9242 Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 

cause of any visual loss in order to 

receive disability benefits under either 

title XVI or title II, including disability 

benefits based on blindness under title 

II. The commenter indicated that these 

differences, as well as the fact that there 

is no duration requirement for benefits 

based on blindness under title XVI 

while there is such a requirement under 

title II, penalize individuals who receive 

title II disability benefits based on 

blindness. The commenter also 

recommended that if the title XVI 

eligibility requirements are statutory 

and cannot be changed, we should 

apply them when we determine whether 

individuals are disabled based on 

blindness under title II. 

Response: These rules are required by 

the Act. ‘‘Blindness’’ and ‘‘disability’’

are separate categories under title XVI, 

whereas under title II blindness is 

considered a type of ‘‘disability.’’ The 

statutory requirements for eligibility 

based on blindness under title XVI are 

different from the statutory 

requirements for eligibility based on 

disability under title II and title XVI. As 

a matter of law, we cannot apply the 

title XVI eligibility requirements for 

statutory blindness to title II claims for 

disability. 

Regulatory Procedures 

Executive Order 12866 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that these rules meet the 

requirements for a significant regulatory 

action under Executive Order 12866, as 

amended by Executive Order 13258. 

Thus, they were subject to OMB review. 

Regulatory Flexibility Act 

We certify that these rules will not 

have a significant economic impact on 

a substantial number of small entities 

because they will affect only 

individuals. Thus, a regulatory 

flexibility analysis as provided in the 

Regulatory Flexibility Act, as amended, 

is not required. 

Paperwork Reduction Act 

These rules do not impose any new or 

revised reporting or recordkeeping 

requirements on the public. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security—

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; 

96.006, Supplemental Security Income.) 

List of Subjects 

20 CFR Part 404 

Administrative practice and 

procedure, Blind, Disability benefits, 

Old-age, Survivors and Disability 

Insurance, Reporting and recordkeeping 

requirements, Social Security. 

20 CFR Part 416 

Administrative practice and 

procedure, Aged, Blind, Disability 

benefits, Public assistance programs, 

Reporting and recordkeeping 

requirements, Supplemental Security 

Income (SSI). 

Dated: November 27, 2006. 

Jo Anne B. Barnhart, 

Commissioner of Social Security. 

■ For the reasons set out in the 

preamble, we are amending subpart P of 

part 404 and subpart I of part 416 of 

chapter III of title 20 of the Code of 

Federal Regulations as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950—) 

Subpart P—[Amended] 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

Authority: Secs. 202, 205(a), (b), and (d)–

(h), 216(i), 221(a) and (i), 222(c), 223, 225, 

and 702(a)(5) of the Social Security Act (42 

U.S.C. 402, 405(a), (b), and (d)–(h), 416(i), 

421(a) and (i), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189. 

■ 2. Revise § 404.1513(a)(3) to read as 

follows: 

§ 404.1513 Medical and other evidence of 

your impairment(s). 

(a) * * * 

(3) Licensed optometrists, for 

purposes of establishing visual 

disorders only (except, in the U.S. 

Virgin Islands, licensed optometrists, for 

the measurement of visual acuity and 

visual fields only); 

* * * * * 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart I—[Amended] 

■ 3. The authority citation for subpart I 

of part 416 continues to read as follows: 

Authority: Secs. 702(a)(5), 1611, 1614, 

1619, 1631(a), (c), (d)(1), and (p), and 1633 

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

902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), 

(d)(1), and (p), and 1383(b); secs. 4(c) and 5, 

6(c)–(e), 14(a), and 15, Pub. L. 98–460, 98 

Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 

421 note, 423 note, 1382h note). 

■ 4. Revise § 416.913(a)(3) to read as 

follows: 

§ 416.913 Medical and other evidence of 

your impairment(s). 

(a) * * * 

(3) Licensed optometrists, for 

purposes of establishing visual 

disorders only (except, in the U.S. 

Virgin Islands, licensed optometrists, for 

the measurement of visual acuity and 

visual fields only). (See paragraph (f) of 

this section for the evidence needed for 

statutory blindness); 

* * * * * 

[FR Doc. E7–3577 Filed 2–28–07; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520 and 522 

New Animal Drugs; Maropitant 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of two new animal drug 

applications (NADAs) filed by Pfizer, 

Inc. The NADAs provide for the 

veterinary prescription use of 

maropitant citrate tablets and 

maropitant citrate injectable solution for 

the management of vomiting in dogs. 

DATES: This rule is effective March 1, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pfizer, 

Inc., 235 East 42d St., New York, NY 

10017, filed NADA 141–262 for 

CERENIA (maropitant citrate) Tablets. 

The NADA provides for the veterinary 

prescription use of maropitant citrate 

tablets in dogs for the prevention of 

acute vomiting and for the prevention of 

vomiting due to motion sickness. The 

application is approved as of January 

29, 2007, and 21 CFR part 520 is 

amended by adding new § 520.1315 to 

reflect the approval. 

Pfizer, Inc., also filed NADA 141–263 

for CERENIA (maropitant citrate) 

Injectable Solution, used by veterinary 

prescription in dogs for the prevention 

and treatment of acute vomiting. The 

application is approved as of January 

29, 2007, and 21 CFR part 522 is 

amended by adding new § 522.1315 to 

reflect the approval. 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 9243 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 

summaries of safety and effectiveness 

data and information submitted to 

support approval of these applications 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this 

original approval of NADA 141–262 

qualifies for 5 years of marketing 

exclusivity beginning January 29, 2007. 

Under section 512(c)(2)(F)(ii) of the 

act, this original approval of NADA 

141–263 qualifies for 3 years of 

marketing exclusivity beginning January 

29, 2007. 

The agency has determined under 21 

CFR 25.33(d)(1) that these actions are of 

a type that do not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Parts 520 and 

522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 520 and 522 are amended as 

follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Section 520.1315 is added to read 

as follows: 

§ 520.1315 Maropitant. 

(a) Specifications. Each tablet 

contains 16, 24, 60, or 160 milligrams 

(mg) maropitant as maropitant citrate. 

(b) Sponsor. See No. 000069 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Indications for use and amount. For the 

prevention of acute vomiting, 

administer a minimum of 2.0 mg per 

kilogram (/kg) body weight once daily 

for up to 5 consecutive days. For the 

prevention of vomiting due to motion 

sickness, administer a minimum of 8.0 

mg/kg body weight once daily for up to 

2 consecutive days. 

(2) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. Section 522.1315 is added to read 

as follows: 

§ 522.1315 Maropitant. 

(a) Specifications. Each milliliter of 

solution contains 10 milligrams (mg) 

maropitant as maropitant citrate. 

(b) Sponsor. See No. 000069 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer 1.0 mg per 

kilogram body weight by subcutaneous 

injection once daily for up to 5 

consecutive days. 

(2) Indications for use. For the 

prevention and treatment of acute 

vomiting. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: February 16, 2007. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. E7–3402 Filed 2–28–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; Trenbolone 

and Estradiol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental abbreviated 

new animal drug application (ANADA) 

filed by Ivy Laboratories, Division of Ivy 

Animal Health, Inc. The supplemental 

ANADA provides for the addition of 

tylosin tartrate to an approved 

subcutaneous implant containing 

trenbolone and estradiol used for 

increased rate of weight gain and 

improved feed efficiency in steers and 

heifers fed in confinement for slaughter. 

DATES: This rule is effective March 1, 

2007. 

FOR FURTHER INFORMATION CONTACT: Eric 

S. Dubbin, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0232, email: eric.dubbin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Ivy 

Laboratories, Div. of Ivy Animal Health, 

Inc., 8857 Bond St., Overland Park, KS 

66214, filed a supplement to ANADA 

200–346 for COMPONENT TE–200 with 

TYLAN (trenbolone acetate and 

estradiol with tylosin tartrate), a 

subcutaneous implant used for 

increased rate of weight gain and 

improved feed efficiency in steers and 

heifers fed in confinement for slaughter. 

The supplemental ANADA provides for 

the addition of a pellet containing 29 

milligrams (mg) tylosin tartrate to the 

approved COMPONENT TE–200 

implant for steers and heifers fed in 

confinement for slaughter. The 

supplemental application is approved as 

of January 26, 2007, and the regulations 

are amended in 21 CFR 522.2477 to 

reflect the approval. The basis of 

approval is discussed in the freedom of 

information summary. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Under section 512(c)(2)(F)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360b(c)(2)(F)(iii)), 

this approval qualifies for 3 years of 

marketing exclusivity beginning January 

26, 2007. 

The agency has determined under 21 

CFR 25.33(a)(1) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 


rwilkins on PROD1PC63 with RULES