816 Federal Register / Vol. 74, No. 5 / Thursday, January 8, 2009 / Notices 

1Means both human, including biological 

products, and animal drugs. 

style than they were prior to 

participating in the training? Cross-site 

evaluation data will be collected on an 

annual basis throughout the five-year 

funding period. Pre-test and follow-up 

versions of the survey are expected to 

require approximately 10 to 15 minutes 

to complete. Estimated response time 

for the follow-up survey includes time 

for respondents to access the Web-based 

survey, complete the survey online, and 

electronically submit the survey. 

Respondents will not need to 

implement a recordkeeping system or 

compile source data in order to 

complete the survey. Where possible, 

fields in the follow-up version of the 

survey will be pre-filled with static data 

from the respondents pre-test (e.g., 

demographics, agency type) in order to 

further expedite completion of the 

survey and minimize respondent 

burden. 

Respondents: Infant Adoption 

Awareness Program Trainees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

IAATP: Trainee Survey Pre-Test Administration ............................. 1,200 1 0.15 180 

IAATP: Trainee Survey Follow-Up Administration ........................... 1,200 1 0.10 120 

Estimated Total Annual Burden 

Hours: 300. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: October 1, 2008. 

Janean Chambers, 

Reports Clearance Officer. 

Editorial Note: This document was 

received at the Office of the Federal Register 

on January 5, 2009. 

[FR Doc. E9–100 Filed 1–7–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0464] (formerly 

Docket No. 2005N–0403) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Draft Guidance for 

Industry on Providing Regulatory 

Submissions in Electronic Format— 

Drug Establishment Registration and 

Drug Listing 

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 9, 

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_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0045. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Draft Guidance for Industry on 

Providing Regulatory Submissions in 

Electronic Format—Drug Establishment 

Registration and Drug Listing; 

Availability; Registration of Producers 

of Drugs and Listing of Drugs in 

Commercial Distribution—(OMB 

Control Number 0910–0045— 

Amendment) 

Description of Respondents: 

Respondents to this collection of 

information are foreign and domestic 

owners and operators of establishments 

that engage in the manufacture, 

preparation, propagation, compounding, 

or processing (which includes, among 

other things, repackaging and 

relabeling) of a drug or drugs1 and that 

are not exempt under section 510(g) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) or subpart B of part 207 (21 

CFR part 207) (registrants). 

A. Reporting Burden 

The draft guidance describes how to 

electronically create and submit 

Structured Product Labeling (SPL) files 

using defined code sets and codes for 

establishment registration and drug 

listing information (including labeling). 

Most information is already required to 

be submitted under section 510 of the 

act, section 351 of the Public Health 

Service Act, and part 207. 

Drug establishment registration and 

drug listing information and updates to 

such information, required under part 

207, and certain additional 

recommended information are currently 

submitted in paper form using Form 

FDA 2656 (Registration of Drug 


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Federal Register / Vol. 74, No. 5 / Thursday, January 8, 2009 / Notices 817 

2 D&B® D-U-N-S® Number is a unique nine-digit 

sequence recognized as the universal standard for 

identifying and keeping track of over 100 million 

businesses worldwide. Submitting the site-specific 

D-U-N-S® Number for an entity would provide by 

reference to the number certain business 

information for that entity, e.g., address, parentage. 

Establishment/Labeler Code 

Assignment), Form FDA 2657 (Drug 

Product Listing), and Form FDA 2658 

(Registered Establishments Report of 

Private Label Distributors) (collectively 

referred to as FDA Forms; 72 FR 67733, 

November 30, 2007). 

In addition to the information 

collected by the FDA Forms (72 FR 

67733, November 30, 2007), the draft 

guidance addresses electronic 

submission of other required 

information as follows: 

• For registered foreign drug 

establishments, the name, address, and 

telephone number of its U.S. agent 

(§ 207.40(c)); 

• The name of each importer that is 

known to the establishment (the U.S. 

company or individual in the United 

States that is an owner, consignee, or 

recipient of the foreign establishment’s 

drug that is imported into the United 

States. An importer does not include the 

consumer or patient who ultimately 

purchases, receives, or is administered 

the drug, unless the foreign 

establishment ships the drug directly to 

the consumer or the patient) (section 

510(i)(1)(A) of the act); and 

• The name of each person who 

imports or offers for import (the name 

of each agent, broker, or other entity, 

other than a carrier, that the foreign 

drug establishment uses to facilitate the 

import of their drug into the United 

States) (section 510(i)(1)(A) of the act). 

FDA also is recommending the 

voluntary submission of the following 

additional information, when 

applicable: 

• To facilitate correspondence 

between foreign establishments and 

FDA, the e-mail address for the U.S. 

agent, and the telephone number(s) and 

e-mail address for the importer and 

person who imports or offers for import 

their drug; 

• A site-specific D-U-N-S® Number2

for each entity (e.g., the registrant, 

establishments, U.S. agent, importer); 

• The National Drug Code product 

code for the source drug that is repacked 

or relabeled; 

• Distinctive characteristics of certain 

listed drugs, i.e., the flavor, the color, 

and image of the actual solid dosage 

form; and 

• Registrants may indicate that they 

view as confidential the registrant’s 

business relationship with an 

establishment, or an inactive ingredient. 

In addition to the collection of 

information, there is additional burden 

for the following activities: 

• Preparing a standard operating 

procedure (SOP) for the electronic 

submission of drug establishment 

registration and drug listing 

information; 

• Creating the SPL file, including 

accessing and reviewing the technical 

specifications and instructional 

documents provided by FDA (accessible 

at http://www.fda.gov/oc/datacouncil/ 

spl.html); 

• Reviewing and selecting 

appropriate terms and codes used to 

create the SPL file (accessible at http:// 

www.fda.gov/oc/datacouncil/spl.html); 

• Obtaining the digital certificate 

used with FDA’s electronic submission 

gateway (ESG) and uploading the SPL 

file for submission (accessible at http:// 

www.fda.gov/esg/default.htm); and 

• Requests for waivers from the 

electronic submission process as 

described in the draft guidance. 

B. Burden Estimates 

Reporting Burden—The estimates for 

the number of respondents, annual 

frequency per response, and total 

annual responses indicated in table 1 of 

this document are based on our current 

estimates of the number of registrants 

and the number of submissions using 

the FDA Forms (OMB Control No. 0910– 

0045). FDA estimates that it would take 

an additional 2 hours per response (in 

addition to the estimated 2.5 hours per 

response for registering, labeler code 

requests, listing, and providing updates 

to the information approved under OMB 

Control No. 0910–0045) for the 

collection of information not currently 

submitted using the FDA Forms, and to 

create and upload the SPL file. FDA 

anticipates that the hours per response 

will decrease over time due to the 

flexibility of submitting information for 

registering multiple establishments or 

listing multiple drugs in one SPL file 

instead of submitting individual FDA 

Forms, and increasing familiarity with 

the use of the standards and code sets 

and codes for creating the SPL file. 

In certain cases, if it is unreasonable 

to expect a person to submit registration 

and listing information electronically, 

FDA may grant a waiver from the 

electronic format requirement. Because 

registrants will only need a computer 

and access to the Internet, FDA 

envisions few instances in which 

electronic submission of registration 

and listing information will not be 

reasonable for the person requesting the 

waiver and, thus, is estimating that FDA 

would grant one waiver annually. We 

estimate that a one-time burden for 

requesting a waiver would be an hour of 

time for a mid-level manager to draft, 

approve, and mail a letter. 

Recordkeeping Burden—In table 2 of 

this document, FDA estimates that 3,295 

(39 + 3,256) respondents would expend 

a one-time burden of approximately 40 

hours in preparing, reviewing, and 

approving an SOP for creating and 

uploading the SPL file; and an estimated 

1 hour annually to maintain the SOP as 

needed. 

In the Federal Register of July 11, 

2008 (73 FR 39964), FDA published a 

notice of availability of the draft 

guidance document providing a 60-day 

public comment period on the 

information collection provisions. 

Nineteen comments were received of 

which four remarked on the information 

collection. Thereafter, in the Federal 

Register of October 23, 2008 (73 FR 

63158), FDA published a 30-day notice 

responding to the comments submitted 

on the proposed collection of 

information and announced that the 

proposed collection of information had 

been submitted to OMB. In response to 

a request by OMB, FDA is republishing 

the 30-day notice responding to 

comments and announcing the 

submission of the proposed collection of 

information to OMB. 

(Comment 1) On the topic whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have a practical 

utility, one comment agreed that the 

proposed collection of information is 

necessary for us to perform its functions 

and is consistent with the provisions of 

the Food and Drug Administration 

Amendments Act of 2007 (Public Law 

110–85). The comment continued to say 

that the information is also necessary to 

support the transition from paper format 

to electronic format, and that the 

additional information requested by us 

is logical and reasonable and is not an 

undue burden. 

(Response) We appreciate the support 

and concurrence of the comment. 

(Comment 2) On the topic whether 

the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used, 

one comment stated that we 

underestimated the effort to prepare, 

review, approve, implement and 

maintain internal SOPs for electronic 

submission of drug establishment 

registration and drug listing information 

because of the following reason. 

Particularly for most large companies, 

drug establishment registration and drug 

listing information (currently submitted 

in paper format under 21 CFR 207.22) 


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818 Federal Register / Vol. 74, No. 5 / Thursday, January 8, 2009 / Notices 

and content of labeling (currently 

submitted in electronic format under 21 

CFR 314.50(l)(1)(i)) are handled by 

completely different functional experts 

and/or departments in the companies. 

To coordinate these processes, 

additional time is needed to define new 

procedures and interactions that cross 

functional departments and possibly 

international groups. Therefore, large 

companies will expend more than 40 

hours to prepare, review, approve, 

implement and maintain SOPs. 

Another comment asserts that the 

hours per response in table 1 are 

underestimated if the estimate accounts 

for the time required to become familiar 

with the Structured Product Labeling 

(SPL) standard. 

(Response) In estimating hours per 

record in table 2 of this document, we 

considered the various sizes of entities 

affected and proposed an average 

number of hours per activity. For 

example, the estimated 40 hours per 

record are based on smaller entities 

requiring approximately 20 hours per 

record and larger entities requiring 

approximately 60 hours per record. 

Therefore, because the comment did not 

provide a revised estimate, we are 

maintaining an estimate of 40 hours per 

record, which is consistent with 

preparing SOPs for paper format 

submissions and also includes 

coordination efforts. 

Regarding the comment on 

underestimating the hours per response 

in table 1, the software designed to 

create the SPL files, the step-by-step 

instructions in the technical guides, and 

our technical assistance email address 

are provided by us for the purpose of 

minimizing the need to learn the SPL 

standard before submitting information 

electronically. 

In this document, we are correcting an 

error in table 1 under the hours per 

response column. Although the written 

description of the burden added 2 hours 

to the existing 2.5 hours approved by 

OMB under Control Number 0910–0045 

(for a total of 4.5 hours), 4.5 hours was 

not correctly reproduced in table 1. The 

total hours column is also adjusted to 

reflect this correction. 

(Comment 3) On the topic of ways to 

minimize the burden of the collection 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology, one comment 

encouraged us to continue the 

availability of Xforms at no cost for 

industry to use as a software tool for the 

creation of SPL. The comment also 

requested that we continue this practice 

as technology evolves and provide 

support for this tool. 

(Response) We appreciate the 

encouragement of the comment and will 

consider the request to continue the 

practice and provide support as 

technology evolves. 

(Comment 4) Two comments did not 

agree with our statement that there are 

no capital or operating and maintenance 

costs associated with the collection of 

information. The comments explained 

that some companies may choose 

alternative tools to the Xform software 

or work with external conversion 

providers, which may involve the 

purchase and maintenance of software 

plus the use of internal information 

technology personnel for installation, 

configuration and maintenance. These 

comments further stated that these costs 

are significant and need to be 

considered in the overall cost for 

industry to comply with the electronic 

submission requirement. 

(Response) As the comments stated, 

companies may choose to use 

alternative tools or work with external 

conversion providers. We do not 

disagree. However, we have made every 

effort to eliminate costs to industry to 

comply with the statutory requirement 

to electronically submit drug 

establishment registration and drug 

listing information. 

We also received comments that were 

specifically related to the technical 

documents referenced in the draft 

guidance. Although these comments are 

not directly related to the draft guidance 

document that contains the information 

collection, we will consider the 

comments when reviewing the technical 

documents for revision. 

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 

Responses 

Hours per 

Response Total Hours 

New registrations, including new labeler code requests 39 14.72 574 4.5 2,583 

Annual updates of registration information 3,256 2.99 9,735 4.5 43,807 .5 

New drug listings 1,567 6.57 10,295 4.5 46,327 .5 

New listings for private label distributors 146 10.06 1,469 4.5 6,610 .5 

June and December updates of all 

drug listing information 1,677 11.21 18,799 4.5 84,595 .5 

Waiver requests 1 1 1 1 1 

Total 183,924 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity No. of Recordkeepers Annual Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

One-time preparation of SOP 3,295 1 3,295 40 131,800 


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3See http://www.fda.gov/oc/datacouncil/ 

xforms.html. 

4See http://www.fda.gov/oc/datacouncil/ 

spl.html. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

Activity No. of Recordkeepers Annual Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

SOP maintenance 3,295 1 3,295 1 3,295 

Total 135,095 

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

C. Costs Associated With Electronic 

Submission 

There are no capital costs or operating 

and maintenance costs associated with 

the transition from paper to electronic 

submissions. To create an SPL file and 

submit it to FDA, a registrant would 

need the following tools: A computer, 

appropriate software, access to the 

Internet, knowledge of terminology and 

standards, and access to FDA’s ESG. 

Registrants (and most individuals) 

have computers and Internet access 

available for their use. If a business does 

not have an available computer or 

access to the Internet, free use of 

computers and Internet are usually 

available at public facilities, e.g., a 

community library; or they may request 

a waiver from submitting the 

information electronically. Software is 

necessary to create a ‘‘document.’’ The 

SPL file or ‘‘document’’ may be created 

internally by a business with experience 

with SPL, or a business may use a userfriendly software (XForms)3 available at 

no cost for industry use. In addition to 

the software, FDA also provides 

technical assistance, and other 

resources, code sets and codes, and data 

standards regarding SPL files.4

Once the SPL file is created, the 

registrant would upload the file through 

the ESG. A digital certificate is needed 

to use the ESG. The digital certificate 

binds together the owner’s name and a 

pair of electronic keys (a public key and 

a private key) that can be used to 

encrypt and sign documents. However, 

a small fee of up to $20.00 is charged 

for the digital certificate and the 

registrant may need to renew the 

certificate not less than annually. FDA 

is not calculating this small fee as cost 

of doing business because it is less than 

or equal to the biannual courier costs 

the registrant incurs for paper 

submissions. 

Dated: December 22, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–108 Filed 1–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

[Funding Announcement Number: HHS– 

2009–IHS–NIHB–0001] 

Office of Tribal Program; 

Announcement Type: Competing 

Continuation 

Catalog of Federal Domestic Assistance 

Numbers (s): 93.933 

Key Dates: Application Deadline Date: 

January 9, 2009 

Review Date: January 16, 2009 

Results Notification: January 21, 2009 

Earliest Anticipated Start Date: 

February 1, 2009 

I. Funding Opportunity Description 

Authority: The Indian Health Service (IHS) 

announces that a Single Source cooperative 

agreement is open for receipt of an 

application from the National Indian Health 

Board. This program is authorized under 

Public Health Service Act, 42 U.S.C. 301. 

This program is described at 93.933 in the 

Catalog of Federal Domestic Assistance 

(CFDA). Purpose: The Office of Tribal 

Programs (OTP) has designated funds for the 

Single Source National Indian Health Board 

(NIHB) to further health program objectives 

in the American Indian/Alaska Native (AI/ 

AN) community with outreach and education 

efforts in the interest of improving Indian 

health care. The NIHB is the only national 

Indian organization with expertise on the 

variety of issues related to the provision of 

health care to Indian people. 

The NIHB represents all 562– 

Federally recognized tribes: including 

Tribal governments operating their own 

health care delivery systems through 

self-determination agreements with the 

IHS and tribes that continue to receive 

health care directly from the IHS. The 

NIHB is governed by twelve elected 

Tribal Government Officials who 

represent each of the twelve IHS Areas 

and the HHS regions where Federally 

recognized Tribes exist. The NIHB is the 

only national organization with an 

expertise in health policy and health 

programs, and the only national 

organization with the designated 

authority to represent all AI/AN tribes 

and villages. The NIHB has a national 

constituency and clearly supports 

critical services and activities within the 

IHS mission of quality health care for 

AI/AN people. The NIHB provides 

policy analysis and development, 

program assessment and development, 

regional and national meeting 

coordination, consultation and health 

care advocacy to IHS and HHS based on 

tribal input through a broad based 

consumer network. Furthermore, the 

NIHB also provides planning and 

technical assistance to Tribes, Area 

Health Boards, and other Tribal 

organizations through the cooperative 

agreement with the IHS. 

II. Award Information 

Type of Award: Cooperative 

Agreement. A cooperative agreement 

will be awarded as the OTP staff will 

have substantial programmatic 

involvement with the recipient in 

carrying out the project as noted in the 

following delineated roles of 

involvement to further IHS’ health 

program objectives in the AI/AN 

community with outreach and 

education efforts in the interest of 

improving Indian health care. 

Cooperative Agreement—Involvement 

of Parties 

This project is a cooperative 

agreement between the IHS and the 

NIHB. 

Selected entity is responsible for the 

following: 

1. To provide technical advice in the 

area of health care policy analysis and 

program development on which IHS 

needs to take action; 

2. To provide consultation that is 

representative of all Tribal governments 

in the area of health care policy analysis 

and program development; 

3. To assure that health care advocacy 

is based on Tribal input through a broad 

based consumer network involving the 

Area Indian Health Boards or Health 


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