8184 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,251 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by April 24, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 22, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 3, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3128 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004P–0262] 

Withdrawal of Approval of 128 

Suitability Petitions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 128 suitability petitions. 

This action is being taken in accordance 

with the Pediatric Research Equity Act 

of 2003 (PREA). Prior to PREA’s 

enactment, FDA had approved these 

suitability petitions to permit 

abbreviated new drug applications 

(ANDAs) to be submitted for drugs that 

had a different active ingredient, dosage 

form, or route of administration than 

their reference listed drugs (RLDs). 

However, these approval decisions are 

being withdrawn because ANDAs were 

never submitted and PREA requires that 

all applications submitted on or after 

April 1, 1999, for a new active 

ingredient, new indication, new dosage 

form, new dosing regimen, or new route 

of administration contain an assessment 

of the safety and effectiveness of the 

drug for the claimed indications in 

relevant pediatric subpopulations 

unless the requirement is waived or 

deferred. This action is being taken 

without prejudice. Any of the suitability 

petitions may be resubmitted for action 

by the agency in accordance with 

current law. 

DATES: This notice is effective March 26, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Cecelia M. Parise, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5845. 

SUPPLEMENTARY INFORMATION: PREA 

(Public Law 108–155) was enacted on 

December 3, 2003. Among other things, 

section 2 of PREA requires that all drug 

applications submitted on or after April 

1, 1999, for a new active ingredient, new 

indication, new dosage form, new 

dosing regimen, or new route of 

administration contain an assessment of 

the safety and effectiveness of the drug 

for the claimed indications in relevant 

pediatric subpopulations unless the 

requirement is waived or deferred. As a 

result, FDA is withdrawing its approval 

for 128 suitability petitions for which 

ANDAS were never submitted. The 

approval decisions, made prior to the 

enactment of PREA, would have 

permitted ANDAs to be submitted for 

certain drugs that have a different active 

ingredient, dosage form, or route of 

administration than their RLDs. No 

ANDAs were submitted for these drugs 

pursuant to these suitability petitions 

prior to April 1, 1999, and any such 

application submitted on or after April 

1, 1999, would be required to contain 

the safety and effectiveness assessments 

required by PREA, unless waived or 

deferred. According to § 314.93(e)(1)(i) 

(21 CFR 314.93(e)(1)(i)), a suitability 

petition may not be approved if 

investigations must be conducted to 

show the safety and effectiveness of the 

drug product. In addition, according to 

§ 314.93(f), FDA may withdraw 

approval of a suitability petition if it 

receives information demonstrating that 

the petition no longer satisfies the 

conditions of § 314.93(e). Under PREA, 

safety and effectiveness investigations 

in pediatric subpopulations would be 

required for the drug products proposed 

by these suitability petitions, unless the 

requirement is waived or deferred. 

Therefore, these suitability petitions no 

longer satisfy the regulatory 

requirements for approval. Pursuant to 

§ 314.93(f), FDA is withdrawing 

approval of the 128 suitability petitions 

listed in the following table: 

Petition No. Drug Petitioner 

82N–0032/CP6 Chlorzoxazone 500 milligrams (mg) Mikart, Inc. 

84N–0116/CP1 Disopyramide Phosphate 200 mg or 300 mg Biocraft Laboratories, Inc. 

84P–0228/CP1 Acetaminophen 500 mg, 

Codeine Phosphate 30 mg or 60 mg 

McNeil Pharmaceutical 

85P–0067/CP1 Methyltestosterone 25 mg Star Pharmaceuticals 

85P–0074/CP1 Hydralazine Hydrochloride 25 mg/5 milliliters (mL) Roxane Laboratories, Inc. 

85P–0081/CP1 Flurazepam Hydrochloride 30 mg/mL Do. 

85P–0084/CP1 Vincristine Sulfate 2 mg Bristol Laboratories 


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Petition No. Drug Petitioner 

85P–0091/CP1 Flurazepam Hydrochloride 15 mg/5 mL Roxane Laboratories, Inc. 

85P–0095/CP1 Brompheniramine Maleate 12 mg, 

Pseudoephedrine Hydrochloride 120 mg 

UAD Laboratories, Inc. 

85P–0129/CP1 Propranolol Hydrochloride 160 mg Verex Laboratories, Inc. 

85P–0140/CP1 Dexbrompheniramine Maleate 6 mg, 

Pseudoephedrine Hydrochloride 120 mg 

Central Pharmaceuticals, Inc. 

85P–0140/CP2 Dexbrompheniramine Maleate 6 mg, 

Pseudoephedrine Sulfate 120 mg 

Do. 

85P–0147/CP1 Ketoconazole 20 mg/mL Janssen Pharmaceutica 

85P–0197/CP1 Propranolol Hydrochloride 80 mg, 120 mg, 160 mg Forest Laboratories 

85P–0215/CP1 Disulfiram 500 mg/30 mL Paddock Laboratories 

85P–0238/CP2 Dexbrompheniramine Maleate 6 mg, 

Phenylpropanolamine Hydrochloride 75 mg 

Bock Pharmacal Co. 

85P–0269/CP1 Codeine Phosphate 10 mg/5 mL, 

Dexbrompheniramine Maleate 1 mg/5 mL, 

Phenylpropanolamine Hydrochloride 12.5 mg/5 mL 

Do. 

85P–0423/CP1 Benztropine Mesylate 0.5 mg/5 mL RIM Consulting Corp. 

85P–0492/CP1 Azatadine Maleate 1 mg, 

Phenylpropanolamine Hydrochloride 75 mg 

Smith, Kline & French Laboratories 

85P–0499/CP1 Diazepam 2 mg/5 mL Carolina Medical Products Co. 

85P–0510/CP1 Spironolactone 25 mg/5 mL Do. 

85P–0515/CP1 Lorazepam 0.5 mg, 1 mg, or 2 mg Wyeth Laboratories, Inc. 

85P–0516/CP1 Oxazepam 15 mg or 30 mg Do. 

85P–0543/CP1 Acetaminophen 300 mg, 

Codeine Phosphate 30 mg 

Softan, Inc. 

85P–0543/CP2 Acetaminophen 500 mg, 

Codeine Phosphate 7.5 or 15 mg 

Do. 

85P–0543/CP3 Acetaminophen 500 mg, 

Oxycodone Hydrochloride 5 mg 

Do. 

85P–0563/CP1 Ibuprofen 300, 400, or 600 mg Do. 

85P–0581/CP1 Acetaminophen 500 mg, 

Propoxyphene Hydrochloride 32 mg 

Do. 

86P–0045/CP1 Propranolol Hydrochloride 10, 20, 40, 60, 80, 90 mg Nutripharm, Inc. 

86P–0055/CP1 Spironolactone 25 mg/5 mL Carolina Medical Products Co. 

86P–0123/CP1 Cholestyramine 4 grams (g) Parke-Davis, Division of Warner-Lambert Co. 

86P–0200/CP1 Acetaminophen 650 mg, 

Codeine Phosphate 15 mg 

Mikart, Inc. 

86P–0242/CP1 Floxuridine 500 mg/5 mL Quad Pharmaceuticals, Inc. 

86P–0292/CP1 Lorazepam 1 mg/5 mL Roxane Laboratories, Inc. 

86P–0359/CP1 Aspirin 356.4 mg, 

Caffeine 30 mg, 

Dihydrocodeine Bitartrate 16 mg 

Central Pharmaceuticals, Inc. 

86P–0361/CP1 Acetaminophen 325 mg, 

Aspirin 325 mg, 

Codeine Phosphate 30 mg 

Bock Pharmacal Co. 


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Petition No. Drug Petitioner 

86P–0427/CP1 Hydrochlorothiazide 50 mg, 

Triamterene 75 mg 

Par Pharmaceutical, Inc. 

86P–0474/CP1 Cholestyramine 500 mg Bristol-Myers Squibb 

87P–0004/CP1 Fluocinonide 0.05% Richard Hamer Assoc. 

87P–0037/CP1 Lorazepam 0.5 mg, 1 mg, 2 mg Applied Laboratories, Inc. 

87P–0101/CP1 Verapamil Hydrochloride 40 mg/5 mL or 80 mg/5 mL MY-K Laboratories, Inc. 

87P–0233/CP1 Verapamil Hydrochloride 120 mg or 240 mg Searle Research & Development 

87P–0242/CP1 Ibuprofen 800 mg Sidmak Laboratories, Inc. 

87P–0265/CP1 Dexbrompheniramine Maleate 6 mg, 

Phenypropanolamine Hydrochloride 75 mg 

Bock Pharmacal Co. (King & Spalding) 

87P–0268/CP1 Loperamide Hydrochloride 2 mg Kross, Inc. 

87P–0301/CP1 Cholestyramine Resin 4 g Ciba-Geigy Corp. 

87P–0314/CP1 Clemastine Fumarate 1.34 mg, 

Pseudoephedrine Hydrochloride 120 mg 

Sandoz Consumer Healthcare Group 

87P–0323/CP1 Acetaminophen 160 mg/5 mL, 

Codeine Phosphate 6 mg/5 mL 

Kleinfeld, Kaplan & Becker 

87P–0335/CP1 Triamterene 50 mg, 

Hydrochlorothiazide 25 mg 

Par Pharmaceutical, Inc. 

87P–0340/CP1 Nifedipine 10 mg or 20 mg Do. 

87P–0367/CP1 Phenytoin Sodium 100 mg, 250 mg/vial Lyphomed, Inc. 

87P–0399/CP1 Propranolol Hydrochloride 40 mg or 80 mg/5 mL, 

Hydrochlorothiazide 25 mg/5 mL 

Burditt, Bowles, Radzius & Rudberry 

88P–0011/CP1 Cyclophosphamide 20 mg/mL, 500 mL pharmacy bulk pack (PBP) Baxter Healthcare Corp. 

88P–0036/CP1 Chlorhexidine Gluconate 0.5% Arent, Fox, Kinter, Plotkin & Kahn 

88P–0061/CP1 Homatropine Methylbromide 1.5 mg, 

Hydrocodone Bitartrate 5 mg 

Kleinfeld, Kaplan & Becker 

88P–0149/CP1 Leucovorin Calcium 1 mg/mL Roxane Laboratories, Inc. 

88P–0277/CP1 Quinidine Sulfate 300 mg A. H. Robins 

88P–0350/CP1 Clemastine Fumarate 1.34 mg, 

Phenylpropanolamine Hydrochloride 75 mg 

Scientific Consulting of VA, Inc. 

88P–0379/CP1 Cyclophosphamide 20 mg/mL, 250 mL PBP Baxter Healthcare Corp. 

88P–0391/CP1 Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, or 50 mg B.F. Ascher & Co., Inc. 

89P–0028/CP1 Hydrocortisone Valerate 0.2% McKenna, Conner & Cuneo 

89P–0029/CP1 Hydrocortisone Valerate 0.2% Do. 

89P–0071/CP1 Morphine Sulfate 30 mg Ethypharm/Oxford Research Intl. Corp. 

89P–0399/CP1 Carbamazepine 200 mg/5 mL Guidelines, Inc. 

89P–0435/CP1 Pentamidine Isethionate 100 mg/mL Astra Pharmaceutical Products, Inc. 

90P–0049/CP1 Hydrocortisone Acetate 2.5% or 1% Ferndale Laboratories, Inc. 

90P–0084/CP1 Chlorzoxazone 250 mg Mikart, Inc. 

90P–0154/CP1 Hydrocortisone Acetate 1% Ferndale Laboratories, Inc. 

90P–0198/CP1 Clobetasol Propionate 0.05%, 

RLD = Temovate 

Kross, Inc. 


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Petition No. Drug Petitioner 

90P–0436/CP1 Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co. 

91P–0348/CP1 Albuterol Sulfate 4 mg Richard Hamer Associates, Inc. 

92P–0048/CP2 Triazolam 0.125 mg/5 mL Roxane Laboratories, Inc. 

92P–0101/CP1 Hydrocortisone Acetate 2.5% Hogan & Hartson 

92P–0282/CP1 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Hydrocodone Bitartrate 5 mg 

Mikart, Inc. 

92P–0282/CP2 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Hydrocodone Bitartrate 7.5 mg 

Do. 

92P–0282/CP3 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Hydrocodone Bitartrate 2.5 mg 

Do. 

92P–0282/CP4 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Hydrocodone Bitartrate 10 mg 

Do. 

92P–0332/CP1 Propranolol Hydrochloride 40 mg Flemington Pharmaceutical Corp. 

92P–0335/CP1 Albuterol Sulfate 2 mg, 4 mg WE Pharmaceuticals, Inc. 

92P–0336/CP1 Prednisone 5 mg or 10 mg Do. 

92P–0381/CP1 Cytarabine 20 mg/mL, 12.5 mL Bristol-Myers Squibb Co. 

92P–0500/CP1 Timethoprim 25 mg/5 mL Ascent Pharmaceuticals, Inc. 

93P–0048/CP1 Cimetidine 200, 300, 400 or 800 mg Flemington Pharmaceuticals Corp. 

93P–0049/CP1 Propranolol Hydrochloride 10, 20, 60, 80, 90 mg Do. 

93P–0314/CP1 Acetaminophen 500 mg, 

Codeine Phosphate 45 mg 

Mikart, Inc. 

93P–0332/CP1 Loperamide Hydrochloride 1 mg Asta Medica GmbH 

93P–0333/CP1 Prednisone 1, 2.5, 20, 50 mg Dura Pharmaceuticals 

93P–0346/CP1 Acetaminophen 325 mg, 

Butalbital 50 mg, 

Caffeine 40 mg, 

Hydrocodone Bitartrate 5 mg 

Mikart, Inc. 

93P–0367/CP1 Terfenadine 60 mg, 

Pseudoephedrine 120 mg 

Eurand America 

93P–0446/CP1 Morphine Sulfate 15 mg, 60 mg, 90 mg, 100 mg Ethypharm 

93P–0459/CP1 Methyltestosterone 25 mg ICN Pharmaceuticals, Inc. 

94P–0182/CP1 Acetaminophen 120 mg, 

Codeine Phosphate 12 mg 

WE Pharmaceuticals, Inc. 

94P–0186/CP1 Sulfamethoxazole 200 mg, 

Trimethoprim 40 mg 

Dura Pharmaceuticals 

94P–0199/CP1 Lorazepam 1 mg/10 mL Roxane Laboratories, Inc. 

94P–0210/CP1 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Codeine Phosphate 60 mg 

Mikart, Inc. 

94P–0211/CP1 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Codeine Phosphate 30 mg 

Do. 


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8188 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

Petition No. Drug Petitioner 

94P–0212/CP1 Acetaminophen 150 mg, 

Aspirin 180 mg, 

Codeine Phosphate 15 mg 

Do. 

94P–0263/CP1 Fluorouracil 5% Bradley Pharmaceuticals, Inc. 

94P–0432/CP1 Methylprednisolone 16 mg, 24 mg, 32 mg Dura Pharmaceuticals 

94P–0433/CP1 Leucovorin Calcium 10 mg/mL 350 mg vial Lederle Laboratories 

94P–0433/CP2 Leucovorin Calcium 10 mg/mL 5 mL vial Do. 

95P–0008/CP1 Captopril 25 mg/mL Roxane Laboratories, Inc. 

95P–0100/CP1 Carbidopa/Levodopa 25/100 mg, 25/250 mg Athena Neurosciences, Inc. 

95P–0223/CP1 Hydrocortisone Butyrate 0.1% McKenna & Cuneo, L.L.P. 

95P–0268/CP1 Acyclovir Sodium 5 mg/mL Wilmer, Cutler, Pickering 

95P–0277/CP1 Cholestyramine 2 g Mayrand Pharmaceuticals, Inc. 

95P–0279/CP1 Butalbital 50 mg, 

Acetaminophen 325 mg, 

Caffeine 40 mg, 

Hydrocodone Bitartrate 10 mg 

Mikart, Inc. 

95P–0279/CP2 Butalbital 50 mg, 

Acetaminophen 325 mg, 

Caffeine 40 mg, 

Hydrocodone Bitartrate 7.5 mg 

Do. 

95P–0279/CP3 Butalbital 50 mg, 

Acetaminophen 500 mg, 

Caffeine 40 mg, 

Hydrocodone Bitartrate 10 mg 

Do. 

95P–0279/CP4 Butalbital 50 mg, 

Acetaminophen 500 mg, 

Caffeine 40 mg, 

Hydrocodone Bitartrate 7.5 mg 

Do. 

95P–0326/CP1 Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co. 

95P–0328/CP1 Metronidazole 0.75% RNB Pharmaceutical Co. 

96P–0018/CP1 Potassium Chloride 20 milliequivalents (meq) KV Pharmaceutical Co. 

96P–0021/CP1 Aspirin 650 mg 

Butalbital 50 mg 

Savage Laboratories, Division of Altana, Inc. 

96P–0054/CP1 Potassium Chloride 10 meq KV Pharmaceutical Co. 

96P–0079/CP1 Pentoxyfylline 400 mg Do. 

96P–0307/CP1 Acyclovir 5% Pitney, Hardin, Kipp & Szuch 

96P–0376/CP1 Hydrocortisone Acetate 90 mg Do. 

96P–0510/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, 

RLD = Cardiazem CD 

Labopharm, Inc. 

97P–0155/CP1 Mefenamic Acid 250 mg Pitney, Hardin, Kipp & Szuch 

97P–0192/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, 

RLD = Dilacor XR 

Labopharm, Inc. 

97P–0195/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, 

RLD = Tiazac 

Do. 

97P–0387/CP1 Albuterol Sulfate 2 mg and 4 mg Richard Hamer Assoc., Inc. 

97P–0404/CP1 Famotidine 10 mg Thomas Blake, R.Ph. 


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Petition No. Drug Petitioner 

98P–0068/CP1 Clobetasol Propionate 0.05%, 

RLD = Temovate E 

Richard Hamer Associates, Inc. 

98P–0146/CP1 Ifosfamide 50 mg/mL, 20 mL, and 60 mL Mitchall G. Clark 

98P–0199/CP1 Captopril 25 mg/5 mL Miran Consulting, Inc. 

98P–0745/CP1 Econazole Nitrate 1% Do. 

This action is being taken without 

prejudice. Any of these petitions may be 

resubmitted for action by the agency in 

accordance with current law. 

Dated: February 13, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3043 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration will publish 

periodic summaries of proposed 

projects. To request more information 

on the proposed projects or to obtain a 

copy of the information collection 

plans, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Protection and 

Advocacy for Individuals with Mental 

Illness (PAIMI) Annual Program 

Performance Report (OMB No. 0930– 

0169)—Revision 

The Protection and Advocacy for 

Individuals with Mental Illness (PAIMI) 

Act, [42 U.S.C. 10801 et seq.] authorized 

funds to support protection and 

advocacy services on behalf of 

individuals with severe mental illness 

and severe emotional impairment who 

are at risk for abuse (including incidents 

of seclusion, restraint, and serious 

injuries or fatalities related to such 

incidents, neglect, residing in a public 

or private care or treatment facility. The 

PAIMI Program is managed by the 

Center for Mental Health Services 

(CMHS) within the Substance Abuse 

and Mental Health Services 

Administration (SAMHSA). 

Under the PAIMI Act, formula grant 

awards are made to governor-designated 

protection and advocacy (P&A) systems 

in each of the 50 states, the District of 

Columbia (Mayor), the American Indian 

Consortium [the Dine (Navajo) and Hopi 

Peoples in Northern Arizona and New 

Mexico), and five (5) territories—

American Samoa, Guam, the Northern 

Mariana Islands, the Commonwealth of 

Puerto Rico, and the U.S. Virgin Islands. 

The awards are used to provide legalbased advocacy services which ensure 

protection against violation of the 

constitutional and federal rights of 

individuals with significant (severe) 

mental illness (adults) and significant 

(severe) emotional impairment. 

In 2000, the PAIMI Act amendments, 

created a 57th P&A system—the 

American Indian Consortium and 

authorized P&A systems to serve PAIMIeligible individuals, as defined under 

the Act [42 U.S.C. at 10802 (4)], who 

reside in the community including their 

own homes. However, P&A services to 

PAIMI-eligible clients residing in the 

community is permissible only when 

the annual PAIMI appropriation met or 

exceeded $30 million, and that residents 

in public and private residential care or 

treatment facilities had service priority 

over community residents. The 

Children’s Health Act of 2000 (42 U.S.C. 

290aa et seq.), also referenced State P&A 

authority to obtain information on 

incidents of seclusion, restraint, and 

related deaths in certain facilities. 

The PAIMI Act requires each of the 57 

P & A systems to file an annual report, 

no later than January 1st, of its activities 

and accomplishments and to provide 

information on such topics as, the 

numbers of individuals served, types of 

complaints addressed, and the number 

of intervention strategies used to resolve 

the presenting issues. Under the Act, the 

PAIMI Advisory Council (PAC) of each 

P&A system is also required to submit 

its independent assessment of the 

effectiveness of the services provided to, 

and the activities conducted by, the 

P&A systems on behalf of PAIMI-eligible 

individuals and their family members, 

in a separate section of the PPR. 

The Developmental Disabilities 

Assistance and Bill of Rights Act of 

1975, referred to as the DD Act [42 

U.S.C. 6042 et seq.], created the State 

P&A systems. The Administration on 

Developmental Disabilities, within the 

Administration for Children and 

Families, has administrative oversight of 

the Protection and Advocacy for 

Developmental Disabilities (PADD) 

Program. Since 1986, the Department 

has provided formula grant funds to the 

same governor-designated P&A systems 

to protect and advocate for individuals 

with significant mental illness. 

SAMHSA is currently waiting for the 

ADD to issue a Notice of Proposed 

Rulemaking (NPR) for the DD Act of 

2000 amendments. These amendments 

will also govern activities fulfilled by 

the State P&A systems under the PAIMI 

Act. Therefore, to ensure to the greatest 

extent possible that all facets of the P&A 

system administered by the Department 

are subject to the same requirements, 

SAMHSA will wait until the DD Act 

NPR is published before revising the 

PAIMI Rules. [The Final PAIMI Rules 

were issued in 1997 and were extended 

in 2000 and 2004. An FRN was 

published May 2006 to extend the 

current PAIMI Rules, which will expire 

in 2007, until 2010]. 

The Substance Abuse Mental Health 

Services Administration (SAMHSA) is 

revising the PAIMI Annual Program 

Performance Report for the following 

reasons: (1) To make it consistent with 

the requirements of the annual reporting 

requirements under the PAIMI Act and 

the PAIMI Rules (42 CFR Part 51), as 2), 

and the CHA of 2000 Parts H and I; (2) 

to conform with the Office of 

Management and Budget ’s (OMB) 


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