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
14022 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0626. The 

approval expires on February 28, 2015. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: March 2, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5632 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–D–0112] 

Guidance for Industry on Chemistry, 

Manufacturing, and Controls 

Information—Fermentation-Derived 

Intermediates, Drug Substances, and 

Related Drug Products for Veterinary 

Medicinal Use; 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 

#216 entitled ‘‘Chemistry, 

Manufacturing, and Controls (CMC) 

Information—Fermentation-Derived 

Intermediates, Drug Substances, and 

Related Drug Products for Veterinary 

Medicinal Use.’’ 

The purpose of this document is to 

provide recommendations on what 

documentation to submit to support the 

CMC information for fermentationderived intermediates, drug substances, 

and related drug products for veterinary 

medicinal use. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Popek, Center for Veterinary 

Medicine (HFV–144), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8269, 

email: michael.popek@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 14, 

2011 (76 FR 13629), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Chemistry, Manufacturing, 

and Controls (CMC) Information— 

Fermentation-Derived Intermediates, 

Drug Substances, and Related Drug 

Products for Veterinary Medicinal Use’’ 

giving interested persons until May 30, 

2011, to comment on the draft guidance. 

FDA received one comment on the draft 

guidance. No substantive changes were 

made in finalizing this guidance 

document. 

The guidance announced in this 

notice finalizes the draft guidance dated 

March 14, 2012. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance will represent the 

Agency’s current thinking on this topic. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

this guidance have been approved under 

OMB control number 0910–0032. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5629 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–D–0091] 

Guidance for Industry: Testing for 

Salmonella Species in Human Foods 

and Direct-Human-Contact Animal 

Foods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a 

guidance entitled ‘‘Guidance for 

Industry: Testing for Salmonella Species 

in Human Foods and Direct-HumanContact Animal Foods.’’ The document 

provides guidance to firms that 

manufacture, process, pack, or hold 

human foods or direct-human-contact 

animal foods intended for distribution 

to consumers, institutions, or food 

processors. This guidance does not 

apply to egg producers and other 

persons who are covered by FDA’s final 

rule ‘‘Prevention of Salmonella 

Enteritidis in Shell Eggs During 

Production, Storage, and 

Transportation.’’ The guidance 

addresses testing procedures for 

Salmonella species (spp.) in human 

foods (except shell eggs) and directhuman-contact animal foods, and the 

interpretation of test results, when the 

presence of Salmonella spp. in the food 

may render the food injurious to human 

health. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Food Safety, Center for Food 

Safety and Applied Nutrition, (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740. Send two self-addressed 

adhesive labels to assist that office in 

processing your request. See the 


wreier-aviles on DSK5TPTVN1PROD with NOTICES