Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 64201 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Statement of Regulatory Priorities 

The Department of Health and Human 

Services (HHS) is the Federal 

Government’s principal agency charged 

with protecting the health of all 

Americans and providing essential 

human services. HHS responsibilities 

include: Medicare, Medicaid, support 

for public health preparedness and 

emergency response, biomedical 

research, substance abuse and mental 

health treatment and prevention, 

assurance of safe and effective drugs 

and other medical products, protection 

of our Nation’s food supply, assistance 

to low income families, the Head Start 

program, services to older Americans, 

and direct health services delivery. 

These programs constitute a 

substantial portion of the priorities of 

the federal government, and, as such, 

the HHS budget represents almost a 

quarter of all federal outlays, and the 

Department administers more grant 

dollars than all other agencies 

combined. 

Since assuming the leadership of HHS 

this year, Secretary Kathleen G. Sebelius 

has sought to prioritize efforts to 

prepare the country for H1N1 influenza, 

enhance security of the nation’s food 

supply, implement regulation of 

tobacco, stop the spread of HIV/AIDS 

and ensure that those affected get the 

care and support they need, and 

successfully build the country’s 

healthcare infrastructure through 

distribution of $167 billion in funding 

from the American Recovery and 

Reinvestment Act of 2009. Further, the 

Secretary has worked closely with the 

President on the Administration’s 

efforts to enact meaningful reform of the 

country’s health care system, and the 

Department will focus considerable 

effort on implementation of health care 

reform once passed by the Congress. 

The Department’s regulatory priorities 

in the upcoming fiscal year reflect the 

above goals, and include: 

Tobacco Regulation 

Each year in the United States, over 

440,000 people die as a result of 

cigarette smoking. This represents one 

in every five deaths in adults. Reducing 

our nation’s tobacco use will save lives, 

reduce health care costs, and help 

reduce suffering from heart and lung 

diseases, cancer, and other tobaccorelated illnesses. As directed by the 

Family Smoking Prevention and 

Tobacco Control Act, the Secretary 

would re-establish the bulk of the 

provisions of the August 1996 final rule 

restricting access to and promotion of 

tobacco products to minors when many 

adult smokers begin their tobacco use 

habits. 

Food Safety 

The Department is committed to 

making dramatic improvements in our 

food safety system. These efforts are 

guided in part by the recent findings of 

the President’s Food Safety Working 

Group which adopted a public-health 

approach based on three core principles: 

prioritizing prevention, strengthening 

surveillance and enforcement, and 

improving response and recovery if 

prevention fails. The goal of this new 

agenda is to shift emphasis away from 

mitigating public health harm by 

removing unsafe products from the 

market place, to a new overriding 

objective — preventing harm by keeping 

unsafe food from entering commerce in 

the first place. Progress has already 

begun on this new strategy. One 

example is the recent egg safety rule, 

which requires science-based measures 

to prevent Salmonella Enteritidis 

contamination of shell eggs at the farm, 

as well as safe handling temperature 

controls throughout the distribution 

chain. We intend to continue this focus 

on prevention with upcoming rules on 

produce safety and Good Manufacturing 

Practices modernization. The 

Department also looks forward to 

continuing work with the Congress to 

transform our nation’s approach to food 

safety and strengthen our ability to 

prevent foodborne illness. 

Mental Health Parity 

Congress passed and the President 

signed legislation in October of 2008 

that was a major step forward in 

improving access to mental health and 

substance abuse services for those who 

need them by requiring that all financial 

requirements and treatment limitations 

applicable to mental health and 

substance use disorders are no more 

restrictive than those requirements and 

limitations placed on physical benefits. 

Critical to the implementation of the 

law is the issuance of regulations to 

help employers and insurers understand 

what is required of them. The Secretary 

has directed the Centers for Medicare & 

Medicaid Services (CMS) to work with 

the Departments of Treasury and Labor 

to craft these regulations so as to guide 

employers and insurers on how to 

implement this statute and meet the 

important goal of furthering the 

integration of mental health and 

substance abuse services into primary 

health care. 

Medicare Modernization 

The Regulatory Plan highlights three 

final rules that would adjust payment 

amounts under Medicare for physicians’ 

services, hospital inpatient and hospital 

outpatient services for fiscal year 2011. 

These new payment rules reflect 

continuing experience with regulating 

these systems, and will implement 

modernizations to ensure that the 

Medicare program best serves its 

beneficiaries, fairly compensates 

providers, and remains fiscally sound. 

Healthcare Information Technology 

Broad use of electronic health records 

has the potential to improve health care 

quality, prevent medical errors, increase 

the efficiency of care provision and 

reduce unnecessary health care costs, 

increase administrative efficiencies, 

decrease paperwork, and improve 

population health. Towards achieving 

these benefits, the Department will 

promulgate a proposed rule that would 

provide financial incentives to certain 

providers that meaningfully implement 

electronic health records, and an 

interim final rule that sets standards for 

such records that will enhance their 

interoperability, functionality, and 

utility. 

Additionally, the Department will 

issue a proposed rule to implement 

privacy provisions of the Health 

Information Technology for Economic 

and Clinical Health (HITECH) Act that 

will strengthen privacy and security 

protections that govern how health 

information is used and disclosed in the 

face of the modernization of health 

recordkeeping. 

Streamlining Drug & Device 

Requirements 

Three Food and Drug Administration 

(FDA) proposed rules would 

standardize the electronic submission of 

clinical study data, medical device 

registrations, and adverse event reports. 

These rules will enable the FDA to more 

quickly and efficiently process and 

review information submitted, 

furthering their ability to both better 

protect the public safety and more 

rapidly advance new innovations to the 

market. 


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64202 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 

HHS—Office of the Secretary (OS) 

PROPOSED RULE STAGE 

42. STANDARDS FOR PRIVACY OF 

INDIVIDUALLY IDENTIFIABLE HEALTH 

INFORMATION; MODIFICATIONS TO 

THE HIPAA PRIVACY RULE UNDER 

THE HEALTH INFORMATION 

TECHNOLOGY FOR ECONOMIC AND 

CLINICAL HEALTH ACT 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

PL 111–5, secs 13400 to 13410 

CFR Citation: 

45 CFR 160; 45 CFR 164 

Legal Deadline: 

NPRM, Statutory, February 17, 2010. 

Abstract: 

The Department of Health and Human 

Services Office for Civil Rights will 

issue rules to modify the HIPAA 

Privacy Rule as necessary to implement 

the accounting provisions of Section 

13405(c) of the Health Information 

Technology for Economic and Clinical 

Health Act (Title XIII of the American 

Recovery and Reinvestment Act of 

2009). 

Statement of Need: 

The Office for Civil Rights will issue 

rules to modify the HIPAA Privacy rule 

to implement the privacy provisions in 

sections 13400-13410 of the Health 

Information technology for economic 

and clinical health Act (Title XIII of 

division a of the American Recovery 

and Reinvestment Act of 2009, Pub. L. 

111-5). these regulations will improve 

the privacy and security protection of 

health information. 

Summary of Legal Basis: 

Subtitle D of the Health Information 

Technology for Economic and Clinical 

Health Act (Title XIII of the American 

Recovery and Reinvestment Act of 

2009) requires the Office for Civil 

Rights to modify certain provisions of 

the HIPAA Privacy and Security Rules 

to implement sections 13400-13410 of 

the Act. 

Alternatives: 

The Office for Civil Rights is statutorily 

mandated to make modifications to the 

HIPAA Privacy and Security Rules to 

implement the privacy provisions at 

sections 13400-13410 of the Health 

Information Technology for Economic 

and Clinical Health Act (Title XIII of 

the American Recovery and 

Reinvestment Act of 2009). 

Anticipated Cost and Benefits: 

These modifications to the HIPAA 

Privacy Rule are intended to benefit 

health care consumers by strengthening 

the privacy and security protections 

that govern how their health 

information is used and disclosed by 

HIPAA covered entities and their 

business associates. The Agency 

believes that there may be costs 

associated with the regulations that will 

affect HIPAA covered entities and their 

business associates. These may include 

costs to redraft existing business 

associate contracts as well as for the 

training on new policies and 

procedures as a result of these 

regulations. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/09 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

State 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Andra Wicks 

Department of Health and Human 

Services 

200 Independence Avenue SW. 

Washington, DC 20201 

Phone: 202 205–2292 

Fax: 202 205–4786 

Email: andra.wicks@hhs.gov 

RIN: 0991–AB57 

HHS—OS 

FINAL RULE STAGE 

43. ∑ HEALTH INFORMATION 

TECHNOLOGY: INITIAL SET OF 

STANDARDS, IMPLEMENTATION 

SPECIFICATIONS, AND 

CERTIFICATION CRITERIA FOR 

ELECTRONIC HEALTH RECORD 

TECHNOLOGY (RULEMAKING 

RESULTING FROM A SECTION 610 

REVIEW) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 300jj–14 

CFR Citation: 

45 CFR 170 

Legal Deadline: 

Other, Statutory, December 31, 2009, 

Interim final rule. 

Abstract: 

The Department of Health and Human 

Services (HHS), Office of the National 

Coordinator for Health Information 

Technology, will issue an interim final 

rule with a request for comments to 

adopt an initial set of standards, 

implementation specifications, and 

certification criteria, as required by 

section 3004(b)(1) of the Public Health 

Service Act. 

Statement of Need: 

This interim final rule represents the 

first round of what will be an 

incremental approach to adopting 

standards, implementation 

specifications, and certification criteria 

for health information technology. The 

certification criteria adopted in this 

initial set establish the technical 

capabilities and related standards that 

certified electronic health record (EHR) 

technology will need to include in 

support of the Medicare and Medicaid 

EHR Incentive Programs. 

Summary of Legal Basis: 

Section 3004(b)(1) of the PHSA requires 

the Secretary to adopt an initial set of 

standards, implementation 

specifications, and certification criteria 

by 12/31/09. This interim final rule is 

being published to meet this 

requirement. 

Alternatives: 

No alternatives are available because 

the issuance of this regulation is 

required by statute. 


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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 64203 

Anticipated Cost and Benefits: 

We anticipate that there will be costs 

incurred as a result of the interim final 

rule to prepare health information 

technology for certification. 

Benefits include improved 

interoperability and increased health 

information technology adoption. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 12/00/09 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal 

Agency Contact: 

Steven Posnack 

Policy Analyst 

Department of Health and Human 

Services 

Office of the Secretary 

Office of the National Coordinator for 

Health Information Technology 

200 Independence Avenue SW 

Washington, DC 20201 

Phone: 202 690–7151 

RIN: 0991–AB58 

HHS—Food and Drug Administration 

(FDA) 

PROPOSED RULE STAGE 

44. ELECTRONIC SUBMISSION OF 

DATA FROM STUDIES EVALUATING 

HUMAN DRUGS AND BIOLOGICS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

21 USC 355; 21 USC 371; 42 USC 262 

CFR Citation: 

21 CFR 314.50; 21 CFR 601.12; 21 CFR 

314.94; 21 CFR 314.96 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration is 

proposing to amend the regulations 

governing the format in which clinical 

study data and bioequivalence data are 

required to be submitted for new drug 

applications (NDAs), biological license 

applications (BLAs), and abbreviated 

new drug applications (ANDAs). The 

proposal would revise our regulations 

to require that data submitted for 

NDAs, BLAs, and ANDAs, and their 

supplements and amendments, be 

provided in an electronic format that 

FDA can process, review, and archive. 

Statement of Need: 

Before a drug is approved for 

marketing, FDA must determine that 

the drug is safe and effective for its 

intended use. This determination is 

based in part on clinical study data and 

bioequivalence data that are submitted 

as part of the marketing application. 

Study data submitted to FDA in 

electronic format have generally been 

more efficient to process and review. 

FDA’s proposed rule would require the 

submission of study data in a 

standardized electronic format. 

Electronic submission of study data 

would improve patient safety and 

enhance health care delivery by 

enabling FDA to process, review, and 

archive data more efficiently. 

Standardization would also enhance 

the ability to share study data and 

communicate results. Investigators and 

industry would benefit from the use of 

standards throughout the lifecycle of a 

study—in data collection, reporting, 

and analysis. The proposal would work 

in concert with ongoing agency and 

national initiatives to support increased 

use of electronic technology as a means 

to improve patient safety and enhance 

health care delivery. 

Summary of Legal Basis: 

Our legal authority to amend our 

regulations governing the submission 

and format of clinical study data and 

bioequivalence data for human drugs 

and biologics derives from sections 505 

and 701 of the Act (U.S.C. 355 and 371) 

and section 351 of the Public Health 

Service Act (42 U.S.C. 262). 

Alternatives: 

FDA considered issuing a guidance 

document outlining the electronic 

submission and the standardization of 

study data, but not requiring electronic 

submission of the data in the 

standardized format. This alternative 

was rejected because the agency would 

not fully benefit from standardization 

until it became the industry standard, 

which could take up to 20 years. 

We also considered a number of 

different implementation scenarios, 

from shorter to longer time-periods. 

The 2-year time-period was selected 

because the agency believes it would 

provide ample time for applicants to 

comply without too long a delay in the 

effective date. A longer time-period 

would delay the benefit from the 

increased efficiencies, such as 

standardization of review tools across 

applications, and the incremental cost 

savings to industry would be small. 

Anticipated Cost and Benefits: 

Standardization of clinical data 

structure, terminology, and code sets 

will increase the efficiency of the 

agency review process. FDA estimates 

that the costs to industry resulting from 

the proposal would include some onetime costs and possibly some annual 

recurring costs. One-time costs would 

include, among other things, the cost 

of converting data to standard 

structures, terminology, and cost sets 

(i.e., purchase of software to convert 

data); the cost of submitting electronic 

data (i.e., purchase of file transfer 

programs); and the cost of installing 

and validating the software and training 

personnel. Additional annual recurring 

costs may result from software 

purchases and licensing agreements for 

use of proprietary terminologies. 

The proposal could result in many 

long-term benefits for industry, 

including improved patient safety 

through faster, more efficient, 

comprehensive, and accurate data 

review, as well as enhanced 

communication among sponsors and 

clinicians. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 


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64204 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 

Agency Contact: 

Martha Nguyen 

Regulatory Counsel 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Drug Evaluation and Research 

10903 New Hampshire Avenue 

Bldg. 51, Room 6224 

Silver Spring, MD 20993–0002 

Phone: 301 796–3471 

Fax: 301 847–8440 

Email: martha.nguyen@fda.hhs.gov 

RIN: 0910–AC52 

HHS—FDA 

45. ELECTRONIC REGISTRATION AND 

LISTING FOR DEVICES 

Priority: 

Other Significant 

Legal Authority: 

PL 110–85; PL 107–188, sec 321; PL 

107–250, sec 207; 21 USC 360(a) 

through 360(j); 21 USC 360(p) 

CFR Citation: 

21 CFR 807 

Legal Deadline: 

None 

Abstract: 

FDA is proposing to amend the medical 

device establishment registration and 

listing regulations at 21 CFR part 807 

to reflect the electronic submission 

requirements in section 510(p) of the 

Federal Food, Drug, and Cosmetic Act 

(the Act). Section 510(p) was added to 

the Act by section 207 of the Medical 

Device User Fee and Modernization Act 

of 2002 (MDUFMA), and later amended 

in September 2007 by section 224 of 

the Food and Drug Administration 

Amendments Act of 2007 (FDAAA). 

This proposed rule would require 

domestic and foreign device 

establishments to submit registration 

and listing data electronically via the 

Internet using FDA’s Unified 

Registration and Listing System. This 

proposed rule would convert 

registration and listing to a paperless 

process. However, for those companies 

that do not have access to the Web, 

FDA would offer an avenue by which 

they can register, list, and update 

information with a paper submission. 

The proposed rule also would amend 

part 807 to reflect the timeframes for 

device establishment registration and 

listing established by sections 222 and 

223 of FDAAA, and to reflect the 

requirement in section 510(i) of the 

Act, as amended by section 321 of the 

Public Health Security and Bioterrorism 

Preparedness and Response Act (BT 

Act), that foreign establishments 

provide FDA with additional pieces of 

information as part of their registration. 

Statement of Need: 

FDA is proposing to amend the medical 

device establishment registration and 

listing requirements under 21 CFR part 

807 to reflect the electronic submission 

requirements in section 510(p) of the 

Act, which was added by section 207 

of MDUFMA and later amended by 

section 224 of FDAAA. FDA also is 

proposing to amend 21 CFR part 807 

to reflect the requirements in section 

321 of the BT Act for foreign 

establishments to furnish additional 

information as part of their registration. 

This proposed rule would improve 

FDA’s device establishment registration 

and listing system and utilize the latest 

technology in the collection of this 

information. 

Summary of Legal Basis: 

The statutory basis for our authority 

includes sections 510(a) through (j), 

510(p), 701, 801, and 903 of the Act. 

Alternatives: 

The alternatives to this rulemaking 

include not updating the registration 

and listing regulations. Because of the 

new FDAAA statutory requirements, 

and the advances in data collection and 

transmission technology, FDA believes 

this rulemaking is the preferable 

alternative. 

Anticipated Cost and Benefits: 

The Agency believes that there may be 

some one-time costs associated with the 

rulemaking, which involve resource 

costs of familiarizing users with the 

electronic system. Recurring costs 

related to submission of the 

information by domestic firms would 

probably remain the same or decrease 

because a paper submission and 

postage is not required. There might be 

some increase in the financial burden 

on foreign firms since they will have 

to supply additional registration 

information as required by section 321 

of the BT Act. 

Risks: 

None 

Timetable: 

Action Date FR Cite 

NPRM 09/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Myrna Hanna 

Regulations Staff 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Devices and Radiological 

Health 

10903 New Hampshire Avenue 

WO–66 Room 4436 

Silver Spring, MD 20993 

Phone: 301 796–5739 

Fax: 301 847–8144 

Email: myrna.hanna@fda.hhs.gov 

RIN: 0910–AF88 

HHS—FDA 

46. ∑ PRODUCE SAFETY 

REGULATION 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

21 USC 342; 21 USC 371; 42 USC 264 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration is 

proposing to promulgate regulations 

setting enforceable standards for fresh 

produce safety at the farm and packing 

house. The purpose of the proposed 

rule is to reduce the risk of illness 

associated with contaminated fresh 

produce. The proposed rule will be 

based on prevention-oriented public 

health principles and incorporate what 

we have learned in the past decade 

since the agency issued general good 

agricultural practice guidelines entitled 

‘‘Guide to Minimize Microbial Food 

Safety Hazards for Fresh Fruits and 

Vegetables’’ (GAPs Guide). The 

proposed rule also will reflect 

comments received on the agency’s 

1998 update of its GAPs guide and its 

July 2009 draft commodity specific 


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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 64205 

guidances for tomatoes, leafy greens, 

and melons. Although the proposed 

rule will be based on recommendations 

that are included in the GAPs guide, 

it does not make the entire guidance 

mandatory. FDA’s proposed rule 

would, however, set out clear standards 

for implementation of modern 

preventive controls. The proposed rule 

also would emphasize the importance 

of environmental assessments to 

identify hazards and possible pathways 

of contamination and provide examples 

of risk reduction practices recognizing 

that operators must tailor their 

preventive controls to particular 

hazards and conditions affecting their 

operations. The requirements of the 

proposed rule would be scale 

appropriate and commensurate with the 

relative risks and complexity of 

individual operation. FDA intends to 

issue guidance after the proposed rule 

is finalized to assist industry in 

complying with the requirements of the 

new regulation. 

Statement of Need: 

FDA has determined that enforceable 

standards (as opposed to voluntary 

recommendations) for the production 

and packing of fresh produce are 

necessary to ensure best practices are 

commonly adopted. 

Summary of Legal Basis: 

FDA’s legal basis derives in part from 

sections 402(a)(4) and 701(a) of the 

Federal Food, Drug, and Cosmetic Act 

(the Act) (21 U.S.C. 342(a)(4) and 

371(a)). The agency has promulgated 

regulations that respond to a number 

of the provisions of the 1986 

amendments. This final rule would 

address additional provisions of these 

amendments. 

Alternatives: 

An alternative to this rulemaking 

would be to update FDA’s 1998 GAPs 

Guide. However, even though the 1998 

guidance has been well received and 

widely adopted, outbreaks associated 

with fresh produce continue. Outbreak 

investigations also continue to observe 

conditions and practices that are not 

consistent with the voluntary 

recommendations. FDA believes a 

regulation containing clear, enforceable 

standards would be more effective in 

ensuring best practices are widely 

adopted. 

Anticipated Cost and Benefits: 

FDA estimates that the costs to more 

than 300,000 domestic and foreign 

producers and packers of fresh produce 

from the proposal would include onetime costs (e.g., new tools and 

equipment) and recurring costs (e.g., 

monitoring, training, recordkeeping). 

FDA anticipates that the benefits would 

be a reduction in foodborne illness and 

deaths associated with fresh produce. 

Monetized estimates of costs and 

benefits are not available at this time. 

Risks: 

This regulation would directly and 

materially advance the Federal 

Government’s substantial interest in 

reducing the risks for illness and death 

associated with foodborne infections 

resulting from the consumption of 

contaminated fresh produce. Less 

restrictive and less comprehensive 

approaches have not been effective in 

reducing the problems addressed by 

this regulation. FDA anticipates that the 

regulation would lead to a significant 

decrease in foodborne illness associated 

with fresh produce in the U.S. 

Timetable: 

Action Date FR Cite 

NPRM 10/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Federalism: 

Undetermined 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Samir Assar 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition 

Office of Food Safety 

5100 Paint Branch Parkway 

College Park, MD 20740 

Phone: 301 436–1636 

Email: samir.assar@fda.hhs.gov 

RIN: 0910–AG35 

HHS—FDA 

47. ∑ MODERNIZATION OF THE 

CURRENT FOOD GOOD 

MANUFACTURING PRACTICES 

REGULATION 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

21 USC 342; 21 USC 371; 42 USC 264 

CFR Citation: 

21 CFR 110 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration 

(FDA) is proposing to amend its current 

good manufacturing practices (CGMP) 

regulations (21 CFR part 110) for 

manufacturing, packing, or holding 

human food. This proposed rule would 

require food facilities to address issues 

such as environmental pathogens, food 

allergens, mandatory employee training, 

and sanitation of food contact surfaces. 

The proposed rule also would require 

food facilities to develop and 

implement preventive control systems. 

FDA is taking this action to better 

address changes that have occurred in 

the food industry and thereby protect 

public health. 

Statement of Need: 

FDA last updated its food CGMP 

regulations for manufacturing, packing 

or holding of human food in 1986. 

Modernizing these food CGMP 

regulations to more explicitly address 

issues such as environmental 

pathogens, food allergens, mandatory 

employee training, and sanitation of 

food contact surfaces, as well as riskbased preventive controls, would be a 

critical step in raising the standards for 

food production and distribution. By 

amending 21 CFR 110 to modernize 

good manufacturing practices, the 

agency could focus the attention of 

food processors on measures that have 

been proven to significantly reduce the 

risk of food-borne illness. An amended 

regulation also would allow the agency 

to better focus its regulatory efforts on 

ensuring industry compliance with 

controls that have a significant food 

safety impact. 

Summary of Legal Basis: 

FDA’s legal authority to amend its 

CGMP regulations derives in part from 

sections 402(a)(3), (a)(4) and 701(a) of 

the Federal Food, Drug, and Cosmetic 


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64206 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 

Act (the Act) (21 U.S.C. 342(a)(3), (a)(4), 

and 371(a)). Under section 402(a)(3) of 

the Act, a food is adulterated if it 

consists in whole or in part of any 

filthy, putrid, or decomposed 

substance, or if it is otherwise unfit for 

food. Under section 402(a)(4), a food 

is adulterated if it has been prepared, 

packed, or held under insanitary 

conditions whereby it may have 

become contaminated with filth or may 

have been rendered injurious to health. 

Under section 701(a) of the Act, FDA 

is authorized to issue regulations for 

the efficient enforcement of the Act. 

FDA’s legal basis also derives from 

section 361 of the Public Health Service 

Act (PHS Act) (42 U.S.C. 264), which 

gives FDA authority to promulgate 

regulations to control the spread of 

communicable disease. 

Alternatives: 

An alternative to this rulemaking is not 

to update the CGMP regulations, and 

instead to issue guidance on best 

practices regarding environmental 

pathogens, food allergens, mandatory 

employee training, sanitation of food 

contact surfaces, and risk-based 

preventive controls. However, guidance 

is voluntary and unenforceable. FDA 

believes a regulation containing clear, 

enforceable standards would be more 

effective in ensuring protection of 

public health. 

Anticipated Cost and Benefits: 

FDA estimates that the costs from the 

proposal to domestic and foreign 

producers and packers of processed 

foods would include new one-time 

costs (e.g., adoption of written food 

safety plans, setting up training 

programs, implementing allergen 

controls, and purchasing new tools and 

equipment) and recurring costs (e.g., 

auditing and monitoring suppliers of 

sensitive raw materials and ingredients, 

training employees, and completing 

and maintaining records used 

throughout the facility). FDA 

anticipates that the benefits would be 

a reduced risk of foodborne illness and 

deaths from processed foods and from 

a reduction in the number of safety 

related recalls. 

Risks: 

This regulation will directly and 

materially advance the federal 

government’s substantial interest in 

reducing the risks for illness and death 

associated with foodborne infections. 

Less restrictive and less comprehensive 

approaches have not been effective in 

reducing the problems addressed by 

this regulation. The regulation will lead 

to a significant decrease in foodborne 

illness in the U.S. 

Timetable: 

Action Date FR Cite 

NPRM 10/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Federalism: 

Undetermined 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Paul South 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition (HFS–317) 

Office of Food Safety 

5100 Paint Branch Parkway 

College Park, MD 20740 

Phone: 301 436–1640 

Email: paul.south@fda.hhs.gov 

RIN: 0910–AG36 

HHS—FDA 

FINAL RULE STAGE 

48. INFANT FORMULA: CURRENT 

GOOD MANUFACTURING 

PRACTICES; QUALITY CONTROL 

PROCEDURES; NOTIFICATION 

REQUIREMENTS; RECORDS AND 

REPORTS; AND QUALITY FACTORS 

Priority: 

Other Significant 

Legal Authority: 

21 USC 321; 21 USC 350a; 21 USC 371; 

. . . 

CFR Citation: 

21 CFR 106 and 107 

Legal Deadline: 

None 

Abstract: 

The agency published a proposed rule 

on July 9, 1996, that would establish 

current good manufacturing practice 

regulations, quality control procedures, 

quality factors, notification 

requirements, and records and reports 

for the production of infant formula. 

This proposal was issued in response 

to the 1986 Amendments to the Infant 

Formula Act of 1980. On April 28, 

2003, FDA reopened the comment 

period to update comments on the 

proposal. The comment period was 

extended on June 27, 2003, to end on 

August 26, 2003. The comment period 

was reopened on August 1, 2006, to 

end on September 15, 2006. 

Statement of Need: 

The Food and Drug Administration 

(FDA) is revising its infant formula 

regulations in 21 CFR Parts 106 and 

107 to establish requirements for 

current good manufacturing practices 

(CGMP), including audits; to establish 

requirements for quality factors; and to 

amend FDA’s quality control 

procedures, notification, and record 

and reporting requirements for infant 

formula. FDA is taking this action to 

improve the protection of infants who 

consume infant formula products. 

Summary of Legal Basis: 

The Infant Formula Act of 1980 (the 

1980 act) (Pub. L. 96-359) amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) to include § 412 (21 U.S.C. 

350a). This law is intended to improve 

protection of infants consuming infant 

formula products by establishing 

greater regulatory control over the 

formulation and production of infant 

formula. In 1982, FDA adopted infant 

formula recall procedures in subpart D 

of 21 CFR part 107 of its regulations 

(47 FR 18832, April 30, 1982), and 

infant formula quality control 

procedures in subpart B of 21 CFR Part 

106 (47 FR 17016, April 20, 1982). In 

1985, FDA further implemented the 

1980 act by establishing subparts B, C, 

and D in 21 CFR Part 107 regarding 

the labeling of infant formula, exempt 

infant formulas, and nutrient 

requirements for infant formula, 

respectively (50 FR 1833, January 14, 

1985; 50 FR 48183, November 22, 1985; 

and 50 FR 45106, October 30, 1985). 

In 1986, Congress, as part of the AntiDrug Abuse Act of 1986 (PL 99-570) 

(the 1986 amendments), amended § 412 

of the act to address concerns that had 

been expressed by Congress and 

consumers about the 1980 act and its 

implementation related to the 


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sufficiency of quality control testing, 

CGMP, recordkeeping, and recall 

requirements. The 1986 amendments: 

(1) state that an infant formula is 

deemed to be adulterated if it fails to 

provide certain required nutrients, fails 

to meet quality factor requirements 

established by the Secretary (and, by 

delegation, FDA), or if it is not 

processed in compliance with the 

CGMP and quality control procedures 

established by the Secretary; (2) require 

that the Secretary issue regulations 

establishing requirements for quality 

factors and CGMP, including quality 

control procedures; (3) require that 

infant formula manufacturers regularly 

audit their operations to ensure that 

those operations comply with CGMP 

and quality control procedure 

regulations; (4) expand the 

circumstances in which firms must 

make a submission to the agency to 

include when there is a major change 

in an infant formula or a change that 

may affect whether the formula is 

adulterated; (5) specify the nutrient 

quality control testing that must be 

done on each batch of infant formula; 

(6) modify the infant formula recall 

requirements; and (7) give the Secretary 

authority to establish requirements for 

retention of records, including records 

necessary to demonstrate compliance 

with CGMP and quality control 

procedures. In 1989, the agency 

implemented the provisions on recalls 

(sections 412(f) and (g) of the act) by 

establishing subpart E in 21 CFR part 

107 (54 FR 4006, January 27, 1989). In 

1991, the agency implemented the 

provisions on record and record 

retention requirements by revising 21 

CFR 106.100 (56 FR 66566, December 

24, 1991). 

The agency has already promulgated 

regulations that respond to a number 

of the provisions of the 1986 

amendments. The final rule would 

address additional provisions of these 

amendments. 

Alternatives: 

The 1986 amendments require the 

Secretary (and, by delegation, FDA) to 

establish, by regulation, requirements 

for quality factors and CGMPs, 

including quality control procedures. 

Therefore, there are no alternatives to 

rulemaking. 

Anticipated Cost and Benefits: 

FDA estimates that the costs from the 

final rule to producers of infant formula 

would include first year and recurring 

costs (e.g., administrative costs, 

implementation of quality controls, 

records, audit plans and assurances of 

quality factors in new infant formulas). 

FDA anticipates that the primary 

benefits would be a reduced risk of 

illness due to Cronobacter sakazakii 

and Salmonella spp in infant formula. 

Additional benefits stem from the 

quality factors requirements that would 

assure the healthy growth of infants 

consuming infant formula. Monetized 

estimates of costs and benefits for this 

final rule are not available at this time. 

The analysis for the proposed rule 

estimated costs of less than $1 million 

per year. FDA was not able to quantify 

benefits in the analysis for the 

proposed rule. 

Risks: 

Special controls for infant formula 

manufacturing are especially important 

because infant formula, particularly 

powdered infant formula, is an ideal 

medium for bacterial growth and 

because infants are at high risk of 

foodborne illness because of their 

immature immune systems. In addition, 

quality factors are of critical need to 

assure that the infant formula supports 

healthy growth in the first months of 

life when infant formula may be an 

infant’s sole source of nutrition. The 

provisions of this rule will address 

weaknesses in production that may 

allow contamination of infant formula, 

including, contamination with C. 

sakazakii and Salmonella spp which 

can lead to serious illness with 

devastating sequelae and/or death. The 

provisions would also assure that new 

infant formulas support healthy growth 

in infants. 

Timetable: 

Action Date FR Cite 

NPRM 07/09/96 61 FR 36154 

NPRM Comment 

Period End 

12/06/96 

NPRM Comment 

Period Reopened 

04/28/03 68 FR 22341 

NPRM Comment 

Period Extended 

06/27/03 68 FR 38247 

NPRM Comment 

Period End 

08/26/03 

NPRM Comment 

Period Reopened 

08/01/06 71 FR 43392 

NPRM Comment 

Period End 

09/15/06 

Final Action 10/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Benson Silverman 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition (HFS–850) 

5100 Paint Branch Parkway 

College Park, MD 20740 

Phone: 301 436–1459 

Email: benson.silverman@fda.hhs.gov 

Related RIN: Split from 0910–AA04 

RIN: 0910–AF27 

HHS—FDA 

49. MEDICAL DEVICE REPORTING; 

ELECTRONIC SUBMISSION 

REQUIREMENTS 

Priority: 

Other Significant 

Legal Authority: 

21 USC 352; 21 USC 360; 21 USC 360i; 

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

CFR Citation: 

21 CFR 803 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration 

(FDA) is proposing to amend its 

postmarket medical device reporting 

regulations to require that 

manufacturers, importers, and user 

facilities submit mandatory reports of 

medical device adverse events to the 

Agency in an electronic format that 

FDA can process, review, and archive. 

FDA is taking this action to improve 

the Agency’s systems for collecting and 

analyzing postmarketing safety reports. 

The proposed change would help the 

Agency to more quickly review safety 

reports and identify emerging public 

health issues. 

Statement of Need: 

The final rule would require user 

facilities and medical device 

manufacturers and importers to submit 

medical device adverse event reports in 

electronic format instead of using a 

paper form. FDA is taking this action 

to improve its adverse event reporting 

program by enabling it to more quickly 

receive and process these reports. 


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Summary of Legal Basis: 

The Agency has legal authority under 

section 519 of the Federal Food, Drug, 

and Cosmetic Act to require adverse 

event reports. The proposed rule would 

require manufacturers, importers, and 

user facilities to change their 

procedures to send reports of medical 

device adverse events to FDA in 

electronic format instead of using a 

hard copy form. 

Alternatives: 

The alternatives to this rulemaking 

include not updating the medical 

device reporting requirements and not 

requiring submission of this 

information in electronic format. For 

over 20 years, medical device 

manufacturers, importers, and user 

facilities have sent adverse event 

reports to FDA on paper forms. 

Processing paper forms is a timeconsuming and expensive process. FDA 

believes this rulemaking is the 

preferable alternative. 

Anticipated Cost and Benefits: 

The principal benefit would be to 

public health because the increased 

speed in the processing and analysis 

of the more than 200,000 medical 

device reports currently submitted 

annually on paper. In addition, 

requiring electronic submission would 

reduce FDA annual operating costs by 

$1.25 million. 

The total one-time cost for modifying 

SOPs and establishing electronic 

submission capabilities is estimated to 

range from $58.6 million to $79.7 

million. Annually recurring costs 

totaled $8.5 million and included 

maintenance of electronic submission 

capabilities, including renewing the 

electronic certificate, and for some 

firms the incremental cost to maintain 

high-speed internet access. 

Risks: 

None 

Timetable: 

Action Date FR Cite 

NPRM 08/21/09 74 FR 42310 

NPRM Comment 

Period End 

11/19/09 

Final Action 09/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Myrna Hanna 

Regulations Staff 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Devices and Radiological 

Health 

10903 New Hampshire Avenue 

WO–66 Room 4436 

Silver Spring, MD 20993 

Phone: 301 796–5739 

Fax: 301 847–8144 

Email: myrna.hanna@fda.hhs.gov 

RIN: 0910–AF86 

HHS—FDA 

50. ∑ REGULATIONS RESTRICTING 

THE SALE AND DISTRIBUTION OF 

CIGARETTES AND SMOKELESS 

TOBACCO TO PROTECT CHILDREN 

AND ADOLESCENTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect State, local or 

tribal governments and the private 

sector. 

Legal Authority: 

21 USC 301 et seq., The Federal Food, 

Drug, and Cosmetic Act; PL 111–31, 

Family Smoking Prevention and 

Tobacco Control Act 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, March 22, 2010, Public 

Law 111–30 sections 6(c)(1) and 

102(a)(1). 

Family Smoking Prevention and 

Tobacco Control Act §§ 6(c)(1) and 

102(a)(1) require publication of this 

final rule within 270 days of 

enactment. 

Abstract: 

This rule establishes regulations 

restricting the sale and distribution of 

cigarettes and smokeless tobacco to 

children and adolescents, implementing 

section 102 of the Family Smoking 

Prevention and Tobacco Control Act 

(FSPTCA). FSPTCA sections 102 and 

6(c)(1) require the Secretary to publish, 

within 270 days of enactment, a final 

rule regarding cigarettes and smokeless 

tobacco. This final rule must be 

identical, except for several changes 

identified in section 102(a)(2) of 

FSPTCA, to part 897 of the regulations 

promulgated by the Secretary of HHS 

in the August 28, 1996 issue of the 

Federal Register (61 FR 44396). 

This final rule prohibits the sale of 

cigarettes and smokeless tobacco to 

individuals under the age of 18 and 

requires manufacturers, distributors, 

and retailers to comply with certain 

conditions regarding access to, and 

promotion of, these products. Among 

other things, the final rule requires 

retailers to verify a purchaser’s age by 

photographic identification. It also 

prohibits, with limited exception, free 

samples and prohibits the sale of these 

products through vending machines 

and self-service displays except in 

facilities where individuals under the 

age of 18 are not present or permitted 

at any time. The rule also limits the 

advertising and labeling to which 

children and adolescents are exposed. 

The rule accomplishes this by generally 

restricting advertising to which 

children and adolescents are exposed 

to a black-and-white, text-only format. 

The rule also prohibits the sale or 

distribution of brand-identified 

promotional, non-tobacco items such as 

hats and tee shirts. Furthermore, the 

rule prohibits sponsorship of sporting 

and other events, teams, and entries in 

a brand name of a tobacco product, but 

permits such sponsorship in a 

corporate name. 

Statement of Need: 

FDA is issuing this regulation as 

required in section 102 of FSPTCA. 

Summary of Legal Basis: 

The legal authority to issue this 

regulation includes section 102 of 

FSPTCA. 

Alternatives: 

FDA’s statutory requirement to issue 

this rule, in its current form, does not 

provide for the consideration of any 

alternatives. 

Anticipated Cost and Benefits: 

Congress has recognized that tobacco 

use is the foremost preventable cause 

of premature death in America. It 

causes over 400,000 deaths in the 

United States each year, and 

approximately 8,600,000 Americans 

have chronic illnesses related to 

smoking. 

Based on FDA’s prior analysis of a 

similar rule, implementing nearly 


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identical provisions (61 FR 44396), the 

Food and Drug Administration (FDA) 

believes this rulemaking will have a 

significant economic impact. 

Costs associated with this rulemaking 

will include one-time costs to 

manufacturers to remove prohibited 

point-of-sale promotional items and 

self-service displays. Most costs to 

retail establishments are attributable to 

the new labor costs associated with the 

self-service restrictions, costs for 

training employees to verify customer 

ages, for routinely checking I.D.’s of 

young purchasers. There are also costs 

seen by consumers in delay in checkout 

lines. Distributional and transitional 

costs are also expected. 

Risks: 

Congress has found that these 

regulations will directly and materially 

advance the Federal Government’s 

substantial interest in reducing the 

number of children and adolescents 

who use cigarettes and smokeless 

tobacco and in preventing the lifethreatening health consequences 

associated with tobacco use. An 

overwhelming majority of Americans 

who use tobacco products begin using 

such products while they are minors 

and become addicted to the nicotine in 

those products before reaching the age 

of 18. Tobacco advertising and 

promotion play a crucial role in the 

decision of these minors to begin using 

tobacco products. Less restrictive and 

less comprehensive approaches have 

not and will not be effective in 

reducing the problems addressed by 

such regulations. The reasonable 

restrictions on the advertising and 

promotion of tobacco products 

contained in such regulations will lead 

to a significant decrease in the number 

of minors using and becoming addicted 

to those products. 

Timetable: 

Action Date FR Cite 

Final Rule 03/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal, Local, State, Tribal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Philip R. Desjardins 

Department of Health and Human 

Services 

Food and Drug Administration 

WO66, Room 5449 

10903 New Hampshire 

Silver Spring, MD 20993 

Phone: 301 796–5683 

Email: philip.desjardins@fda.hhs.gov 

RIN: 0910–AG33 

HHS—Centers for Medicare & 

Medicaid Services (CMS) 

PROPOSED RULE STAGE 

51. ∑ ELECTRONIC HEALTH RECORD 

(EHR) INCENTIVE PROGRAM 

(CMS–0033–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

PL 111–5 (The American Recovery and 

Reinvestment Act of 2009, Title IV of 

Division B, Medicare and Medicaid 

Health Information Technology) 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Other, Statutory, October 1, 2010, Date 

can start incentive payments to 

hospitals (Medicare). 

Other, Statutory, January 1, 2011, Date 

can start incentive payments to eligible 

professionals (Medicare). 

Establishes policies and procedures 

required before the incentive program 

can begin. Additionally supplemental 

payments are available in 2011 and 

2012. If eligible professionals and 

hospitals are not meaningful Electronic 

Health Record users by 2015 there will 

be a Medicare payment adjustment 

imposed. 

Abstract: 

The Medicare and Medicaid Health IT 

provisions in the American Recovery 

and Reinvestment Act of 2009 promote 

the adoption and meaningful use of 

certified electronic health records 

(EHRs). The Recovery Act authorized 

incentive payments for eligible 

professionals (EPS) and hospitals 

participating in Medicare and Medicaid 

for becoming meaningful users of 

certified EHRs. The law established 

maximum annual incentive amounts 

and includes Medicare penalties for 

failing to meaningfully use EHRs 

beginning in 2015 for professionals and 

hospitals that fail to adopt certified 

EHRs. 

Statement of Need: 

This rule would implement provisions 

of the American Recovery and 

Reinvestment Act of 2009 (Recovery 

Act) that authorizes incentive payments 

to EPS and eligible hospitals 

participating in the Medicare and 

Medicaid programs for adopting and 

becoming meaningful users of certified 

EHR technology. 

Summary of Legal Basis: 

Title IV of Division B of the Recovery 

Act includes provisions to promote the 

adoption of interoperable health 

information technology (HIT) to 

promote the meaningful use of health 

information technology to improve the 

quality and value of American health 

care. These provisions together with 

Title XIII of Division A of the Recovery 

Act may be cited as the ‘‘Health 

Information Technology for Economic 

and Clinical Health Act’’ or the 

‘‘HITECH Act’’. CMS is charged with 

developing the incentive programs 

outlined in Division B, Title IV of the 

HITECH Act. 

Alternatives: 

There are no alternatives; this is a 

statutory requirement. 

Anticipated Cost and Benefits: 

Under Medicare, payment adjustments 

will be made starting in 2015 if EPs 

and eligible hospitals are not 

meaningful users of certified EHR 

technology. The benefits of the 

adoption of HIT are difficult to 

quantify. There is the potential of 

reduced medical costs through 

efficiency improvements. Additionally, 

HIT could help prevent medical errors 

and adverse drug interactions. 

Risks: 

If this rule is not published, CMS will 

be unable to pay incentives for the 

adoption and meaningful use of EHRs. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/09 

Regulatory Flexibility Analysis 

Required: 

Undetermined 


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Government Levels Affected: 

State 

Federalism: 

Undetermined 

Agency Contact: 

Elizabeth S. Holland 

Health Insurance Specialist 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mailstop S2–26–17 

7500 Security Blvd. 

Baltimore, MD 21244 

Phone: 410 786–1309 

Email: elizabeth.holland@cms.hhs.gov 

Related RIN: Related to 0991–AB58 

RIN: 0938–AP78 

HHS—CMS 

52. ∑ REVISIONS TO PAYMENT 

POLICIES UNDER THE PHYSICIAN 

FEE SCHEDULE AND PART B FOR CY 

2011 (CMS–1503–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Social Security Act, sec 1102; Social 

Security Act, sec 1871 

CFR Citation: 

42 CFR 405; 42 CFR 410 to 411; 42 

CFR 413 to 414; 42 CFR 426 

Legal Deadline: 

Final, Statutory, November 1, 2010. 

Abstract: 

This major proposed rule would revise 

payment polices under the physician 

fee schedule, as well, as other policy 

changes to payment under Part B for 

CY 2011. (The statute requires the 

proposed and subsequent final rule 

publish by 11/1/10.) 

Statement of Need: 

The statute requires that we establish 

each year, by regulation, payment 

amounts for all physicians’ services 

furnished in all fee schedule areas. This 

major proposed rule would make 

changes affecting Medicare Part B 

payment to physicians and other Part 

B suppliers. 

The final rule has a statutory 

publication date of November 1, 2010, 

an implementation date of January 1, 

2011. 

Summary of Legal Basis: 

Section 1848 of the Social Security Act 

(the Act) establishes the payment for 

physician services provided under 

Medicare. Section 1848 of the Act 

imposes a deadline of no later than 

November 1 for publication of the final 

physician fee schedule rule. 

Alternatives: 

None. This is a statutory requirement. 

Anticipated Cost and Benefits: 

Total expenditures will be adjusted for 

CY 2011. 

Risks: 

If this regulation is not published 

timely, physician services will not be 

paid appropriately. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Cassandra Black 

Director, Division of Practitoner Services 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mail Stop C4–01–26 

7500 Security Blvd 

Baltimore, MD 21244 

Phone: 410 786–4545 

Email: cassandra.black@cms.hhs gov 

RIN: 0938–AP79 

HHS—CMS 

53. ∑ PROPOSED CHANGES TO THE 

HOSPITAL INPATIENT PROSPECTIVE 

PAYMENT SYSTEMS FOR ACUTE 

CARE HOSPITALS AND FY 2011 

RATES AND TO THE LONG–TERM 

CARE HOSPITAL PPS AND RY 2011 

RATES (CMS–1498–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Sec 1886(d) of the Social Security Act 

CFR Citation: 

42 CFR 412 

Legal Deadline: 

NPRM, Statutory, April 1, 2010. 

Final, Statutory, August 1, 2010. 

Abstract: 

Proposed Changes to the Hospital 

Inpatient Prospective Payment Systems 

for Acute Care Hospitals and FY 2011 

Rates and to the Long Term Care 

Hospital PPS and RY 2011 Rates 

Statement of Need: 

CMS annually revises the Medicare 

hospital inpatient prospective payment 

systems (IPPS) for operating and 

capital-related costs to implement 

changes arising from our continuing 

experience with these systems. In 

addition, we describe the proposed 

changes to the amounts and factors 

used to determine the rates for 

Medicare hospital inpatient services for 

operating costs and capital-related 

costs. Also, CMS annually updates the 

payment rates for the Medicare 

prospective payment system (PPS) for 

inpatient hospital services provided by 

long-term care hospitals (LTCHs). The 

proposed rule solicits comments on the 

proposed IPPS and LTCH payment 

rates and new policies. CMS will issue 

a final rule containing the payment 

rates for the 2011 IPPS and LTCHs at 

least 60 days before October 1, 2010. 

Summary of Legal Basis: 

The Social Security Act (the Act) sets 

forth a system of payment for the 

operating costs of acute care hospital 

inpatient stays under Medicare Part A 

(Hospital Insurance) based on 

prospectively set rates. The Act 

requires the Secretary to pay for the 

capital-related costs of hospital 

inpatient and Long Term Care stays 

under a prospective payment system 

(PPS). Under these PPSs, Medicare 

payment for hospital inpatient and 

Long Term Care operating and capitalrelated costs is made at predetermined, 

specific rates for each hospital 

discharge. These changes would be 

applicable to services furnished on or 

after October 1, 2010. 

Alternatives: 

None. This is a statutory requirement. 

Anticipated Cost and Benefits: 

Total expenditures will be adjusted for 

FY 2011. 

Risks: 

If this regulation is not published 

timely, inpatient hospital and LTCH 


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services will not be paid appropriately 

beginning October 1, 2010 

Timetable: 

Action Date FR Cite 

NPRM 04/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Tiffany Swygert 

Health Insurance Specialist 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mailstop C4–25–11 

7500 Security Blvd. 

Baltimore, MD 21244 

Phone: 410 786–4642 

Email: tiffany.swygert@cms.hhs.gov 

RIN: 0938–AP80 

HHS—CMS 

54. ∑ CHANGES TO THE HOSPITAL 

OUTPATIENT PROSPECTIVE 

PAYMENT SYSTEM AND 

AMBULATORY SURGICAL CENTER 

PAYMENT SYSTEM FOR CY 2011 

(CMS–1504–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Sec 1833 of the Social Security Act 

CFR Citation: 

42 CFR 410 to 413; 42 CFR 416 

Legal Deadline: 

Final, Statutory, November 1, 2010. 

Abstract: 

This major proposed rule would revise 

the Medicare hospital outpatient 

prospective payment system to 

implement applicable statutory 

requirements and changes arising from 

our continuing experience with this 

system. In addition, the proposed rule 

describes proposed changes to the 

amounts and factors used to determine 

the payment rates for Medicare hospital 

outpatient services paid under the 

prospective payment system. The rule 

also proposes changes to the 

Ambulatory Surgical Center Payment 

System list of services and rates. These 

changes would be applicable to services 

furnished on or after January 1 

annually. (The proposed and 

subsequent final rule must publish by 

11/1/10.) 

Statement of Need: 

Medicare pays over 4,200 hospitals for 

outpatient department services under 

the hospital outpatient prospective 

payment system (OPPS). The OPPS is 

based on groups of clinically similar 

services called ambulatory payment 

classification groups (APCs). CMS 

annually revises the APC payment 

amounts based on claims data, 

proposes new payment polices, and 

updates the payments for inflation 

using the hospital operating market 

basket. The proposed rule solicits 

comments on the proposed OPPS 

payment rates and new policies. This 

rule does not impact payments to 

critical access hospitals as they are not 

paid under the OPPS. Medicare pays 

roughly 5,000 Ambulatory Surgical 

Centers (ASCs) under the ASC payment 

system. CMS annually revises the 

payment under the ASC payment 

system, proposes new policies, and 

updates payments for inflation using 

the Consumer Price Index for All Urban 

Consumers (CPI-U). CMS will issue a 

final rule containing the payment rates 

for the 2011 OPPS and ASC payment 

system at least 60 days before January 

1, 2011. 

Summary of Legal Basis: 

Section 1833 of the Social Security Act 

establishes Medicare payment for 

hospital outpatient services. The final 

rule revises the Medicare hospital 

OPPS to implement applicable statutory 

requirements and changes arising from 

our continuing experience with this 

system. In addition, the proposed and 

final rules describe changes to the 

outpatient APC system, relative 

payment weights, outlier adjustments, 

and other amounts and factors used to 

determine the payment rates for 

Medicare hospital outpatient services 

paid under the prospective payment 

system as well as changes to the rates 

and services paid under the ASC 

payment system. These changes would 

be applicable to services furnished on 

or after January 1, 2011. 

Alternatives: 

None. This is a statutory requirement. 

Anticipated Cost and Benefits: 

Total expenditures will be adjusted for 

CY 2011. 

Risks: 

If this regulation is not published 

timely, outpatient hospital and ASC 

services will not be paid appropriately 

beginning January 1, 2011. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal 

Federalism: 

Undetermined 

Agency Contact: 

Alberta Dwived 

Health Insurance Specialist 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mail Stop C5–01–26 

7500 Security Blvd, 

Baltimore,, MD 21244 

Phone: 410 786–0763 

Email: alberta.dwived@cms.hhs.gov 

RIN: 0938–AP82 

HHS—CMS 

FINAL RULE STAGE 

55. HIPAA MENTAL HEALTH PARITY 

AND ADDICTION EQUITY ACT OF 

2008 AMENDMENTS (CMS–4140–IFC) 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Mental Health Parity and Addication 

Equity Act of 2008 (P.L.110–343) 

CFR Citation: 

45 CFR 146.136 


erowe on DSK5CLS3C1PROD with RULES
64212 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan 

Legal Deadline: 

Final, Statutory, October 3, 2009, 

Interim final regulation. 

Abstract: 

This rule implements statutory changes 

to the Public Health Services Act 

(PHSA) affecting the group health 

insurance markets and non-federal 

governmental plans, made by the 

Mental Health Parity and Addiction 

Equity Act of 2008. 

Statement of Need: 

This rule is needed to implement 

MHPAEA, which expands the existing 

Mental Health parity law to include 

substance abuse disorders and to 

require parity for mental health and 

substance abuse disorder benefits in 

treatment limitations and financial 

requirements. 

Summary of Legal Basis: 

The Public Health Service Act and 

MHPAEA provide the authority to 

implement this rule. 

Alternatives: 

Since this is a statutory requirement, 

no alternatives were considered. 

Anticipated Cost and Benefits: 

Promulgation of this rule will provide 

greater access to mental health and 

substance abuse disorder treatments by 

requiring group health plans to provide 

better coverage for those treatments. 

Risks: 

This rule addresses the risk of 

individuals not being able to obtain 

necessary mental health and/or 

substance abuse disorder treatment 

because of limited health coverage for 

those treatments. By increasing access 

to treatment for mental health 

conditions and substance abuse 

disorders, this rule will also reduce the 

stigma experienced by millions of 

Americans who are afflicted with these 

conditions and allow them to remain 

in the workforce. 

Timetable: 

Action Date FR Cite 

Request for 

Information 

04/28/09 74 FR 19155 

RFI Comment Period 

End 

05/28/09 

Interim Final Rule 01/00/10 

Action Date FR Cite 

Interim Final Rule 

Comment Period 

End 

03/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Jim Mayhew 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

7500 Security Boulevard 

Baltimore, MD 21244 

Phone: 410 786–9244 

Email: jim.mayhew@cms.hhs.gov 

Related RIN: Related to 1210–AB30, 

Related to 1545–BI70 

RIN: 0938–AP65 

BILLING CODE 4150–24–S 


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