2598 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 

EXHIBIT 3—ESTIMATED COST—Continued 

Cost component Total cost Annualized 

cost 

Data Processing and Analysis ................................................................................................................................. 70,569 47,046 

Publication of Results .............................................................................................................................................. 41,420 27,613 

Project Management ................................................................................................................................................ 68,908 45,939 

Overhead ................................................................................................................................................................. 76,320 50,880 

Total .................................................................................................................................................................. 399,961 266,641 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) 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 upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: December 30, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–537 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0543] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Waiver 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. 

DATES: Fax written comments on the 

collection of information by February 

17, 2009. 

ADDRESSES: 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: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submissions@OMB.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0575. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr.,Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Waiver of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles—21 CFR Part 514 (OMB 

Control Number 0910–0575)—Extension 

The Center for Veterinary Medicine 

has written this guidance to address a 

perceived need for agency guidance in 

its work with the animal health 

industry. This guidance describes the 

procedures that the agency recommends 

for the review of requests for waiver of 

in vivo demonstration of bioequivalence 

for generic soluble powder oral dosage 

form products and Type A medicated 

articles. 

The Generic Animal Drug and Patent 

Term Registration Act of 1988 permitted 

the 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 the 

pioneer product. This guidance clarifies 

circumstances under which FDA 

believes the demonstration of 

bioequivalence required by the statute 

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 oral dosage 

form products or Type A medicated 

articles in either of two 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 produced 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) (API) 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 one of two ways: (1) 

‘‘USP definition’’ approach or (2) 

‘‘Dosage adjusted’’ approach. 

In the Federal Register of October 29, 

2008 (73 FR 64338), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 2599 

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

No. of 

Respondents 

Annual Frequency 

per Response 

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 

of Responses 

Total Annual 

Responses 

Hours 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. 

The sources of the previous data are 

records of generic drug applications 

over the past 10 years. 

Dated: January 8, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–782 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0202] (formerly 

Docket No. 2007D–0106) 

Guidance for Clinical Investigators, 

Sponsors, and Institutional Review 

Boards on Adverse Event Reporting— 

Improving Human Subject Protection; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Adverse Event Reporting— 

Improving Human Subject Protection.’’ 

This guidance is intended to assist the 

research community in interpreting 

requirements for submitting reports of 

unanticipated problems, including 

certain adverse events reports, to 

institutional review boards (IRBs). FDA 

developed this guidance in response to 

concerns raised by the IRB community 

that increasingly large volumes of 

individual, unanalyzed adverse event 

reports are inhibiting, rather than 

enhancing, the ability of IRBs to 

adequately protect human subjects. The 

guidance provides recommendations to 

IRBs, sponsors, and investigators on 

improving the usefulness of the adverse 

event information submitted to IRBs. 

Elsewhere in this issue of the Federal 

Register, FDA is issuing the final rule 

entitled ‘‘Institutional Review Boards; 

Registration Requirements.’’ 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Griffin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–2270, e-mail: 

Joseph.Griffin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for clinical investigators, 

sponsors, and IRBs entitled ‘‘Adverse 

Event Reporting—Improving Human 

Subject Protection.’’ Under the 

regulations in 21 CFR part 50 

(Protection of Human Subjects), part 56 

(21 CFR part 56) (Institutional Review 

Boards), part 312 (21 CFR part 312) 

(Investigational New Drug Application), 

and part 812 (21 CFR part 812) 

(Investigational Device Exemptions), an 

IRB must review and approve a clinical 

study before the study is initiated. 

Additionally, after an IRB’s initial 

review and approval, an IRB must 

conduct continuing review of the study 

at intervals appropriate to the degree of 

risk presented by the study, at least 

annually. The primary purpose of both 

the initial review of a study and the 

periodic review of the conduct of the 

study is to ensure the protection of the 

rights and welfare of human subjects. To 

do its job, an IRB must be informed of 

any unanticipated problems in the study 

and any changes in the research activity. 

This guidance discusses adverse event 

reporting to IRBs by sponsors and 

investigators and emphasizes the value 

of well-analyzed adverse event data to 

an IRB review. 

A notice announcing the draft version 

of this guidance published in the 

Federal Register on April 9, 2007 (72 FR 

17562). After carefully considering all 

received comments, the agency is 

finalizing that guidance. The draft and 

the final have relatively minor 

substantive differences. The 

recommendations section in the final 


jlentini on PROD1PC65 with NOTICES