Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61451 

3Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 

4Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

606.100(b)2 2495 1 249 24 5,976 

606.100(c) 2495 10 2,490 1 2,490 

606.110(a)3 396 1 39 0 .5 20 

606.151(e) 2495 12 2,988 0 .083 248 

606.1604 2495 1,928 480,000 0 .75 360,000 

606.160(b)(1)(ix) 1,709 1,024 1,750,000 0 .05 87,500 

606.160(b)(1)(xi) 1,628 4 6,750 0 .05 338 

606.165 2495 1,928 480,000 0 .083 39,840 

606.170(a) 2495 12 2,988 1 2,988 

610.40(g)(1) 1,628 1 1,628 0 .5 814 

Total 500,214 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b). 3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included 

in the estimate for § 606.110(a). 4The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and 

(c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the 

maintenance of various records are included in the estimate for § 606.160. 5Five percent of CMS transfusion services and FDA-registered blood establishments (0.05 X 4,980). 

6Five percent of plateletpheresis and leukopheresis establishments (0.05 X 773). 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21153 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0283] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Waivers of In Vivo 

Demonstration of Bioequivalence of 

Animal Drugs in Soluble Powder Oral 

Dosage Form Products and Type A 

Medicated Articles 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by November 

23, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Waivers of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles 

The generic Animal Drug and Patent 

Term Registration Act of 1988 permitted 

generic drug manufacturers to copy 

those pioneer drug products that were 

no longer subject to patent or other 

marketing exclusivity protection. The 

approval for marketing these generic 

products is based in part upon a 

demonstration of bioequivalence 

between the generic product and 

pioneer product. This guidance clarifies 

circumstances under which FDA 

believes the demonstration of 

bioequivalence by the stature does not 

need to be established on the basis of in 

vivo studies for soluble powder oral 

dosage form products and Type A 

medicated articles. The data submitted 

in support of the waiver request are 

necessary to validate the waiver 

decision. 

The requirement to establish 

bioequivalence through in vivo studies 

(blood level bioequivalence or clinical 

endpoint bioequivalence) may be 

waived for soluble powder or Type A 

medicated articles in either of two 

61452 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

alternative ways. A biowaiver may be 

granted if it can be shown that the 

generic soluble powder oral dosage form 

product or Type A medicated article 

contains the same active and inactive 

ingredient(s) and is using the same 

manufacturing processes as the 

approved comparator product or article. 

Alternatively, a biowaiver may be 

granted without direct comparison to 

the pioneer product‘s formulation and 

manufacturing process if it can be 

shown that the active pharmaceutical 

ingredient(s), is the same as the pioneer 

product, is soluble , and that there are 

no ingredients in the formulation likely 

to cause adverse pharmacologic effects. 

For the purpose of evaluating soluble 

powder oral dosage form products and 

Type A medicated articles, solubility 

can be demonstrated in two ways: ‘‘USP 

definition’’ approach or ‘‘Dosage 

Adjusted’’ approach. 

In the Federal Register of August 3, 

2004 (69 FR 46553), the agency 

requested comments on this collection 

of information. In response to that 

notice, the agency received several 

comments on the guidance, two from 

individuals who were generally 

favorable and one from the Animal 

Health Institute (AHI), which was 

supportive of some aspects of the 

proposed guidance and not supportive 

of others. None of the comments 

received took issue with any aspect of 

the paperwork burden associated with 

the draft policy. The Center for 

Veterinary Medicine has revised the 

substance of the proposed guidance in 

several respects in response to AHI 

comments. 

The respondents for this collection of 

information are pharmaceutical 

companies manufacturing animal drugs. 

FDA estimates the burden for this 

collection of information as follows in 

tables 1 and 2 of this document. The 

source of the data is records of generic 

drug applications over the past 10 years. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS1

No. of Respondents Annual Frequency per 

Responses 

Total Annual Responses Hours per Response Total Hours 

Same Formulation / Manufacturing Process Approach 1 1 1 5 5 

Same API / Solubility Approach 5 5 5 10 50 

Total Burden Hours 55 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES1

No. of Respondents Annual Frequency per 

Responses 

Total Annual Responses Hourse per Response Total Hours 

Same Formulation / Manufacturing Process Approach. 2 2 2 5 10 

Same API / Solubility Approach 10 10 10 20 200 

Total Burden Hours 210 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21154 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0209] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; Food 

Contact Substances Notification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

23, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA 250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Contact Substances Notification 

System—21 CFR 170.101 and 170.106—

(OMB Control Number 0910–0495)—

Extension 

Section 409(h) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 348(h)) establishes a premarket 

notification process for food contact 

substances. Section 409(h)(6) of the act 

defines a ‘‘food contact substance’’ as 

‘‘any substance intended for use as a 

component of materials used in 

manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food.’’ Section 409(h)(3) of 

the act requires that the notification 

process be used for authorizing the 

marketing of food contact substances