencies as appropriate.


Summary of the Legal Basis:


The MQSA established a comprehensive statutory scheme for the 
certification and inspection of mammography facilities to ensure that, 
after October 1, 1994, only those facilities that comply with minimum 
Federal standards for safe, high-quality mammography services may 
lawfully continue to operate. Operation after that date is contingent 
on receipt of an FDA certificate attesting that the facility meets the 
minimum mammography quality standards promulgated under section 354(f) 
of the Public Health Service Act. The standards are intended to apply 
equally to screening and diagnostic mammography. The MQSA required: (a) 
accreditation of mammography facilities by private, nonprofit 
organizations or State agencies meeting FDA established standards; (b) 
annual physics surveys of mammography facilities; (c) annual 
inspections of mammography facilities; (d) qualification standards for 
interpreting physicians, radiologic technologists, medical physicists, 
and mammography facility inspectors; (e) specification by FDA of boards 
or organizations eligible to certify mammography personnel; (f) quality 
standards for mammography equipment and practices, including quality 
assurance; (g) establishment of the National Mammography Quality 
Assurance Advisory Committee; and (h) standards governing recordkeeping 
for examinee files and requirements for mammography reporting and 
examinee notification by physicians.


Alternatives:


The statute is prescriptive and does not allow for a substantially 
different regulatory approach than is being taken by FDA. It allows for 
discretion in the details of individual standards, and FDA has sought 
to avoid unnecessary burden in devising these standards. In order to 
reduce the burden of complying with the MQSA regulations on mammography 
facilities, FDA incorporated existing standards to the maximum extent 
possible; issued Federal certificates, which are required for 
facilities to legally operate after October 1, 1994, to facilities 
already accredited by the American College of Radiology; required 
facilities to submit information for certification only to the 
accrediting body--not to FDA; and allowed flexibility to accrediting 
bodies in developing their standards by requiring that accrediting body 
standards be ``substantially the same as'' FDA's standards, rather than 
identical.


Anticipated Costs and Benefits:


Direct Federal costs in fiscal year 1995 are $13 million. Yearly costs 
to mammography facilities, over a 10-year period, were estimated to 
range from a high of approximately $88.8 million to $24.3 million. 
Yearly costs differed due to the phased implementation dates for some 
proposed requirements. Overall, average annualized costs of the 
proposals are preliminarily estimated at $50.5 million.
There are many benefits associated with these proposed rules. High-
quality mammography could significantly reduce breast cancer mortality. 
Early detection could reduce the morbidity associated with treating 
later-stage disease. There may be a reduction in the number of 
malpractice claims filed for failure to diagnose early breast cancer. 
In addition, because of improved mammography quality, the agency 
expects a reduction in the number of follow-up procedures in 
nondiseased patients, resulting in a reduction of annual medical costs. 
By themselves, the health care cost savings are expected to 
substantially exceed the expected average annualized costs.


Risks:


The motivation for the MQSA was public response to concerns about 
breast cancer and to concerns about the quality of mammography services 
relied on for early detection of breast cancer. Breast cancer is the 
most prevalent nonskin cancer among women (and the second most deadly) 
with over 175,000 new cases and 45,000 breast cancer-related deaths 
occurring annually. The disease is most treatable in the early stages. 
Missed diagnosis of early lesions due to factors such as poor image 
quality or incorrect interpretation of images could result in delayed 
treatment, leading to otherwise avoidable increases in mortality or 
more complex and costly remediations.


Timetable:
_______________________________________________________________________
Approval of Accrediting Bodies
Interim Final Rule 12/21/93 (58 FR 67558)
Draft Proposed Quality Standards
Notice of Availability 01/26/95 (60 FR 5152)
Draft X-Ray and Medical Physicist Standards Proposals
Notice of Availability; 12/30/94 (59 FR 67710)
General Facility Requirements
NPRM 11/00/95
Mammography Quality Standards Act of 1992; Inspection Fees
Notice 03/17/95 (60 FR 4584)
Personnel Requirements
NPRM 11/00/95
Quality Standards for Mammography Equipment and QA
NPRM 11/00/95
Quality Standards for Mammography Facilities
Interim Final Rule 12/21/93 (58 FR 67565)
Requirements for Accreditation Bodies and Quality Standards
Notice (Advisory Committee) 12/21/94 (59 FR 65776)
NPRM 11/00/95
Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


State, Federal


Additional Information:


Previously reported under RIN 0905-AE07.


Agency Contact:
Richard E. Gross
Office of Health and Industry Programs
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health (HFZ-200), 1350 Piccard 
Drive Rockville, MD 20850
Phone: 301 443-2845
RIN: 0910-AA24
_______________________________________________________________________
HHS--FDA
29.  REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF 
CIGARETTES AND SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN AND 
ADOLESCENTS
Priority:


Economically Significant


Legal Authority:


 21 USC 351; 21 USC 360; 21 USC 360j; 21 USC 371; 21 USC 374


CFR Citation:


 21 CFR 801; 21 CFR 803; 21 CFR 804; 21 CFR 897


Legal Deadline:


None


Abstract:


The Food and Drug Administration is proposing new regulations governing 
the sale and distribution of nicotine-containing cigarettes and 
smokeless tobacco products to children and adolescents, in order to 
address the serious public health problems caused by the use of and 
addiction to these products. The proposed rule would reduce children's 
and adolescents' easy access to cigarettes and smokeless tobacco and 
would significantly decrease the amount of positive imagery that makes 
these products so appealing to them. The proposed rule would not 
restrict the use of tobacco products by adults.
The objective of the proposed rule is to meet the goal of the report 
``Healthy People 2000'' by reducing roughly by half children's and 
adolescents' use of tobacco products. If this objective is not met 
within 7 years of the date of publication of the final rule, the agency 
will take additional measures to help achieve the reduction in the use 
of tobacco products by young people. In the proposed rule, the agency 
is requesting comment regarding the type of additional measures that 
would be most effective.


Statement of Need:


Approximately 50 million Americans currently smoke cigarettes and 
another 6 million use smokeless tobacco products. These tobacco 
products are responsible for more than 400,000 deaths each year due to 
cancer, respiratory illnesses, heart disease, and other health 
problems. On average, smokers who die from a disease caused by smoking 
have lost 12 to 15 years of life because of tobacco use.


Summary of the Legal Basis:


The FDA has conducted an extensive investigation and has engaged in 
comprehensive legal analysis regarding the agency's jurisdiction over 
nicotine-containing cigarettes and smokeless tobacco products. The 
results of that inquiry and analysis support a finding at this time 
that nicotine in cigarettes and smokeless tobacco products is a drug, 
and that these products are drug delivery devices within the meaning to 
the Food, Drug, and Cosmetic Act. Traditionally, the FDA has initiated 
enforcement actions in cases where the agency determines that a product 
is a drug or a delivery device. Because the agency has elected to 
embark on this initiative through rulemaking, no enforcement action 
will be brought pending completion of that process.


Alternatives:


FDA is proposing to regulate cigarettes and smokeless tobacco products 
by employing its restricted device authority, which affords the most 
appropriate and flexible mechanism for regulating the sale, 
distribution, and use of these products. Rather than banning tobacco 
products for the millions of Americans who are currently addicted to 
them, this regulation focuses on preventing future generations from 
developing an addiction to nicotine-containing tobacco products.
One alternative considered by the agency was a far more prescriptive 
monitoring requirement for tobacco manufacturers. Under the 
alternative, each manufacturer of tobacco products would have been 
required to adopt a system for monitoring the sales and distributions 
of retail establishments. The additional cost for this monitoring was 
estimated at about $85 million per year. FDA rejected this alternative, 
because it was decided that the industry might employ its resources 
more efficiently if permitted to choose among alternative compliance 
modes. It is possible, however, that the industry might implement 
certain features of this approach in order to avoid the optional 
performance-based provision that would become effective if the 
``Healthy People 2000'' goals were not met.
A second alternative considered by the agency was to require package 
inserts containing educational information in cigarette and smokeless 
tobacco products. A preliminary projection of one-time costs of this 
rule were about $490 million and annual operating costs of about $54 
million. FDA did not select this alternative as the agency was not 
certain that the benefits of this provision would justify the large 
compliance costs.
FDA also considered setting the permissible age for purchase at 19 
rather than 18, because many 18-year-old adolescents are still in high 
school, where they can easily purchase tobacco products for classmates. 
This alternative would have added costs of about $34 million annually, 
mostly due to lost producer profits. The proposed regulation restricts 
access to regulated tobacco products for persons under the age of 18, 
because most adult smokers have already become regular smokers by the 
age 18, and because that age limit is already consistent with most 
State and local laws.
The agency also considered restricting rather than prohibiting sales 
from vending machines. However, studies indicated that measures such as 
placing locks on vending machines or restricting their placement failed 
to prevent young people from purchasing cigarettes from vending 
machines.


Anticipated Costs and Benefits:


To comply with the initial requirements of the rule, FDA projects that 
manufacturers and retailers of tobacco products would incur one-time 
costs ranging from $26 to $39 million and annual operating costs of 
about $227 million. Achieving the ``Healthy People 2000'' goals, 
however could demand still further efforts by tobacco manufacturers to 
restrict youth access to tobacco products. Moreover, FDA plans to 
propose additional requirements that would become effective only if 
these goals were not met.
Each year, an estimated 1 million adolescents begin to smoke 
cigarettes. It is estimated that at least 24% of these youngsters will 
ultimately die from causes related to their nicotine habit. Other 
studies suggest even higher rates of excess mortality. As a result, FDA 
projects that the achievement of the ``Healthy People 2000'' goals 
would prevent well over 60,000 early deaths, gaining over 900,000 
future life-years for each year's cohort of teenagers who would 
otherwise begin to smoke. The estimated monetary value of these 
benefits is projected to total from about $28 to $43 billion per year. 
In addition, the proposed rule would prevent numerous serious illnesses 
associated with the use of smokeless tobacco products.


Risks:


Cigarettes kill more Americans each year than acquired immune 
deficiency syndrome (AIDS), alcohol, car accidents, murders, suicides, 
illegal drugs, and fires combined. If even only a small fraction of the 
goals of the ``Healthy People 2000'' report were achieved, the benefits 
would be substantial. For example, it is estimated that halting the 
onset of smoking for only 1/20 of the 1 million adolescents who become 
new smokers each year would provide annual benefits valued at from $2.9 
to $4.3 billion a year.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 41314                                    08/11/95
NPRM Comment Per60 FR 53560d to 01/02/96                       10/16/95
NPRM Comment Period End                                        11/09/95
Final Action                                                   00/00/00
Jurisdictional Analysis
Notice 08/11/95 (60 FR 41453)
Small Entities Affected:


Businesses


Government Levels Affected:


State


Agency Contact:
Phil Chao
Policy Analyst
Office of Policy (HF-23)
Department of Health and Human Services
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-3380
RIN: 0910-AA48
_______________________________________________________________________
HHS--FDA
30.  REVOCATION OF CERTAIN REGULATIONS
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
eliminate existing text in the CFR.


Legal Authority:


 21 USC 321 to 394; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 467F; 21 
USC 679; 21 USC 821; 21 USC 1034; 42 USC 202; 42 USC 262; 42 USC 263B; 
42 USC 264; 15 USC 1451 to 1461; 5 USC 551 to 558; 5 USC 701 to 721; 28 
USC 2112


CFR Citation:


 21 CFR 100 to 101; 21 CFR 103 to 105; 21 CFR 109; 21 CFR 137; 21 CFR 
161; 21 CFR 163; 21 CFR 182; 21 CFR 186; 21 CFR 197; 21 CFR 505; 21 CFR 
507 to 508; 21 CFR 601; 21 CFR 620; 21 CFR 630; 21 CFR 640 to 660; ...


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is proposing to revoke certain 
regulations that either do not achieve public health goals or do not 
need to be codified as regulations to do so. These regulations include 
regulations that are actually statements of policy or guidance, that 
are duplicative, that are obsolete, or that have been made inaccurate 
by changes in legislation and technology.
FDA is taking this action in response to President Clinton's directive 
of March 4, 1995, to all Federal agencies to conduct a page-by-page 
review of their regulations and to eliminate or revise those that are 
outdated or otherwise in need of reform. As a result of its regulations 
review, FDA is proposing to eliminate 36 percent of its regulations 
that it has determined are obsolete or no longer necessary to achieve 
public health goals (735 pages of which will first require 
Congressional action). In addition, FDA plans to revise or modify an 
additional 45 percent of its remaining regulations to ease the burden 
on regulated industry and the consumer without sacrificing public 
health protection. For those regulations requiring Congressional 
permission to eliminate or reform, the Administration is seeking 
legislation. This proposal contains deletions that can be accomplished 
administratively. Examples include regulations that refer to substances 
no longer used in product formulations or to products that are no 
longer marketed; and regulations that codify product standards that can 
be more flexibly handled and updated within the context of the review 
process. FDA is providing a 90-day period for public comment on these 
proposed deletions.


Statement of Need:


This proposal represents FDA's most recent effort toward achieving for 
all products under its jurisdiction a set of regulations that is leaner 
and more clearly focused. By eliminating regulations that are out of 
date, or duplicative, or that amount to mere statements of policy and 
guidance, the agency is eliminating the potential for confusion with 
respect to its requirements.


Summary of the Legal Basis:


FDA's authority to promulgate and withdraw regulations, as stated in 
the agency's Administrative Practices and Procedures regulations, is 
grounded in the Food, Drug, and Cosmetic Act, the Public Health Service 
Act, and the Fair Packaging and Labeling Act.


Alternatives:


One alternative to revoking the regulations that are the subject of 
this proposal would be to leave them untouched. Inasmuch as these 
regulations have been identified as either no longer serving useful 
public health goals, or as not requiring codification as regulations to 
do so, leaving them intact would amount to allowing them to take up 
space in the Code of Federal Regulations, which is printed at a cost to 
taxpayers, for no useful purpose. Another alternative would be to 
substantially rewrite these regulations in an effort to make them more 
useful. However, if they could be usefully rewritten, these regulations 
would not be proposed for deletion.


Anticipated Costs and Benefits:


FDA finds that this proposed rule is neither an economically 
significant nor significant regulatory action. It would result in no 
new requirements on regulated industries, but would, in many instances, 
delete requirements that are no longer meaningful and out of date and 
that may generate confusion as a result. Information contained in 
regulations that have been identified as statements of policy or 
guidance will continue to be available to the regulated industry. The 
proposed rule raises no new policy issues. Its significance lies in the 
fact that it is part of a larger effort to streamline, clarify, and 
reduce the burden on industry and consumers of FDA regulation with no 
sacrifice in public health protection. The benefit of the proposed 
regulation is that it would simplify and clarify FDA's regulation in 
all product areas.


Risks:


FDA is aware of no risk to public health and safety posed by 
regulations that this proposal would delete. Their deletion would leave 
in the Code of Federal Regulation a body of regulations that would 
provide a clearer statement of regulatory requirements that are needed 
to carry out FDA's mandate.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 53480                                    10/13/95
NPRM Comment Period End                                        01/11/96
Final Action                                                   04/00/96
Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Lisa M. Helmanis
Office of Policy(HF-26)
Department of Health and Human Services
Food and Drug Administration
5600 Fishers Lane Rockville, MD 20857
Phone: 301 443-3480
Fax: 301 443-2946
RIN: 0910-AA54
_______________________________________________________________________
HHS--FDA
31.  STREAMLINING PROCEDURES FOR CHANGES IN PRODUCTION OF 
BIOLOGICS
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 15 USC 1451 to 1461; 21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360c to 360f; 21 USC 360u to 360j; 21 USC 371; 21 USC 374; 
21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262 to 263


CFR Citation:


 21 CFR 601


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is proposing to revise 21 CFR 
601.12, which deals with proposed changes in the production of licensed 
biological products--for example, product labeling, production process, 
equipment, facilities, and responsible personnel. Currently, 
licenseholders must obtain FDA preapproval of all such changes through 
supplements to approved applications. In the proposed revision, FDA 
sets forth a process that is intended to reduce the burden on 
licenseholders by reducing the number of supplements submitted for 
changes and to result in more timely approval of changes in their 
products. The new process creates different mechanisms for reporting 
changes, based on their potential to affect adversely the safety, 
purity, potency, or effectiveness of the product. Proposed procedures 
for reporting changes in production are:
No supplements to approved applications will be required. Firms would 
notify FDA of changes and dates of implementation in an annual report.
License holders would notify FDA not less than 30 days prior to 
implementing a change.
Changes would require FDA approval prior to implementation.


Statement of Need:


The present system has been shown to be burdensome to both 
licenseholders and to FDA in that licenseholders must submit 
supplements for every proposed change, and FDA must review them. The 
present system is also time-consuming--manufacturers may wait from 6 to 
12 months for approval of supplements--and unnecessarily rigid. FDA 
estimates that the proposed system would reduce by 50 percent--from 
1,000 to 500--the number of supplements submitted annually for 
biologics and reviewed by FDA, allowing for more expeditious agency 
review of supplements that are submitted.


Summary of the Legal Basis:


The Public Health Service Act (42 USC 216 et seq.) and the Federal 
Food, Drug, and Cosmetic Act (21 USC 321 et seq.) authorize FDA to 
regulate the distribution of biological products so that the products 
are safe, pure, potent, and effective. These acts authorize FDA to 
promulgate regulations designed to ensure that the public is not 
exposed to biological products that may not be safe, pure, or potent 
for their intended uses. In order to carry out the public health 
protection purposes of the FD&C Act, FDA (a) reviews and approves 
applications for licenses to manufacture biological products; (b) 
inspects establishments involved in manufacturing activities; and (c) 
reviews and approves important changes that have the potential to 
adversely affect the biological product.


Alternatives:


FDA considered two alternatives. The first alternative was allowing 
license holders to submit summary data and a certification of 
validation and lack of adverse effect on the product's safety, purity, 
potency, or efficacy. FDA believes this alternative is appropriate for 
some changes, but not adequate or sufficient for changes with 
substantial potential to have an adverse effect.
The second alternative would have required license holders to keep 
validation data and certification of lack of adverse effect, and 
allowed them to report changes to FDA in annual report. FDA believes 
this alternative is appropriate for changes that have only a minimal 
potential for adverse effect on the product. It is incorporated into 
the proposed revision for such changes.


Anticipated Costs and Benefits:


FDA is specifically requesting comment and information that can be used 
to calculate the costs and benefits to licenseholders. In general, the 
proposed revision is expected to reduce significantly the burden of 
preparing supplements for proposed changes by eliminating this 
requirement for a number of changes. The proposed revision will 
accordingly reduce the number of supplements requiring FDA review and 
allow for more expeditious handling of supplements that are submitted. 
Licenseholders are expected to incur no additional costs as a result of 
the proposal; on the other hand it will allow for more timely 
implementation of changes by licenseholders--for example, streamlining 
and updating manufacturing facilities.


Risks:


FDA believes the risks posed by the proposed new reporting system are 
minimal. In addition to stating in the proposed revision which changes 
are considered to have substantial, moderate, and minimal potential for 
adverse effects, FDA will provide thorough supplementary guidance to 
manufacturers to help assure adequate assessment of the potential for 
adverse effects.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/96
Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Tracey Forfa
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (HFM-630), 1401 Rockville 
Pike
Suite 200N, Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA57
_______________________________________________________________________
HHS--FDA
32.  PROTECTION OF HUMAN SUBJECTS; INFORMED CONSENT
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 352; 21 USC 
353; 21 USC 355 to 357; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 
360j; 21 USC 371; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 381


CFR Citation:


 21 CFR 50; 21 CFR 56; 21 CFR 312; 21 CFR 314; 21 CFR 601; 21 CFR 812; 
21 CFR 814


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is proposing to amend its 
current informed consent regulations to permit harmonization of FDA and 
National Institutes of Health (NIH) policies on emergency research, and 
to reduce confusion as to when such research can proceed without 
obtaining informed consent. The regulation provides a narrow exception 
to the requirement for obtaining and documenting informed consent from 
each human subject prior to initiation of an experimental treatment. 
The exception would apply to a limited class of research activities 
involving human subjects who, because of their life-threatening medical 
condition and the unavailability of legally authorized persons to 
represent them, are in need of emergency medical intervention and 
cannot provide legally effective informed consent.
The proposed rule would permit an Institutional Review Board (IRB) to 
approve an emergency research protocol if the IRB finds and documents 
that (a) the human subjects will be in a life-threatening situation, 
available treatments are unproven or unsatisfactory, and the collection 
of valid scientific evidence is necessary to determine what particular 
treatment is most beneficial; (b) obtaining informed consent is not 
feasible; (c) the opportunity for the subjects to participate in the 
research is in the interest of the subjects because treatment is 
required, and the risk is ``reasonable'' given what is known about the 
risks and benefits of experimental treatment, the current therapy, and 
the medical condition; (d) the research could not practically be 
carried out without the waiver; (e) additional protection of the rights 
and welfare of the subjects will be provided; and, (f) the IRB has 
reviewed and approved an informed consent document for use with 
subjects for whom consent is possible.
The proposed rule provided that, when possible and at the earliest 
possible opportunity, each subject will be informed about the details 
of the study and permitted to discontinue participation at any time 
without penalty. The rule also incorporates additional patient 
protections, including: FDA review of the protocol; consultation with 
representatives of the communities from which the subjects will be 
drawn; public disclosure prior to the study sufficient to describe the 
study and its risks and benefits; the establishment of an independent 
data and safety monitoring board; and public disclosure following 
completion of the study sufficient to apprise the community and 
researchers of the study and its results.
FDA, in coordination with NIH, developed this proposal because of 
concerns expressed by the research community and patient advocacy 
groups that emergency research is at a virtual halt pending a revision 
of both FDA's informed consent regulations and a waiver of HHS 
regulations for the protection of research subjects. HHS intends to 
bring both policies into harmony on this matter at the time this rule 
is made final.


Statement of Need:


FDA is proposing this action in response to growing concerns that 
current rules are making high-quality acute care research activities 
difficult or impossible to carry out at a time when the need for such 
research is increasingly recognized. There are many conditions, such as 
heart attacks, closed head wounds, and spinal cord injuries, where 
current medicine cannot save many of the patients. For example, each 
year, approximately 350,000 people in the United States suffer a sudden 
cardiac arrest. Most die, while many others are irreversibly harmed by 
complications such as brain damage. Given the large number of sudden 
cardiac arrests annually in the United States alone, even small 
improvements in care offer enormous life-saving potential. This 
proposed rule is intended to permit emergency care professionals to 
conduct appropriately designed clinical trials to validate or discredit 
current or innovative treatments.


Summary of the Legal Basis:


Sections 505(i), 507(d), and 520(g) of the Federal Food, Drug, and 
Cosmetic Act direct the Secretary (and, in accordance with section 903 
of the act (21 USC 394), FDA) to issue regulations establishing 
conditions under which investigational use of drugs and devices by 
qualified experts will be permitted. For drugs (including biological 
drugs and antibiotics) and devices, the statute specifies that the 
agency must include among these conditions that the product 
manufacturer or sponsor require the expert studying the product to 
obtain informed consent from the subjects or their representatives. The 
only exceptions from the informed consent requirement for drugs are 
where the investigators ``deem it not feasible or, in their 
professional judgment, contrary to the best interests'' of the subjects 
(sections 505(i) and 507(d) of the act). The only exceptions from the 
informed consent requirements for devices are where the investigator 
determines ``there exists a life threatening situation involving the 
human subject of such testing which necessitates the use of such device 
and it is not feasible to obtain informed consent from the subject and 
there is not sufficient time to obtain such consent from his 
representative'' (section 520(g)(3)(D) of the act). In addition, 
``unless immediate use of the device is required to save the life of 
the human subject,'' and there is insufficient time to obtain the 
concurrence of a licensed physician must concur in the determination. 
The exceptions to require informed consent are ``subject to such 
conditions as the Secretary may prescribe.'' The agency has analyzed 
the provisions of the proposed rule and found that they satisfy all of 
the statutory criteria of sections 505(i), 507(d), and 520(g) of the 
act for permitting exceptions to the informed consent requirements for 
investigational drug and device use.


Alternatives:


FDA considered whether a reinterpretation of its existing regulations 
would meet the needs of persons in life-threatening situations and the 
research community. It concluded against such a reinterpretation for a 
number of reasons, including: it would not make the FDA regulations and 
the HHS regulations congruent; it would not provide prospective 
protections to subjects participating in such research; it would be 
difficult if not impossible to enforce additional safeguards that the 
agency believes are essential to protect subjects involved in such 
research activities; and it would not adequately eliminate the 
confusion that currently exists within the research community as to the 
standards that must be applied to this research. The sole benefit of a 
reinterpretation of existing regulations would be to permit this 
limited class of research to move forward quickly, rather than delaying 
until a new regulation could be written. The agency has, thus, placed 
priority on developing this proposed regulation in order to permit the 
ethical conduct of a limited class of emergency research.


Anticipated Costs and Benefits:


FDA does not believe that this rule will have a significant economic 
impact on a substantial number of small entities. This is because this 
proposed rule is a deregulatory action insofar as it will permit 
research to proceed which could not proceed under existing regulations, 
and because relatively few research projects will need to meet the 
requirements of this rule.
By permitting certain controlled clinical trials to be conducted with 
the involvement of human subjects who are confronted by a life-
threatening condition and who are also unable to give informed consent 
because of that condition, the agency expects to provide individual 
access to potentially beneficial treatment. The agency also expects 
that research to result in advancement and improvement of therapies 
used in emergency medicine situations that currently have poor clinical 
outcome. As a result of this rule, many individuals confronted by life-
threatening situations will benefit immediately. Survival of these 
individuals may be enhanced by their participation in controlled 
trials. As described previously, there are many conditions where 
current medicine cannot save many of the patients. For example, each 
year, approximately 350,000 people in the United States suffer a sudden 
cardiac arrest. Even small improvements in emergency medical care 
offers enormous life-saving potential.


Risks:


Modern trauma care is based on the ``golden hour'' following acute 
injury. Most patients who die from injury in the first 24 hours do so 
from processes set in motion at the time of injury. Because of this, 
any therapeutic intervention must be begun immediately to interrupt the 
injury-induced cascade of body reactions that lead to death. There are 
many conditions, such as heart attacks, closed head wounds, and spinal 
cord injuries, where current medicine cannot save many of the patients. 
For example, currently, despite efforts to instill basic life support 
education, only a small percentage of individuals who suffer sudden 
out-of-hospital cardiac arrests are resuscitated by bystanders. Few 
survive to leave the hospital. This percentage may be as low as 1 to 3 
percent in some large metropolitan areas, with the best results 
estimated to be only in the 25 percent range. Given the large number of 
sudden cardiac arrests annually in the United States alone, even small 
improvements in care offer enormous life-saving potential.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 49086                                    09/21/95
NPRM Comment Period End                                        11/06/95
Final Action                                                   09/00/96
Small Entities Affected:


None


Government Levels Affected:


None


Agency Contact:
Glen D. Drew
Department of Health and Human Services
Food and Drug Administration
Office of Health Affairs (HFY-20) 5600 Fishers Lane Rockville, MD 20857
Phone: 301 443-1382
RIN: 0910-AA60
_______________________________________________________________________
HHS--FDA
33.  MEDICAL DEVICE EXEMPTIONS FROM PREMARKET NOTIFICATION
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 21 USC 351; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 360j; 21 USC 
371


CFR Citation:


 21 CFR 862; 21 CFR 866; 21 CFR 868; 21 CFR 870; 21 CFR 872; 21 CFR 
874; 21 CFR 876; 21 CFR 878; 21 CFR 880; 21 CFR 882; 21 CFR 884; 21 CFR 
886; 21 CFR 888; 21 CFR 890; 21 CFR 892


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) regulates some 1,700 types of 
medical devices and places them in classes, depending on the level of 
risk they present. Currently, manufacturers of most medical devices are 
required to submit information to FDA and receive FDA clearance before 
putting a device on the market, even if the device poses an extremely 
low risk. FDA has determined that, for devices that pose a low level of 
risk to patients, review is not necessary to protect the public health, 
places an unnecessary regulatory burden on device manufacturers, and 
delays introduction of new devices.
Accordingly, FDA is proceeding, through notice and comment rulemaking, 
to exempt low-risk medical devices from premarket notification 
requirements. Of these, 450 types of low-risk devices (such as 
stethoscopes, hernia supports, and surgical microscopes) have already 
been exempted. On July 28, 1995, FDA proposed to exempt 12 more types 
of low-risk devices and, at the same time, to reclassify an additional 
112 types of devices as low-risk (Class I) and to exempt them from 
premarket notification requirements as well. FDA receives some 700 
submissions each year for devices in the categories affected by this 
rulemaking and will be able to redirect resources for the review of 
these products to more complex products. This final regulation will 
complete the rulemaking, at which time one-third of all categories of 
devices will be exempted from premarket notification requirements. 
Examples of affected devices include arterial blood sampling kits, 
therapeutic humidifiers for home use, dental floss, and otoscopes for 
examining the ear.


Statement of Need:


Premarket notification is burdensome to manufacturers of low-risk 
devices, and review of such notification is time-consuming, delaying 
marketing of the devices, and represents an inefficient use of FDA 
resources. Exempting low-risk devices from premarket notification 
allows new devices to be brought to market more quickly and allows FDA 
to use its resources to better protect the public health.


Summary of the Legal Basis:


Section 513(d) of the Food, Drug, and Cosmetic Act (21 USC 360d) 
authorizes FDA to exempt, by regulation, a generic type of class I 
device from, among other things, the requirement of premarket 
notification in section 510(k) of the act (21 USC 360K). Pursuant to 
section 513(e)(1) of the act, based on new information respecting a 
device, FDA may, upon its own initiative, by regulation change a 
device's classification and revoke, because of the change in 
classification, any regulation or requirement in effect with respect to 
such device under sections 514 or 515 of the act (21 USC 360d or 21 USC 
360e).


Alternatives:


The exemption process is an ongoing one, and 450 categories of devices 
have been exempted so far. This action has reduced burden on 
manufacturers, allowed FDA resources to be redirected more usefully, 
and has not been shown to affect public health protection. The 
alternative to the exemptions and reclassifications included in this 
regulation would be to do nothing, in effect, and continue to require 
premarket notification. This has been shown to be burdensome to 
manufacturers and to make inefficient use of FDA resources without 
offering meaningful public health protection.


Anticipated Costs and Benefits:


The proposal will not impose any costs on manufacturers, but will 
relieve them of the burden of submitting premarket notification 
submissions for certain devices. FDA will also benefit by receiving 
approximately 700 fewer submissions per year and will be able to 
redirect its resources to more complex products.


Risks:


In view of the low level of risk presented by these devices, the 
likelihood of their causing harm or injury to patients is slight. 
Exemption from premarket notification is not an exemption from any of 
the other general controls under the act, including current good 
manufacturing practices. In addition, under the reporting provisions of 
the Safe Medical Devices Act, actual or probable harm to patients and 
malfunction must be reported to FDA, and thus FDA will be able to 
monitor these devices and take appropriate remedial action if 
necessary.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 38902                                    07/28/95
NPRM Comment Period End                                        10/11/95
Final Action                                                   12/00/95
Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Joseph M. Sheehan
Chief, Regulations Staff
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health (HFZ-84)
2098 Gaither Rd., Rockville, MD 20874
Phone: 301 594-4765
RIN: 0910-AA65
_______________________________________________________________________
HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------

34. FINAL REGULATION TO ESTABLISH PROCEDURES FOR THE SAFE AND SANITARY 
PROCESSING AND IMPORTING OF FISH AND FISHERY PRODUCTS
Priority:


Economically Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 21 USC 342 Federal Food, Drug, and Cosmetic Act; 21 USC 371 Federal 
Food, Drug, and Cosmetic Act; 21 USC 374 Federal Food, Drug, and 
Cosmetic Act; 42 USC 264 Public Health Service Act; 21 USC 321; 21 USC 
343; 21 USC 346; 21 USC 348; 21 USC 379e; 21 USC 381; 42 USC 241; 42 
USC 242l; 42 USC 300u-l; 42 USC 216; 42 USC 243


CFR Citation:


 21 CFR 123; 21 CFR 1240


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is adopting regulations to 
ensure the safe and sanitary processing and importing of fish and 
fishery products. These procedures include the monitoring of selected 
processes in accordance with Hazard Analysis Critical Control Point 
(HACCP) principles. HACCP is a preventive system of hazard control that 
can be used by food processors. FDA is adopting these regulations 
because a system of preventive controls is the most effective and 
efficient way to ensure that these products are safe.


Statement of Need:


Ensuring the safety of seafood to consumers poses a unique challenge to 
both the industry that produces it and to regulators. Seafood involves 
more than 300 highly diverse species from around the world. It is the 
most perishable of all flesh foods. As stocks of traditionally consumed 
fish decline, the pressure to find new species increases. Most seafood 
is still wild caught, the range of possible human food safety hazards 
includes every hazard in the marine environment as well as those 
associated with aquaculture. It is essential that those who process 
seafood for consumers understand the hazards and the controls for those 
hazards. As a general rule, however, such knowledge is not a 
prerequisite for doing business. Preventive controls for ensuring 
safety are not always employed and good sanitation is not always 
practiced. Preventable illnesses from seafood do occur. Moreover, it is 
questionable whether the current regulatory system, which was developed 
for the general food supply, is best suited for the seafood industry. 
The current system provides the agency with a ``snapshot'' of 
conditions at a facility at the moment of the inspection. The 
reliability of the regulators' assumptions about conditions in the 
plant during the intervals between inspections creates legitimate 
concerns about the adequacy of the system. Moreover, the system places 
an undue burden on the regulator to find problems, rather than placing 
responsibility on the industry to demonstrate that it understands the 
human food safety hazards and is employing appropriate controls for 
those hazards. The HACCP system solves these problems. Processors 
design preventive controls that are tailored to their products and 
processes. In accordance with HACCP principles, these controls provide 
processors with immediate information about whether they are 
controlling hazards. The records generated by the monitoring of 
critical control points enable the plant and the regulator to observe 
key safety operations over time, rather than at a single moment.


Summary of the Legal Basis:


FDA's application of HACCP is intended for the efficient enforcement of 
sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act, which applies to products that contain substances that 
may render the product injurious to health and to processing conditions 
that are insanitary and that could render a product injurious to 
health.


Alternatives:


Continuing the current system of highly generalized good manufacturing 
practices (GMPs) for seafood processors and intermittent inspections 
based on these GMPs would be less efficient and effective than a HACCP-
based system for the reasons stated above. Continuous visual inspection 
is not a viable alternative. Few hazards associated with seafood are 
detectable through visual inspection. Moreover, the costs of such a 
system would likely exceed the nearly half-billion dollar public outlay 
now required to operate this kind of system for meat and poultry.
Another alternative would be to direct significant additional resources 
toward greatly increasing the frequency of FDA's inspection of seafood, 
as well as increasing the agency's sampling, laboratory analysis, and 
related regulatory activities with respect to seafood. Even if the 
funds for increased inspection and sampling were available, this 
approach alone would not be the best way for the agency to spend its 
resources on protecting the public health because the current form of 
inspection is inherently less efficient and effective than a HACCP-
based inspection. Increased reliance on end-product testing, moreover, 
would involve a certain amount of inefficiency that would require very 
large sample sizes to overcome.


Anticipated Costs and Benefits:


Costs, first year, 69 million to 168 million, benefits first year 73-
108 million, total discounted costs at 6 percent discounting: 677 
million to 1,488 million. Total discounted benefits at 6 percent: 1,435 
million to 2,561 million.


Risks:


If this regulation is not adopted the U.S. industry will lose or be 
significantly hampered in exporting to the European Union market. In 
addition an opportunity to adopt an efficient and highly effective 
means of manufacturing and monitoring the safety of seafood will be 
lost. Finally, a major opportunity to significantly reduce the number 
of seafood related illnesses in the United States will also have been 
lost.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            59 FR 4142                                     01/28/94
NPRM Comment Period End                                        03/29/94
Final Action                                                   12/00/95
Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


Previously reported under RIN 0905-AD60.
42 USC 264; 42 USC 271


Agency Contact:
Philip Spiller
Deputy Director, Office of Seafood
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-401), 200 C Street 
SW.
Washington, DC 20204
Phone: 202 418-3133
RIN: 0910-AA10
_______________________________________________________________________
HHS--FDA
35. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE
Priority:


Other Significant


Legal Authority:


 21 USC 321; 21 USC 352; 21 USC 371; 21 USC 355; 42 USC 262


CFR Citation:


 21 CFR 201; 21 CFR 208; 21 CFR 314; 21 CFR 600


Legal Deadline:


None


Abstract:


Inadequate access to appropriate patient information is a major cause 
of inappropriate use of prescription medications, resulting in serious 
personal injury and related costs to the health care system. The Food 
and Drug Administration (FDA) believes that it is essential that 
patients receive information accompanying dispensed prescription drugs. 
This information needs to be widely distributed and be of sufficient 
quality to promote the proper use of prescription drugs. Therefore, FDA 
is proposing performance standards that would define acceptable levels 
of information distribution and quality, and to assess supplied 
information according to these standards. In accordance with the 
Administration's philosophy of fairly assessing a voluntary approach 
before imposing requirements through regulations, FDA is proposing that 
this information be disseminated through voluntary private-sector 
initiatives. Preliminary evidence suggests recent increases in the 
distribution of privately produced patient medication information with 
dispensed prescriptions; however, estimated distribution rates indicate 
that significant numbers of patients still do not receive information 
with their medications. FDA analyses also indicate that there is a high 
variablility in the quality of this information. FDA believes that, 
with greater encouragement and clear objectives, the private sector 
will substantially improve the quality and distribution of patient 
information. Therefore, in concert with Healthy People 2000, FDA is 
proposing that private-sector initiatives meet the goal of distributing 
useful patient information to 75 percent of individuals receiving new 
prescriptions by the year 2000 and 95 percent of individuals receiving 
new prescriptions by the year 2006. FDA is proposing two alternative 
approaches to help ensure that these goals (performance standards) are 
achieved. FDA would periodically evaluate and report on achievement of 
these goals. If the goals are not met in the specified timeframes, FDA 
would either (a) implement a mandatory comprehensive Medication Guide 
program, or (b) seek public comment on whether the comprehensive 
program should be implemented or whether, and what, other steps should 
be taken to meet patient information goals.
Regardless of the approach chosen, a mandatory Medication Guide program 
would initially be limited to instances where a product poses a serious 
and significant public health concern requiring immediate distribution 
of FDA-approved patient information. FDA believes that substantial 
health care cost savings can be realized by ensuring that consumers 
obtain the inherent benefits of proper use of prescription drugs, and 
by reducing the potential for harm caused by inappropriate drug use by 
the patient.


Statement of Need:


A fundamental principle of an effective health care system is that 
patients have a right and responsibility to participate actively in 
decisions affecting their own health. This requires that patients 
receive their own information, including information about their 
medicines. Despite the existence of numerous voluntary programs 
designed to improve patient knowledge, however, FDA has concluded that 
the number of consumers who receive patient information with their 
prescription drug products is unacceptably low. This rule will 
establish a program of patient information distribution through 
voluntary programs that is designed to ensure that consumers achieve 
maximum benefits from the use of prescription drugs and reduce the 
potential for harm caused by inappropriate patient drug use.
FDA is proposing that useful written information, in nontechnical 
language that is directed to the patient, be developed by the private 
sector for dispensing with prescription drug and biological products 
that are used primarily on an outpatient basis without direct 
supervision by a health care professional. The patient labeling would 
inform the patient about the drug product and would include information 
such as the product's approved uses, contraindications, proper 
administration, adverse drug reactions, and cautions for specific 
populations (including pregnant women and children).


Summary of the Legal Basis:


The Federal Food, Drug and Cosmetic Act (21 USC 321 et seq.) authorizes 
FDA to regulate the marketing of drug products so that the products are 
safe and effective for their intended uses and are properly labeled. In 
order to carry out the public health protection purposes of the act, 
FDA (a) monitors drug manufacturers and distributors to help make 
certain that drug products are manufactured and distributed under 
conditions that ensure their identity, strength, quality, and purity; 
(b) approves new drugs for marketing only if they have been shown to be 
safe and effective; and (c) monitors drug labeling and prescription 
drug advertising to help ensure that they provide accurate information 
about drug products.
The act authorizes FDA to promulgate a regulation designed to ensure 
that patients using prescription drugs will receive information that is 
material with respect to the consequences which may result from the use 
of a drug product under its labeled conditions. This interpretation of 
the act and the agency's authority to require patient labeling for 
prescription drug products has been previously upheld.


Alternatives:


FDA considered several alternative programs that could meet the 
objectives of this proposed regulation.
One alternative was to offer patients access to patient labeling 
through a catalogue or computer data base at the pharmacy or 
practitioner's office, but not necessarily dispense individual labeling 
with each product. FDA decided against this alternative because not all 
patients would be aware of or able to obtain sufficient information 
about the drug product, and because the information is needed at home 
where the drug product is consumed.
A second alternative was to provide patient labeling with both new and 
refill prescriptions. FDA decided against this alternative because of 
the relatively large economic burden it would place on pharmacists.


Anticipated Costs and Benefits:


FDA has analyzed the economic consequences of the proposed rule and has 
determined that patient labeling will have associated costs well below 
the $100 million threshold that defines a significant regulatory 
action. However, even though the rule is below this threshold, in 
accordance with Executive Order 12866 and the Regulatory Flexibility 
Act (Pub. L. 96-354), FDA has developed a preliminary regulatory impact 
analysis (PRIA). The PRIA concludes that, even when utilizing very 
conservative benefit estimates, implementation costs will be more than 
offset by the health care savings that result from an increase in 
compliance with prescribed drug therapy, and a decrease in the number 
of adverse drug reactions.


Risks:


FDA has concluded from a review of the current literature that patient 
noncompliance with prescribed drug regimens ranges from 30 to 50 
percent. Patients who do not comply with prescribed regimens are 
subject to two types of risks: risk of therapeutic failure and risk of 
adverse drug reaction or drug interaction with other drugs and foods. 
Both types of risk are potentially very serious. The seriousness of 
therapeutic failure depends on the seriousness of the illness being 
treated, while the effects of drug reaction or interaction may range 
from mild and transitory to long-lasting and even life-threatening.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 44182                                    08/24/95
Final Action                                                   06/00/96
Small Entities Affected:


Businesses


Government Levels Affected:


State, Federal


Additional Information:


Previously reported under RIN 0905-AE43.


Agency Contact:
Louis A. Morris
Chief
Marketing Practices & Communication Branch
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (HFD-240), 5600 Fishers Lane
Rockville, MD 20857
Phone: 301 594-6828
RIN: 0910-AA37
_______________________________________________________________________
HHS--Health Resources and Services Administration (HRSA)

                              -----------

                            FINAL RULE STAGE

                              -----------

36. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES
Priority:


Other Significant


Legal Authority:


 42 USC 1320b-8 sec 1138 of the Social Security Act; 42 USC 274 sec 372 
of the Public Health Service Act


CFR Citation:


 42 CFR 121


Legal Deadline:


None


Abstract:


Section 1138 of the Social Security Act requires Medicare and Medicaid 
participating hospitals that perform organ transplants to be members of 
and abide by the rules and requirements of the Organ Procurement and 
Transplantation Network (OPTN) as established by section 372 of the 
Public Health Service Act. Section 1138 also requires that for organ 
procurement costs attributable to payments to an Organ Procurement 
Organization (OPO) to be paid by Medicare or Medicaid, the OPO must be 
a member of and abide by the rules and requirements of the OPTN. No 
other entity (for example, a histocompatibility laboratory) is required 
to be a member of or abide by the rules of the OPTN under the 
provisions of the statute. It is the Department's position that no 
rule, requirement, policy, or other issuance of the OPTN will be 
considered to be a ``rule or requirement'' of the Network within the 
meaning of section 1138 unless the Secretary has formally approved that 
rule. The OPTN is currently in operation and these rules will impose no 
further cost or provide any benefit other than that which now exists.


Statement of Need:


These regulations are required by law.


Summary of the Legal Basis:


Section 1138 of the Social Security Act (42 USC 1320b-8) requires 
Medicare and Medicaid participating hospitals that perform organ 
transplants to be members of and abide by the rules and requirements of 
the Organ Procurement and Transplantation Network (OPTN) as established 
by section 372 of the Public Health Service Act (42 USC 274).


Alternatives:


The alternative was to continue without codifying existing policies.


Anticipated Costs and Benefits:


There are no anticipated costs beyond the cost of preparing the 
regulations (approximately $100,000.00). The anticipated benefit is 
that the regulations will make mandatory adherence to the policies set 
forth in the regulations.


Risks:


None known.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            59 FR 46482                                    09/08/94
NPRM Comment Per59 FR 46482                                    12/07/94
Final Action                                                   03/00/96
Small Entities Affected:


None


Government Levels Affected:


None


Additional Information:


Previously reported under RIN 0905-AD26.


Agency Contact:
Judy Braslow
Director, Division of Organ Transplantation
Bureau of Health Resources Development
Department of Health and Human Services
Health Resources and Services Administration
Room 7-18 Parklawn Bldg.
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 443-7577
RIN: 0906-AA32
_______________________________________________________________________
HHS--Indian Health Service (IHS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

37. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS
Priority:


Other Significant


Legal Authority:


 PL 93-638; PL 100-202; PL 100-446; PL 100-472; PL 100-581; PL 101-301; 
PL 103-413; 25 USC 450


CFR Citation:


 42 CFR 36; 48 CFR 380.4; 48 CFR 352.280-4


Legal Deadline:


 Final, Statutory, March 1996.


Abstract:


Public Law 93-638, passed in 1975, requires the Indian Health Service 
(IHS) to turn over administrative responsibility for service delivery 
programs to tribes so requesting, using the mechanism of contracting. 
Public Law 93-638 also authorizes the IHS to make grants to tribes for 
the planning, development, and/or operations of health programs. Public 
Law 100-472, enacted October 5, 1988, made significant changes to the 
statute and required that regulations implementing the amendments be 
promulgated in final within 10 months of enactment. The NPRM was 
published on January 20, 1994. The 120-day comment period was extended 
until August 20, 1994. On October 26, 1994, Public Law 103-413 was 
enacted. These amendments superseded the published NPRM and authorized 
the Secretaries of Interior and Health and Human Services to publish 
joint regulations only in specified areas. These regulations would be 
developed using the negotiated rulemaking procedure and are to be 
published within 18 months of the passage of the authorizing 
legislation.


Statement of Need:


In response to the long-standing Indian interest in self-determination, 
Congress enacted the Indian Self-Determination and Education Assistance 
Act in 1975. The Indian people have long sought more meaningful 
participation in the planning, conduct, and administration of their 
programs and devices. The Act reflects a commitment to preserving the 
Federal relationship with and responsibility to the Indian people by 
promoting efforts to transfer the operation of service delivery 
programs of the Federal Government to Indian tribes. The 1975 Act 
requires the Indian Health Service (IHS) to contract with Indian tribal 
organizations for the operation of IHS service delivery programs.
The Act also authorizes IHS to make grants to tribes for the planning, 
development, and/or operation of Health Programs. On October 5, 1988, 
Congress amended the Act to expand its coverage and authorize a new 
nonprocurement contracting process which required revision of existing 
regulations. The Amendments (Public Law 100-472) provided that the 
regulations be developed with the participation of and in consultation 
with Indian tribes and tribal organizations.


Summary of the Legal Basis:


As mentioned above, on October 26, 1994, Public Law 103-413 was 
enacted. The amendments superseded the published NPRM and authorized 
the Secretaries of Interior and Health and Human Services to publish 
joint regulations only in specified areas.


Alternatives:


Public Law 103-413 authorizes the secretaries of Interior and HHS to 
publish joint regulations in certain specified areas, but does not 
require publication of any regulation. Regulations are under 
development using the negotiated rulemaking process. Therefore, the 
Secretaries and the tribes will jointly determine the nature and extent 
of the regulations.


Anticipated Costs and Benefits:


No additional costs are associated with this regulation. It is 
anticipated that Indian tribes and tribal organizations will benefit 
from having regulations required for ``638'' contracts and grants in 
one title of the Code of Federal Regulations.


Risks:


There are no public health risks addressed by this rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/95
NPRM Comment Period End                                        01/00/96
Small Entities Affected:


None


Government Levels Affected:


Tribal


Additional Information:


Previously reported under RIN 0905-AE68.


Agency Contact:
Betty J. Penn
Chief, Regulations Branch, DLR
Department of Health and Human Services
Indian Health Service
12300 Twinbrook Parkway
Suite 450
Rockville, MD 20852
Phone: 301 443-1116
RIN: 0917-AA01
_______________________________________________________________________
HHS--Health Care Financing Administration (HCFA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

38. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-819-P)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 
1395bbb


CFR Citation:


 42 CFR 484


Legal Deadline:


None


Abstract:


This proposed rule would revise home health agency conditions of 
participation to center on the patient, using outcome-oriented 
measures. Most of the current HHA conditions of participation have 
remained unchanged since home health services became a Medicare benefit 
in 1966. Some limited modifications have been made over the years to 
comply with legislative changes. As a result, most of the conditions of 
participation continue to be structure and process oriented. They do 
not effectively support the mandate of the Omnibus Budget 
Reconciliation Act of 1987 (OBRA '87) to develop a patient-centered, 
outcome-oriented survey process that focuses on the organization and 
delivery of quality care services. This proposed rule is part of HCFA's 
regulatory reform initiative.


Statement of Need:


Most of the current HHA conditions of participation have remained 
unchanged since home health services became a Medicare benefit in 1966. 
Some limited modifications have been made over the years to comply with 
legislative changes. As a result, most of the conditions of 
participation continue to be structure and process oriented. They do 
not effectively support the mandate of OBRA '87 to develop a patient-
centered, outcome-oriented survey process which focuses on the 
organization and delivery of quality care services.
Because the existing survey process continues to focus on structure and 
process measures, the discrepancy between a congressional mandate for 
outcome-oriented care and the authority for measuring the actual 
performance capabilities of HHAs in patient care services remains a 
problem. It presents difficulties for both providers and surveyors in 
areas of survey/certification, medical review, developing data based 
performance standards for HHA management and monitoring, and 
implementing a continuous quality improvement system for outcomes of 
care.
Regulations containing the Medicare HHA conditions of participation 
must be revised in order to provide a regulatory basis for a patient-
centered, outcome-oriented system of home health quality assurance. The 
implementation of such a system will enhance Medicare's ability to 
ensure that high-quality care is furnished to the patients of Medicare-
certified home health agencies. The Social Security Act authorizes us 
to regulate this area and no improvements in the survey process can be 
made without underlying regulatory authority.
The Health Care Financing Administration has already met with a variety 
of provider and consumer representatives to discuss the development of 
revised standards. Representatives of consumers, providers, and States 
participated in this effort. Additional consultations are ongoing and 
will continue during the development of the regulation.


Alternatives:


Congress has mandated the implementation of an outcome-oriented quality 
assurance system for home health. Therefore, the Medicare home health 
agency conditions of participation must be revised to provide the basis 
for implementation of such a system.
Because of this mandate, no alternatives to this action have been 
considered.


Anticipated Costs and Benefits:


The primary benefit of this rule will be the implementation of a more 
effective, efficient, and patient-centered system of quality assurance 
for HHAs. Costs and benefits associated with the implementation of the 
rule have not yet been estimated, but costs should not be significant.


Risks:


This rule would have the potential for reducing risks to patient health 
and safety. No quantitative estimates are available yet.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/95
Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Undetermined


Agency Contact:
Susan Levy
Health Insurance Specialist
Department of Health and Human Services
Health Care Financing Administration
C4-05-27
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4637
RIN: 0938-AG81
_______________________________________________________________________
HHS--HCFA
39. END-STAGE RENAL DISEASE (ESRD) CONDITIONS OF COVERAGE (BPD-818-P)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 1395rr


CFR Citation:


 42 CFR 405


Legal Deadline:


None


Abstract:


This proposed rule would revise current conditions of coverage for end-
stage renal disease (ESRD) services covered by Medicare. It would 
update the conditions to reflect new developments in outcome-oriented 
standards technology and equipment, emphasize the total patient 
experience with dialysis and develop performance expectations for the 
facility that result in quality, comprehensive care for the dialysis 
patient. This rule is part of HCFA's regulatory reform initiative.


Statement of Need:


Section 1881(b)(1) of the Social Security Act stipulates that payment 
is made to individuals, providers of services, and renal dialysis 
facilities that meet the requirements for institutional dialysis 
services and supplies that are determined by the Secretary. These 
requirements are the end-stage renal disease (ESRD) conditions of 
coverage.
The ESRD conditions-of-coverage regulations have not been 
comprehensively revised since the regulation's inception in the late 
1970s. The current regulations are written in an outdated style that 
primarily focuses on process-oriented requirements, which are 
unnecessarily burdensome. They do not provide adequate support for a 
modern survey system based on an outcome-oriented approach. As a 
result, revised regulations must be issued to bring the ESRD coverage 
conditions up to current standards of practice in the ESRD community. 
The revised regulations must reflect new developments in technology and 
equipment, as well as addressing the outcome-oriented standards 
process.
The regulations need to be revised to reflect the innovations in the 
dialysis and transplant community. The purpose of revising the 
regulations is to focus on the patient and the results of the care 
provided to the patient. Thus, the emphasis should be on the total 
patient experience with dialysis and quality improvement. The revised 
regulations should focus on patient-centered, outcome-oriented 
standards where appropriate. In addition, they should emphasize patient 
functional well-being and indicate continuous quality improvement. 
Patient rights and satisfaction will also be key areas in the 
regulation. The revised regulations would develop performance 
expectations for the facility that would result in quality, 
comprehensive care for the dialysis patient.
The Health Care Financing Administration held an industry meeting to 
discuss the focus of the conditions of coverage revision. Additional 
discussions with the ESRD community will occur during the regulations 
process.


Alternatives:


In the past, HCFA has revised portions of the ESRD regulations. 
However, it was determined that a complete and thorough revision would 
be a more effective mechanism for developing a comprehensive approach 
to quality care for the dialysis patient. In addition, this approach 
provides the regulation with greater potential for future application. 
Another option is to update the current regulations and maintain the 
process-oriented standards without developing an outcome-oriented 
approach. However, we believe it is important now to move forward with 
the outcome-oriented approach.


Anticipated Costs and Benefits:


The purpose of this final rule is to ensure that ESRD beneficiaries are 
receiving quality care in both the areas of dialysis and 
transplantation. We believe that this regulation is a necessary step to 
ensure that all facilities are using the most effective technology and 
equipment. The primary benefit of updating the conditions of coverage 
is the development of performance expectations for the facility that 
will result in the comprehensive, integrated care and outcomes the 
patient needs and wants. As a result, the beneficiaries will receive an 
improved quality of care. In addition, the revised regulations will 
address the issue of adequacy of dialysis, and this would have a 
significant impact on ensuring that patients are not being 
underdialyzed.
Items that have the potential to affect the cost of the ESRD program 
include data gathering and infection control. However, at this time the 
cost or savings to the Medicare program are speculative.


Risks:


If the ESRD regulations are not updated, the regulations will not 
reflect new developments in technology and equipment, thereby denying 
the improved protections to patients' health care that would result 
from this proposed rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/96
Small Entities Affected:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Lynn Merritt-Nixon
Office of Hospital Policy
Department of Health and Human Services
Health Care Financing Administration
C5-05-15
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4652
RIN: 0938-AG82
_______________________________________________________________________
HHS--HCFA
40. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW SUBCATEGORY 
OF MODERATE COMPLEXITY TESTING (HSQ-222-P)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 263a


CFR Citation:


 42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.18; 42 CFR 
493.20; 42 CFR 493.21; 42 CFR 493.25; 42 CFR 493.43; 42 CFR 493.45; 42 
CFR 493.48; 42 CFR 493.49; 42 CFR 493.51; 42 CFR 493.53; 42 CFR 493.638


Legal Deadline:


None


Abstract:


This rule would develop criteria for simple and easy-to-use test 
systems that have demonstrated accuracy and precision through 
scientific studies. It would waive the routine 2-year survey of users 
of accurate and precise technology (APT) tests, conducting surveys only 
if there are indications of problems or complaints. A small number of 
surveys would be conducted to validate the criteria for determining APT 
and to assure quality.


Statement of Need:


This rule would add a subcategory of moderate complexity tests called 
``accurate and precise technology'' (APT) tests that clinical 
laboratories may perform under the CLIA program. These tests would have 
to meet less stringent requirements because they will have demonstrated 
accuracy and precision through scientific studies evaluated by the 
Centers for Disease Control and Prevention. The purpose of adding this 
subcategory is to provide regulatory relief to laboratories that 
perform testing using methodologies that have been determined to be 
precise and accurate.


Summary of the Legal Basis:


The proposal, based on consultation and in response to public comments, 
establishes less stringent regulatory requirements for tests that have 
demonstrated accuracy and precision through scientific studies.


Alternatives:


Laboratories would have to meet the requirements applicable to moderate 
complexity testing, incurring expenses for personnel, paperwork, and 
routine biennial inspections. Continual regulatory updates would be 
required to reflect innovative technological advances. The performance 
standards currently in place would potentially limit technology.


Anticipated Costs and Benefits:


This rule creates incentives for manufacturers to develop more reliable 
testing equipment by stimulating demand for accurate and precise 
technological testing systems. It reduces paperwork and costs for 
providers, especially for physician office laboratories, as well as 
reducing costs of program management. It includes specific requirements 
for the test system manufacturer or producer to include instructions to 
laboratories for meeting the CLIA requirements, thus lessening 
operating requirements, supervisory staff qualifications, and the need 
for routine survey activities.


Risks:


Less oversight reduces assurance that users are following manufacturers 
instructions and producing reliable results. Technology may not perform 
as reliably as expected in all workplace settings. Test systems may not 
perform as expected in different users' hands. Specimen procurement and 
handling may affect the reliability of testing. We expect no clinically 
meaningful change in test accuracy, or patient health, from this 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 47982                                    00/00/00
NPRM Comment Period End                                        11/14/95
Final Action                                                   00/00/00
Small Entities Affected:


None


Government Levels Affected:


None


Agency Contact:
Anthony Tirone
Director
Division of Survey and Certification
Department of Health and Human Services
Health Care Financing Administration
S-2-19-26
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786-6810
RIN: 0938-AG98
_______________________________________________________________________
HHS--HCFA
41. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HSQ-225-P)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 263a


CFR Citation:


 42 CFR 493.2; 42 CFR 493.7; 42 CFR 493.9; 42 CFR 493.15; 42 CFR 
493.20; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 493.37; 42 CFR 493.39; 42 
CFR 493.45; 42 CFR 493.47; 42 CFR 493.49; 42 CFR 493.53; 42 CFR 
493.1775


Legal Deadline:


None


Abstract:


This rule would revise our current process of evaluating tests against 
generic criteria. A waiver would be granted to any test that meets the 
statutory criteria, provided that scientifically valid data were 
submitted verifying that the criteria were met.


Statement of Need:


This proposed regulation would clarify and expand the waiver criteria 
and streamline the waiver process so that more tests may be categorized 
as waived; that is, free from CLIA performance and personnel 
requirements. CLIA requirements would also be waived for tests approved 
for home use by the Food and Drug Administration.


Summary of the Legal Basis:


The Clinical Laboratory Improvement Advisory Committee (CLIAC) was 
established to advise and make recommendations on technical and 
scientific aspects of the regulations. The CLIAC recommended that the 
criteria for categorizing tests as waived be better defined. As a 
result of the comments concerning waived tests and the CLIAC 
recommendations, the Centers for Disease Control and Prevention 
developed criteria for placing tests in the waived category as outlined 
in this proposal.


Alternatives:


Performance standards based on current analysis specific criteria would 
have limited technology and impeded innovative ideas.


Anticipated Costs and Benefits:


This regulation decreases burden, especially for physician office 
laboratories due to virtually no regulatory oversight. It increases 
access to a greater variety of tests. Physician office laboratories may 
expand the range of tests they perform without an increase in costs/
burden. The regulation creates incentives for manufacturers to develop 
more test systems that meet the clarified waiver criteria and criteria 
for approval for home use. It eliminates inspection fees for many of 
the 60,000 physician offices and other small laboratories performing 
tests that will fall into the expanded waived category.


Risks:


The proposed expansion of the waived criteria and development of a 
process protocol would provide for consistent application of detailed 
standards in order to ensure that tests categorized as waived preclude 
any reasonable risk of harm to patient as a result of testing error.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 47534                                    09/13/95
NPRM Comment Per60 FR 47534                                    11/13/95
Final Action                                                   00/00/00
Small Entities Affected:


None


Government Levels Affected:


None


Agency Contact:
Anthony Tirone
Director
Division of Survey and Certification
Department of Health and Human Services
Health Care Financing Administration
S-2-19-26
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786-6810
RIN: 0938-AG99
_______________________________________________________________________
HHS--HCFA
42.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND FISCAL YEAR 1997 RATES (BPD-847-P)
Priority:


Other Significant


Legal Authority:


 42 USC 1395ww


CFR Citation:


 42 CFR 412; 42 CFR 413


Legal Deadline:


 NPRM, Statutory, May 1, 1996. Final, Statutory, September 1, 1996.


Abstract:


Medicare pays for hospital inpatient services under a prospective 
payment system (PPS) in which payment is made at a predetermined 
specific rate for the operating and capital-related costs associated 
with each discharge. These rules will announce the prospective payment 
rates for operating and capital-related costs for FY 1997. We will also 
revise the Medicare hospital inpatient prospective payment systems for 
operating costs and capital-related costs to implement necessary 
changes arising from our continuing experience with the system. In 
addition, we will set forth rate-of-increase limits as well as policy 
changes for hospitals and hospital units excluded from the prospective 
payment systems. These changes are applicable to discharges occurring 
on or after October 1, 1996.


Statement of Need:


Section 1886(e)(5) of the Social Security Act requires the Secretary to 
publish a proposed notice of prospective payment system policies and 
payment rates in the Federal Register by May 1 and a final rule by 
September 1.


Summary of the Legal Basis:


As noted above, publication of proposed and final rules concerning 
hospital PPS policies and payment rates is required by law. The statute 
sets forth several specific requirements concerning what must be 
included in the PPS proposed and final rules. (See sections 
1886(b)(3)(B), 1886(d)(1)(A), 1886(d)(2)(H), 1886(d)(3)(A), 
1886(d)(3)(E), 1886(d)(4)(C), 1886(e)(4), 1886(e)(5), and 1886(g)(1)(A) 
of the Act.)


Alternatives:


Publication of these rules is not discretionary. Thus, no alternatives 
exist.


Anticipated Costs and Benefits:


We are unable to estimate at this time the costs and benefits 
associated with these rules.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/96
Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


State, Federal


Agency Contact:
Charles Booth
Director, Office of Hospital Policy
Department of Health and Human Services
Health Care Financing Administration
Bureau of Policy Development
C5-02-23
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4487
RIN: 0938-AH34
_______________________________________________________________________
HHS--HCFA

                              -----------

                            FINAL RULE STAGE

                              -----------

43. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS IMPLEMENTING THE 
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA '88) (HSQ-226-
F)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 263a


CFR Citation:


 42 CFR 493


Legal Deadline:


None


Abstract:


Historically the Department regulated by ``location,'' rather than by 
the types of tests they performed. CLIA changes this approach. CLIA 
requires that the Department ``regulated by test,'' using what is 
commonly referred to as the ``complexity model.'' A final rule with 
comment period was published February 28, 1992, that set forth 
standards for all laboratories, based on complexity, and responded to 
public comments on the proposed standards. The regulation was revised 
by rules with comment period published on January 19, 1993, December 6, 
1994, and April 24, 1995. A final rule, which will respond to these 
public comments, will be issued.


Statement of Need:


On October 31, 1988, the Congress enacted comprehensive changes to 
existing laboratory regulations in CLIA. This statute requires the 
regulation of any facility (including physician offices) that performs 
tests on human beings for the purpose of providing information for the 
diagnosis, prevention, or treatment of any disease or impairment of, or 
the assessment of the health of, human beings. Historically, the 
Department had regulated laboratories by ``location,'' rather than by 
the types of tests they performed. CLIA requires that the Department 
regulate by test, using what is commonly referred to as the 
``complexity model'' to categorize individual laboratory tests based on 
the experience, skills, and judgment required to perform each test 
accurately. Requirements vary as a function of the complexity of the 
tests the laboratory conducts.
The law requires the Secretary to implement the numerous provisions 
through regulation to ensure the quality of laboratory testing, 
regardless of where it is provided or who is providing the testing. The 
law also requires the CLIA program be operated through the assessment 
of user fees paid by entities subject to these requirements.
On May 21, 1990, the Department published proposed rules to implement 
CLIA and received public comments from over 60,000 commenters. Based on 
any analysis of these comments, the Public Health Service (PHS) with 
the Health Care Financing Administration (HCFA) developed a final rule 
with comment period that set forth standards for all entities 
performing laboratory testing based on test complexity. This rule was 
published on February 28, 1992, and was effective September 1, 1992. 
This regulation was revised by regulations with comment period 
published on January 19, 1993, December 6, 1994, and April 24, 1995.
Issues that will be addressed in this rule include quality control, 
quality assurance, personnel standards, cytology requirements; 
proficiency testing (PT) requirements; employee workplace drug testing; 
and other issues raised by commenters and experience with 
implementation.
With respect to PT requirements, it is important to note that the July 
1995 report of the President and Vice President on Reinventing Health 
Care Regulations indicated that we will use PT ``failures'' for 
education and as an outcome indicator in laboratory quality. (PT is 
testing samples of known values to assess the accuracy of a 
laboratory's results.) Sanctions (for example, loss of Medicare payment 
or loss of approval to do testing) are imposed only in cases of 
immediate jeopardy or when the laboratory has refused to correct the 
problem or has had repeated failures on PT. This final rule with 
comment period will provide clarification on this issue.
The Clinical Laboratory Improvement Advisory Committee (CLIAC), which 
is composed of members of professional organizations and private 
citizens, is actively involved in making recommendations regarding 
technical and scientific aspects of the regulations. In addition, we 
actively solicit comments from outside organizations such as the 
American Medical Association, the Association of State and Territorial 
Public Health Laboratory Directors, and other professional and medical 
organizations regarding the interpretive guidelines for surveyors.


Summary of the Legal Basis:


This rule summarizes and responds to CLIAC recommendations and public 
comments to four previously published CLIA regulations.


Alternatives:


HHS is currently developing a final rule that will address comments 
received on the final rule with comment period published February 28, 
1992, and further comments received in response to the January 19, 
1993, December 6, 1994, and April 24, 1995 notices with comment period. 
Based on these comments, modifications to improve the cost-
effectiveness of the CLIA standards are under consideration.


Anticipated Costs and Benefits:


It is not possible to project costs and benefits of the omnibus rule at 
this time. These regulations serve to ensure consistent, reliable 
laboratory testing which is an integral part of ensuring that 
individuals receive appropriate treatment.


Risks:


Inferior and inappropriate laboratory testing can result in 
misdiagnosis causing patient harm. CLIA reduces the potential for 
inaccurate diagnosis resulting from poorly performed laboratory testing 
since entities must meet requirements (e.g., quality assurance, 
proficiency testing, quality control, personnel requirements) which 
have a direct impact on laboratory testing results. Overly stringent 
standards could, however, discourage needed testing and reduce early 
detection of health problems. The Department does not at this time have 
an estimate of the magnitude and severity of these types of risks, but 
believes that both the original regulations and the revisions will on 
balance contribute to better diagnosis.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            55 FR 20896                                    05/21/90
NPRM Comment Per55 FR 34289                                    09/21/90
Final Rule With 57 FR 7002riod                                 02/28/92
Comment Period End                                             04/28/92
Effective Date                                                 09/01/92
Effective Date  58 FR 5215                                     01/19/93
Final Rule With 58 FR 5215riod                                 01/19/93
Comment Period E58 FR 6215                                     03/22/93
Final Action                                                   06/00/96
Small Entities Affected:


Businesses


Government Levels Affected:


State, Federal


Agency Contact:
Anthony J. Tirone
Director, Office of Survey and Certification, HSQB
Department of Health and Human Services
Health Care Financing Administration
S-2-19-26
7500 Security Boulevard
Baltimore, MD. 21244
Phone: 410 786-6763
RIN: 0938-AE47
_______________________________________________________________________
HHS--HCFA
44. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION (BPD-745-
P)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 1395(hh)


CFR Citation:


 42 CFR 482


Legal Deadline:


None


Abstract:


This proposed rule would revise the requirements that hospitals must 
meet to participate in the Medicare and Medicaid programs. The revised 
requirements focus on patient care and the outcomes of that care, 
reflect a cross-functional view of patient treatment, encourage 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements. These changes are necessary to reflect 
advances in health care practices since the requirements were last 
revised in 1986. This regulation is part of the Administration's 
Reinventing Government and regulatory reform initiatives.


Statement of Need:


The purpose of the hospital conditions of participation is to protect 
patient health and safety and help assure that quality care is 
furnished to all hospital patients. Hospitals must meet the conditions 
of participation in order to participate in Medicare or Medicaid. 
Revised conditions are necessary to ensure that our regulations focus 
primarily on the actual quality of care furnished to patients, and the 
outcomes of that care, rather than on procedural compliance. These 
changes are intended to give hospitals the flexibility needed to 
achieve high-quality outcomes in the most cost-effective manner.
In addition, the regulations are intended to promote a cross-
functional, interdisciplinary approach to hospital performance, instead 
of an approach geared towards evaluating each department of a hospital 
as a stand-alone entity. This approach is in line with current best 
practices in hospitals, in which patients routinely encounter many 
caregivers and services that often cut across department lines.


Summary of the Legal Basis:


Section 1961(e) of the Social Security Act (the Act) provides that a 
hospital participating in the Medicare program must meet certain 
specified requirements. In addition, section 19861(e)(9) of the Act 
specifies that a hospital also must meet such requirements that the 
Secretary finds are necessary in the interest of the health and safety 
of the hospital's patients. Under this authority, the Secretary has 
established in regulations the requirements that a hospital must meet 
to participate in Medicare. These requirements are set forth in 
regulations at 42 CFR Part 482, Conditions of Participation for 
Hospitals. Section 1905(a) of the Act provides that Medicaid payments 
may be applied to hospital services. Under regulations at 42 CFR 
440.10(a)(3)(iii), hospitals generally are required to meet the 
Medicare conditions of participation in order to participate in 
Medicaid.


Alternatives:


HCFA considered the possibility of revising individual sections of the 
current hospital regulations. However, we determined that the best 
means of achieving the systematic changes needed in the regulations was 
to revise the hospital conditions in their entirety. The specific areas 
that are likely to form the core of the revised requirements include 
patient rights, patient assessment, patient care, quality assessment 
and improvement, and information management.


Anticipated Costs and Benefits:


There would not be significant costs associated with this proposed 
rule. The benefits that would be derived from the rule are discussed in 
the Need section, above.


Risks:


By revising these regulations to focus on the quality of the actual 
care given to an individual and the effectiveness of that care for the 
individual patient, we hope to reduce risks to beneficiaries' health 
and safety. Revised procedures can better focus on ensuring that the 
care being given to a patient is the care that is actually necessary 
and effective for that patient. No quantitative estimates of risk 
reductions are available yet.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM Comment Per60 FR 48417                                    08/19/95
Final Action Effective                                         11/01/95
NPRM                                                           01/00/96
Final Action                                                   09/00/96
Small Entities Affected:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Charles Booth
Director, Office of Hospital Policy
Department of Health and Human Services
Health Care Financing Administration
C5-02-23
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-1850
RIN: 0938-AG79
_______________________________________________________________________
HHS--HCFA
45. MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND ADJUSTMENTS TO 
THE RELATIVE VALUE UNITS (RVUS) UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 1996 (BPD-827-FC)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 1395w-4


CFR Citation:


 42 CFR 400; 42 CFR 405; 42 CFR 410; 42 CFR 411; 42 CFR 412; 42 CFR 
413; 42 CFR 414; 42 CFR 415; 42 CFR 417; 42 CFR 489


Legal Deadline:


 Final, Statutory, January 1, 1996.


Abstract:


This final rule with comment period revises various payment policies 
for specific physician services and the relative value units (RVUs) for 
certain existing procedure codes, effective January 1, 1996. It also 
establishes interim RVUs for new and revised procedure codes. The rule 
implements section 1848 of the Social Security Act.


Statement of Need:


The Omnibus Budget Reconciliation Act (OBRA) of 1989 changed the basis 
of the Medicare Physician payment system from reasonable charge to a 
fee schedule based on relative value units (RVUs). The fee schedule was 
first implemented in 1992. This document will announce the RVUs upon 
which Medicare payment for physician services will be based in 1996, 
including interim RVUs for procedure codes that are new or revised for 
1996. The public was given a 60-day period to comment on the interim 
values. It will also explain the process by which the interim RVUs were 
reviewed and, in some cases, revised as a result of public comments.
After 3 full years of experience with the physician fee schedule, we 
have reevaluated several payment policies related to it. Proposed 
revisions to these policies were announced in a notice of proposed 
rulemaking on July 26, 1995. This final rule will respond to the public 
comments received on those proposals and announces the final policy 
decisions. Thus, it will discuss changes in payment for the services of 
teaching physicians, limiting payment for interpretation of 
electrocardiograms and x-rays taken in the emergency room, making 
budget neutrality adjustments on the conversion factor rather than the 
RVUs, and changes in the calculation of the multiple volume performance 
standard (MVPS). It will also announce final decisions regarding the 
extension of the site-of-service payment differential to ambulatory 
surgical centers, prohibition of separate payment for the 
transportation of diagnostic equipment to a patient, expansion of the 
definition of ``diagnostic'' mammography, and a variety of bundled 
services.
This document also discusses the process for periodic review and 
adjustment of all RVUs. In this regard, we have and will continue to 
work with the physician community through the American Medical 
Association Specialty Society Relative Value Update Committee.


Alternatives:


An alternative to this notice would be to continue to base payments on 
1995 RVUs. This would continue inappropriate payments for certain 
services and would not allow a national basis for paying for new 
services. By not revising the payment policies described in this 
notice, we would continue inadequate or inequitable payments for 
certain physician services.


Anticipated Costs and Benefits:


Section 1848(c)(2)(B) of the Social Security Act requires that 
adjustments to RVUs for a year may not cause the amount of expenditures 
to differ by more than $20 million from the amount of expenditures if 
the adjustments had not been made. In general, the payment policies and 
other revisions included in this notice will be implemented in a 
budget-neutral manner. Thus, total Medicare expenditures will not be 
increased or decreased as a result of most of these changes.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 38400                                    07/26/95
Final Rule With Comment Period                                 12/00/95
Small Entities Affected:


None


Government Levels Affected:


None


Agency Contact:
Terrence Kay
Director, Division of Physician Services
Office of Physician & Ambulatory Care Policy
Department of Health and Human Services
Health Care Financing Administration
C4-10-26
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786-4497
RIN: 0938-AG96
_______________________________________________________________________
HHS--HCFA
46.  CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO CERTAIN 
DEVICES AND RELATED SERVICES (BPD-841-FC)
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 1395y(a)(1)(A)


CFR Citation:


 42 CFR 405; 42 CFR 411


Legal Deadline:


None


Abstract:


This final rule establishes in regulations that certain medical devices 
with an investigational device exemption (IDE) approved by the Food and 
Drug Administration (FDA) may be covered under Medicare. Specifically, 
it sets forth the process by which the FDA will assist HCFA in 
identifying nonexperimental investigational devices that may be 
potentially covered under Medicare. It is intended to provide Medicare 
beneficiaries with greater access to advances in medical technology.


Statement of Need:


In his National Performance Review, Vice President Gore directed the 
health agencies of the Department of Health and Human Services (HHS) to 
review their policies and processes to determine which requirements 
could be reduced or eliminated without lowering health and safety 
standards. In accordance with this directive, FDA reviewed its current 
regulatory approval processes and HCFA reviewed its Medicare coverage 
policies for medical devices that have not received full FDA approval.
The Medicare program has historically interpreted the statutory terms 
``reasonable and necessary'' to mean that a service or medical device 
must be safe and effective, medically necessary and appropriate, and 
not experimental, in order to qualify for reimbursement. For Medicare 
coverage proposes, the term experimental has been used synonymously 
with the term investigational. Therefore, an approved investigational 
device exemption (IDE) application served as an indication that the 
device was not ``reasonable and necessary'' within the meaning of the 
Medicare program. Under this policy, Medicare coverage was denied for 
devices that require, but have yet to receive, 510(k) clearance and 
those that have received an IDE but have not received premarket 
approval (PMA).
There is increasing recognition that there are devices which are 
refinements of existing technologies or replications of existing 
technologies by other manufacturers. Many of these devices are placed 
within the IDE category as a means of gathering the scientific 
information necessary for FDA to establish the safety and effectiveness 
of the particular device, even though there is scientific evidence that 
the type of device can be safe and effective. Arguably, these devices 
could be viewed as ``reasonable and necessary'' by Medicare and 
recognized for payment if it were possible to identify them in the 
FDA's process.
Accordingly, FDA and HCFA are developing a revised policy to meet the 
needs of Medicare beneficiaries. The purpose of this effort is to 
determine if it is feasible to expand Medicare coverage to include 
certain medical devices that have not yet received FDA marketing 
approval/clearance without compromising the safety of medical care 
provided to Medicare beneficiaries. The intent is to devise ways to 
assure Medicare beneficiaries greater access to advances in proven 
medical technology, to encourage clinical researchers to conduct high-
quality studies, and to clarify Medicare coverage of reasonable and 
necessary medical services during clinical trials for investigational 
devices.


Anticipated Costs and Benefits:


In most instances, payment for devices covered as a result of this 
regulation will be held to the level of the most similar approved 
device. However, it is possible that some beneficiaries may be better 
suited to the newly covered device, resulting in some additional 
claims. Program costs associated with any new claims are estimated at 
$7 million for fiscal year 1996, rising to $9 million in fiscal year 
2000.


Risks:


The anticipated policy will make more effective medical devices 
available sooner without exosing clients to additional risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Rule With 60 FR 48417iod                                 08/19/95
Comment Period End                                             10/20/95
Effective Date                                                 11/01/95
Final Action                                                   09/00/96
Small Entities Affected:


None


Government Levels Affected:


None


Agency Contact:
Sharon Hippler
Bureau of Policy Development
Department of Health and Human Services
Health Care Financing Administration
C4-11-04
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4633
RIN: 0938-AH21
_______________________________________________________________________
HHS--Administration for Children and Families (ACF)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

47. QUALITY STANDARDS FOR HEAD START PROGRAMS
Priority:


Other Significant


Reinventing Government:


This rulemaking is part of the Reinventing Government effort. It will 
revise text in the CFR to reduce burden or duplication, or streamline 
requirements.


Legal Authority:


 42 USC 9801


CFR Citation:


 45 CFR 1301; 45 CFR 1304; 45 CFR 1309


Legal Deadline:


 NPRM, Statutory, May 18, 1995.


Legal deadline only pertains to performance standards.


Abstract:


The NPRM will establish performance standards with respect to services 
provided to children 0 to 5 years old by Head Start Programs, including 
health, education, parent involvement, nutritional, social, and 
transitional services, administrative and financial management 
standards and standards relating to the condition and location of 
facilities used to carry out Head Start activities.


Statement of Need:


This regulation responds to the Administration's commitment to re-
engineer the Head Start program in terms of quality improvement and 
capacity expansion and incorporates the Head Start Amendments of 1994 
provision authorizing a new program of comprehensive, developmental 
services for low-income families with infants and toddlers. The statute 
requires the Department of Health and Human Services to publish 
performance standards governing the projects to be funded under this 
authority.


Summary of the Legal Basis:


Section 112, Title I (the Head Start Act Amendments of 1994) of the 
Human Resource Amendments of 1994.


Alternatives:


These rules are required by statutory mandate. To the extent that there 
is flexibility in regulating specific provisions, all reasonable 
alternatives were considered by the Administration for Children, Youth 
and Families prior to the promulgation.


Anticipated Costs and Benefits:


Any costs associated with this regulation are the result of legislation 
and therefore are reflected in the President's budget.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/95
Small Entities Affected:


Governmental Jurisdictions, Organizations


Government Levels Affected:


Local, Tribal


Agency Contact:
Douglas Klafehn
Deputy Associate Commissioner
Head Start Bureau
Department of Health and Human Services
Administration for Children and Families
P.O. Box 1182
Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB55
BILLING CODE 4150-04-F