14020 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 

submission of the information by the 

public and stakeholders does not 

guarantee that an investigation against a 

retailer will be triggered, and FDA will 

work to ensure that no specific retailer 

or supplier is unfairly targeted. 

To clarify that Form FDA 3779 is not 

an inspection report, FDA is amending 

the title of Form FDA 3779 to ‘‘Potential 

Tobacco Product Violations Reporting.’’ 

FDA is making this change to reflect 

that the form is voluntary, that the form 

is intended to be a means for the public 

to submit information to FDA regarding 

possible violations of the laws that it 

enforces, and that a Form FDA 3779 

submission is not, by itself, enough to 

warrant further FDA action. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity and Form FDA 3779 Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Reporting potential violations of the FD&C Act, as amended by the Tobacco Control Act, by telephone, Internet or 

paper form, smartphone application or email .................. 1,000 1 1,000 0.25 250 

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

FDA estimates that submitting the 

information (by phone, Internet form, 

paper form by mail, smartphone 

application, or email) will take 15 

minutes per response. Since a similar 

type of reporting went into effect for the 

cigarette flavor ban, FDA has received 

several reports via the Internet or email. 

Based on the rate of reporting for the 

cigarette flavor ban, reports received 

from FDA’s toll-free telephone number 

and email address, and FDA experience, 

FDA estimates the number of annual 

respondents to this collection of 

information will be 1,000, who will 

each submit 1 report by phone, Internet 

form, paper form, smartphone 

application, or email. Each report is 

expected to take 15 minutes to complete 

and submit, therefore, total burden 

hours for this collection of information 

is estimated to be 250 hours (1,000 

responses × 0.25 hours per response). 

Because of the variety of products 

regulated by FDA under the authority of 

the FD&C Act, as amended by the 

Tobacco Control Act, FDA expects the 

rate of calls and reports received to 

remain constant over the next 3 years. 

Dated: March 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5634 Filed 3–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0197] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Emergency 

Shortages Data Collection System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the Emergency Shortages Data 

Collection System. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 7, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Emergency Shortages Data Collection 

System—Section 903(d)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(OMB Control Number 0910–0491)— 

Extension 

Under section 903(d)(2) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 393(d)(2)), the 

Commissioner of Food and Drugs is 

authorized to implement general powers 

(including conducting research) to carry 

out effectively the mission of FDA. 

Subsequent to the events of September 

11, 2001, and as part of broader 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 14021 

counterterrorism and emergency 

preparedness activities, FDA’s Center 

for Devices and Radiological Health 

(CDRH) began developing operational 

plans and interventions that would 

enable CDRH to anticipate and respond 

to medical device shortages that might 

arise in the context of Federally 

declared disasters/emergencies or 

regulatory actions. In particular, CDRH 

identified the need to acquire and 

maintain detailed data on domestic 

inventory, manufacturing capabilities, 

distribution plans, and raw material 

constraints for medical devices that 

would be in high demand, and/or would 

be vulnerable to shortages in specific 

disaster/emergency situations or 

following specific regulatory actions. 

Such data could support prospective 

risk assessment, help inform risk 

mitigation strategies, and support realtime decisionmaking by HHS during 

actual emergencies or emergency 

preparedness exercises. 

FDA developed ‘‘The Emergency 

Medical Device Shortages Program 

Survey’’ in 2002 to support the 

acquisition of such data from medical 

device manufacturers. In 2004, CDRH 

changed the process for the data 

collection, and the electronic database 

in which the data were stored was 

formally renamed the ‘‘Emergency 

Shortages Data Collection System’’ 

(ESDCS). Recognizing that some of the 

data collected may be commercially 

confidential, access to the ESDCS is 

restricted to members of the CDRH 

Emergency Shortage Team (EST) and 

senior management with a need-toknow. At this time, the need-to-know 

senior management personnel are 

limited to two senior managers. Further, 

the data are used by this defined group 

only for decisionmaking and planning 

in the context of a Federally declared 

disaster/emergency, an official 

emergency preparedness exercise, or a 

potential public health risk posed by 

non-disaster-related device shortage. 

The data procurement process 

consists of an initial scripted telephone 

call to a regulatory officer at a registered 

manufacturer of one or more key 

medical devices tracked in the ESDCS. 

In this initial call, the EST member 

describes the intent and goals of the 

data collection effort and makes the 

specific data request. After the initial 

call, one or more additional followup 

calls and/or electronic mail 

correspondence may be required to 

verify/validate data sent from the 

manufacturer, confirm receipt, and/or 

request additional detail. Although the 

regulatory officer is the agent who the 

EST member initially contacts, 

regulatory officers may designate an 

alternate representative within their 

organization to correspond subsequently 

with the CDRH EST member who is 

collecting or verifying/validating the 

data. 

Because of the dynamic nature of the 

medical device industry, particularly 

with respect to specific product lines, 

manufacturing capabilities, and raw 

material/subcomponent sourcing, it is 

necessary to update the data in the 

ESDCS at regular intervals. The EST 

makes such updates on a regular basis, 

but makes efforts to limit the frequency 

of outreach to a specific manufacturer to 

no more than every 4 months. 

The ESDCS will only include those 

medical devices for which there will 

likely be high demand during a specific 

emergency/disaster, or for which there 

are sufficiently small numbers of 

manufacturers such that disruption of 

manufacture or loss of one or more of 

these manufacturers would create a 

shortage. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of the FD&C Act Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total hours 

903(d)(2) .............................................................................. 125 3 375 0.5 188 

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

FDA based the burden estimates in 

table 1 of this document on past 

experience with direct contact with the 

medical device manufacturers and 

anticipated changes in the medical 

device manufacturing patterns for the 

specific devices being monitored. FDA 

estimates that approximately 125 

manufacturers would be contacted by 

telephone and/or electronic mail 3 times 

per year either to obtain primary data or 

to verify/validate data. Because the 

requested data represent data elements 

that are monitored or tracked by 

manufacturers as part of routine 

inventory management activities, it is 

anticipated that for most manufacturers, 

the estimated time required of 

manufacturers to complete the data 

request will not exceed 30 minutes per 

request cycle. 

Dated: March 2, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5633 Filed 3–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0403] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Substantiation for Dietary Supplement 

Claims Made Under the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Substantiation for Dietary Supplement 

Claims Made Under the Federal Food, 

Drug, and Cosmetic Act’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, II, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: On August 

30, 2011, the Agency submitted a 

proposed collection of information 

entitled ’’ Substantiation for Dietary 

Supplement Claims Made Under the 

Federal Food, Drug, and Cosmetic Act’’ 

to OMB for review and clearance under 

44 U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES