7270 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

2009, and include the ingredients added 

as of the date of submission. Section 

904(c) of the act also requires 

submission of information whenever 

additives, or the quantities of additives, 

are changed. 

FDA issued guidance documents on 

both (1) Registration and Product Listing 

for Owners and Operators of Domestic 

Tobacco Product Establishments 

(November 12, 2009, 74 FR 58298) and 

(2) Listing of Ingredients in Tobacco 

Products (December 1, 2009, 74 FR 

62795) to assist persons making such 

submissions to FDA under the Tobacco 

Control Act. While electronic 

submission of registration and product 

listing information and ingredient 

listing information are not required, 

FDA is strongly encouraging electronic 

submission to facilitate efficiency and 

timeliness of data management and 

collection. To that end, FDA designed 

the eSubmitter application to streamline 

the data entry process for registration 

and product listing and for ingredient 

listing. This tool allows for importation 

of large quantities of structured data, 

attachments of files (e.g., in portable 

document format (PDFs) and certain 

media files), and automatic 

acknowledgement of FDA’s receipt of 

submissions. FDA also developed paper 

forms (FDA Form 3742—Registration 

and Listing for Owners and Operators of 

Domestic Tobacco Product 

Establishments and FDA Form 3743— 

Listing of Ingredients in Tobacco 

Products) as an alternative submission 

tool. Both the eSubmitter application 

and the paper forms can be accessed at 

http://www.fda.gov/tobacco. 

On September 1, 2009 (74 FR 45219), 

FDA published notice in the Federal 

Register announcing that a proposed 

collection of information had been 

submitted to OMB for emergency 

processing under the Paperwork 

Reduction Act of 1995. On September 

15, 2009 (74 FR 47257), FDA published 

a notice correcting the length of the 

comment period, keeping it open until 

October 1, 2009. On October 13, 2009 

(74 FR 52495), FDA published a notice 

reopening the comment period until 

October 26, 2009. Based on comments 

indicating that the burden estimates 

were too low, FDA has adjusted its 

original burden estimates. FDA has 

adjusted its burden estimate for 

registration and product listing for 

owners and operators of domestic 

establishments under section 905 of the 

act from 0.75 hours per response to 3.75 

hours per response. FDA has adjusted 

its burden estimate for listing of 

ingredients under section 904 of the act 

from 0.75 hours per response to 3.0 

hours per response. FDA also decreased 

the number of respondents for listing of 

ingredients under section 904 from 

100,000 to 11,000 in response to 

comments that this estimate was too 

high. FDA also added the activity of 

applying for a Dun and Bradstreet D-UN-S number to the burden of this 

information collection for those who 

chose to use eSubmitter. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Respondents 

Hours per 

Response Total Hours 

Registration and Product 

Listing for Owners and 

Operators of Domestic 

Establishments 100,000 1 100,000 3 .75 375,000 

Listing of Ingredients 11,000 1 11,000 3 .0 33,000 

Obtaining a Dun and 

Bradstreet D-U-N-S 

Number 1,550 1 1,550 0 .5 775 

Total 112,550 112,550 408,775 

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

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3031 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0434] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Humanitarian Device Exemption 

Holders, Institutional Review Boards, 

Clinical Investigators, and Food and 

Drug Administration Staff: 

Humanitarian Device Exemption 

Regulation: Questions and Answers; 

Availability 

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 March 22, 

2010. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title Guidance for Humanitarian Device 

Exemption Holders, Institutional 

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Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7271 

Review Boards, Clinical Investigators, 

and Food and Drug Administration 

Staff: Humanitarian Device Exemption 

Regulation: Questions and Answers; 

Availability. 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, Food and Drug 

Administration, 1350 Piccard Dr., P150– 

400B, Rockville, MD 20850, 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. 

Guidance for Humanitarian Device 

Exemption Holders, Institutional 

Review Boards , Clinical Investigators, 

and Food and Drug Administration 

Staff: Humanitarian Device Exemption 

Regulation: Questions and Answers 

(OMB Control Number 0910–NEW)— 

Extension 

Title III of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law 110–85) 

amended chapter V of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 351 et seq.) by inserting section 

515A, Pediatric Uses of Devices (21 

U.S.C. 360e–1). 

This new provision requires that new 

applications under section 520(m) of the 

act (21 U.S.C. 360j(m)) include both a 

description of any pediatric 

subpopulation that suffer from: (1) A 

disease or condition that the device is 

intended to treat, diagnose, or cure and 

(2) the number of affected pediatric 

patients. 

Title III of FDAAA also amended 

section 520(m) of the act as follows: 

Section 520(m)(6)(A)(ii) provides that 

the Secretary of Health and Human 

Services will assign an annual 

distribution number (ADN) for devices 

indicated for use in a pediatric 

population or in a pediatric 

subpopulation. The ADN shall be based 

on the following information in a 

humanitarian device exemption (HDE) 

application: (1) The number of 

individuals affected by the disease or 

condition that such device is intended 

to treat, diagnose, or cure and of that 

number; (2) the number of individuals 

likely to use the device and (3) the 

number of devices reasonably necessary 

to treat such individuals. 

Section 520(m)(6)(A)(iii) provides that 

an HDE holder immediately notify the 

agency if the number of devices 

distributed during any calendar year 

exceeds the ADN. 

Section 520(m)(6)(C) provides that an 

HDE holder may petition to modify the 

ADN if additional information on the 

number of individuals affected by the 

disease or condition arises. 

In the Federal Register of August 5, 

2008 (73 FR 45460), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA had previously 

published a 30-day notice on September 

30, 2009 (74 FR 50214) and is 

republishing this 30-day notice to 

provide a more descriptive response to 

the comments received in response to 

the August 5, 2008, notice. 

FDA received 7 letters in response to 

the August 5, 2008, notice. Six of the 

seven comments were substantive, each 

containing several comments regarding 

many of the 66 questions contained in 

the guidance. The comments and the 

agency’s responses are discussed in the 

following paragraphs: 

(Comment) Several of the comments 

sought clarification regarding when the 

Annual Distribution Number (ADN) 

reporting requirement applied. 

(Response) A paragraph was added to 

clarify that the ADN relates only to 

those devices that are on the market 

through the HDE process for a disease 

or condition that occurs in pediatric 

patients or in a pediatric subpopulation. 

The response to Question 27 was 

augmented to include the phrase 

‘‘independent Institutional Review 

Board (IRB)’’ to clarify that not all IRBs 

are internal bodies within a hospital or 

clinic. 

(Comment) Question 31 was 

augmented to describe the different 

reporting requirements for 

manufacturers and for user facilities. 

(Response) Manufacturers must 

submit reports to FDA and the ‘‘IRB of 

record’’ whenever a humanitarian use 

device (HUD) may have caused or 

contributed to a death or serious injury, 

or has malfunctioned and would be 

likely to cause or contribute to a death 

or serious injury if the malfunction were 

to recur (§§ 803.50 and 814.126(a) (21 

CFR 803.50 and 814.126(a))). User 

facilities must submit reports to FDA, 

the ‘‘IRB of record’’ and the 

manufacturer whenever a HUD may 

have caused or contributed to a death. 

They must also submit reports to FDA 

and the ‘‘IRB of record’’ if the 

manufacturer is unknown, whenever a 

HUD may have caused or contributed to 

a serious injury (§§ 803.30 and 

814.126(a)). 

(Comment) Some of the comments 

related to the placement of information 

in the draft guidance. 

(Response) In Question 40, the 

statement: ‘‘If a HUD is being 

investigated in an Investigational Device 

Exemption, (IDE) Study for a different 

indication, does it impact the number of 

allowable patients under the HDE’’ was 

redesignated as question 35 and moved 

from the ‘‘IRB Section’’ of the guidance 

and placed in the section, ‘‘After FDA 

Approves an HDE’’ because it did not 

pertain directly to IRBs. 

(Comment) Changes were made to the 

section, ‘‘The Role of Institutional 

Review Boards (IRBs),’’ question 37 

specifically, in order to clarify the 

distinction between the terms ‘‘use,’’ 

‘‘HUD,’’ and ‘‘investigational use/clinical 

investigation’’ of a HUD. 

(Response) Specifically, FDA clarified 

that the term ‘‘use’’ in the guidance, 

when unmodified, refers to the use of a 

HUD according to its approved labeling 

and indication(s). If a HUD is being used 

in a clinical investigation (i.e., 

collection of safety and effectiveness 

data), whether for its HDE-approved 

indications or for a different indication, 

then this document refers to 

‘‘investigational use’’ or ‘‘clinical 

investigation’’ of the HUD. Finally in 

addition to adding clarifying 

information, a decision tree was also 

added to the guidance for ease of 

reference for IRBs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Federal 

Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Respondents 

Hours per 

Response Total Hours 

515A(a)(2) 5 1 5 100 500 

520(m)(6)(A)(ii) 3 1 3 50 150 

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7272 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Section of the Federal 

Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Respondents 

Hours per 

Response Total Hours 

520(m)(6)(A)(iii) 1 1 1 100 100 

520(m)(6)(C) 5 1 5 100 500 

Total 1,250 

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

FDA based these estimates on the 

number of original HDE applications 

that the Center for Devices and 

Radiological Health (CDRH) received for 

the period October 1, 2004, through 

September 30, 2007. During that time, 

CDRH received 16 original HDE 

applications or about 5 per year. 

FDA estimates that for each year, 

CDRH will receive five HDE 

applications and that three of these 

applications will be indicated for 

pediatric use. One HDE holder will 

notify the agency that the number of 

devices distributed in the year has 

exceeded the ADN and five HDE holders 

will petition to have the ADN modified 

due to additional information on the 

number of individuals affected by the 

disease of condition. 

The draft guidance refers also to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subparts A, B, and C, have 

been approved under OMB control 

number 0910–0231; the collection of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; and the 

collection of information requirements 

in 21 CFR 10.30 have been approved 

under OMB control number 0910–0183. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3030 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0512] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Antimicrobial 

Animal Drug Distribution Reports 

Under Section 105 of the Animal Drug 

User Fee Amendments of 2008 

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 March 22, 

2010. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Antimicrobial Animal Drug 

Distribution Reports Under Section 105 

of the Animal Drug User Fee 

Amendments of 2008.’’ 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, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 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. 

Antimicrobial Animal Drug 

Distribution Reports Under Section 105 

of the Animal Drug User Fee 

Amendments of 2008—(OMB Control 

Number 0910–NEW)—Extension 

Section 105 of the Animal Drug User 

Fee Amendments of 2008 (ADUFA) 

amended section 512 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360b) to require that the 

sponsor of each new animal drug that 

contains an antimicrobial agent submit 

an annual report to FDA on the amount 

of each antimicrobial active ingredient 

in the drug that is sold or distributed for 

use in food-producing animals, 

including information on any 

distributor-labeled product. The 

legislation was enacted to address the 

problem of antimicrobial resistance, and 

to help ensure that FDA has the 

necessary information to examine safety 

concerns related to the use of antibiotics 

in food-producing animals (154 

Congressional Record H7534). 

Each report must specify: (1) The 

amount of each antimicrobial active 

ingredient by container size, strength, 

and dosage form; (2) quantities 

distributed domestically and quantities 

exported; and (3) a listing of the target 

animals, indications, and production 

classes that are specified on the 

approved label of the product. 

The first report must be submitted not 

later than March 31, 2010. The report 

must cover the period of the preceding 

calendar year and include separate 

information for each month of the 

calendar year. The reports required 

under section 105 of ADUFA are 

required to be separate from periodic 

drug experience reports that are 

required under § 514.80(b)(4) (21 CFR 

§ 514.80(b)(4) (OMB Control No. 0910– 

0284). 

In the Federal Register of October 26, 

2009 (74FR 55046), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received comments 

from two organizations. Both 

commenters supported the information 

collection and stated that the data to be 

collected would be useful in addressing 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES