14138 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 

TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued 

21 CFR Section Number of 

recordkeepers 

First year 

frequency of 

recordkeeping 

Total 

records 

Hours per 

record 

Total 

hours 

14 ...................... Controls to Prevent Adulteration From Microorganisms 106.55(d), 106.100(e)(5)(ii), and 

106.100(f)(7).

3 52 156 0.25 39 

15 ...................... Controls to Prevent Adulteration During Packaging 

and Labeling of Infant Formula 106.60(c).

1 12 12 0.25 3 

16 ...................... General Quality Control—Testing 106.91(b)(1), 

106.91(b)(2) and 106.91(b)(3).

2 1 2 2 4 

17 ...................... General Quality Control 106.91(b)(1), 106.91(d), 

and 106.100(e)(5)(i).

2 52 104 0.15 15.6 

18 ...................... General Quality Control 106.91(b)(2) 106.91(d), 

and 106.100(e)(5)(i).

2 52 104 0.15 15.6 

19 ...................... General Quality Control 106.91(b)(3) 106.91(d), 

and 106.100(e)(5)(i).

2 52 104 0.15 15.6 

20 ...................... Audit Plans and Procedures 106.94—Ongoing review and updating of Audits.3 1 3 8 24 

21 ...................... Audit Plans and Procedures 106.94—Regular Audits.3 52 156 4 624 

Total Recurring Recordkeeping Burden ................... .......................... .......................... ................ ................ 6,328.06 

Total Recordkeeping Burden ................................... .......................... .......................... ................ ................ 25,648.06 

1As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total 

hours column reflects the total number of hours averaged over the 4-year period. 2As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total 

hours column reflects the total number of hours averaged over the 4-year period. 

III. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Zink, Don. Statement of Donald L. Zink, 

Ph.D.: Infant Formula Manufacturing 

Practices, 2013. 

Dated: March 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06117 Filed 3–17–15; 8:45 am] 

BILLING CODE 4164–01–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 18, 2015. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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, 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14139 

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 

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 decision-making by the 

Department of Health and Human 

Services 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 decision making 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 follow-up 

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

Activity/FD&C act section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Emergency Shortages Data Collection System (903(d)(2)) .................... 125 3 375 0.5 188 

1There 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 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06118 Filed 3–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Cardiovascular and Renal Drugs 

Advisory Committee; Amendment of 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of meeting of 

the Cardiovascular and Renal Drugs 

Advisory Committee. This meeting was 

mstockstill on DSK4VPTVN1PROD with NOTICES