76008 Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 

monkeys, from embarkation in the 

country of origin to release from 

quarantine. Information such as species, 

origin and intended use for monkeys, 

transit information, isolation and 

quarantine procedures, and procedures 

for testing of quarantined animals is 

necessary for CDC to make public health 

decisions. This information enables 

CDC to evaluate compliance with the 

standards and to determine whether the 

measures being taken are adequate to 

prevent exposure of persons and 

animals during importation. CDC will 

monitor at least 2 shipments to be 

assured that the provisions of a special 

permit plan are being followed by a new 

permit holder. CDC will assure that 

adequate disease control practices are 

being used by new permit holders 

before the special permit is extended to 

cover the receipt of additional 

shipments under the same plan for a 

period of 180 days, and may be renewed 

upon request. This extension eliminates 

the burden on importers to repeatedly 

report identical information, requiring 

submission only of specific shipment 

itineraries and information on changes 

to the plan which require approval. 

Respondents are businesses or not-forprofit organizations that import 

nonhuman primates. The burden 

represents full disclosure of information 

and itinerary/change information, 

respectively. There are no costs to 

respondents except for their time to 

complete the requisition process. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Instrument Respondents Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

Request for Special Permit .............. Businesses (limited permit) ............. 5 2 30/60 5 

Request for Special Permit .............. Businesses (extended permit) ......... 1 3 10/60 0 .5 

Request for Special Permit .............. Organizations (limited permit) ......... 3 2 30/60 3 

Request for Special Permit .............. Organizations (extended permit) ..... 12 2 10/60 4 

Total .......................................... .......................................................... ........................ ........................ ........................ 12 .5 

Dated: November 30, 2010. 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–30618 Filed 12–6–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0606] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Additional Listing 

Information for Medical Device 

Registration and Listing 

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 reporting and recordkeeping burden 

requirements associated with additional 

listing information for medical device 

registration and listing by nonelectronic means. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 7, 2011. 

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. 

Additional Listing Information for 

Medical Device Registration and Listing 

(OMB Control Number 0910–0387)— 

Extension 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA), 

enacted September 27, 2007, requires 

that device establishment registrations 

and listings under 21 U.S.C. 360(p) 

(including the submission of updated 

information) be submitted to the 

Secretary of Health and Human Services 

(the Secretary) by electronic means, 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76009 

unless the Secretary grants a request for 

waiver of the requirement, because the 

use of electronic means is not 

reasonable for the person requesting the 

waiver. The collections of information 

under sections 222, 223, and 224 of 

FDAAA have been approved under 

OMB control number 0910–0625. 

Registration by electronic means for 

device establishments replaced FDA 

Forms 2891 and 2891a, ‘‘Registration of 

Device Establishment,’’ and FDA Form 

2892, ‘‘Medical Device Listing,’’ with 

FDA Form 3673, ‘‘Device Registration 

and Listing Module.’’ The scope of this 

information collection addresses only 

the reporting and recordkeeping 

requirements by non-electronic means 

under § 807.31 (21 CFR 807.31). 

Under § 807.31(a) through (d), each 

owner or operator is required to 

maintain an historical file containing 

the labeling and advertisements in use 

on the date of initial listing, and in use 

after October 10, 1978, but not before 

the date of initial listing. The owner or 

operator must maintain in the historical 

file any labeling or advertisements in 

which a material change has been made 

anytime after initial listing, but may 

discard labeling and advertisements 

from the file 3 years after the date of the 

last shipment of a discontinued device 

by an owner or operator. Section 

807.31(e) requires that the owner or 

operator be prepared to submit to FDA 

copies of: (1) All device labeling, (2) all 

device labeling and representative 

advertising, or (3) only representative 

package inserts, depending upon 

whether the device is subject to the 

regulatory controls under sections 514 

and 515 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360d and 360e), or restrictions imposed 

by 21 CFR 801.109 or otherwise by 

section 520(e) of the FD&C Act. 

The information collected under these 

provisions is used by FDA to identify: 

(1) Firms subject to FDA’s regulations, 

(2) geographic distribution of firms in 

order to effectively allocate FDA’s field 

resources for inspections, and (3) the 

class of the device that determines the 

frequency of inspection. As a result, 

when complications occur with a 

particular device or component, all 

manufacturers of similar or related 

devices can easily be identified. 

The likely respondents to this 

information collection are domestic and 

foreign device establishments who must 

register and submit a device list to FDA, 

e.g., establishments engaged in the 

manufacture, preparation, propagation, 

compounding, assembly, or processing 

of medical devices intended for human 

use and commercial distribution. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency of 

response 

Total annual 

responses 

Hours per 

response Total hours 

807.31(d)(2) ......................................................................... 2,250 1 2,250 .5 1,125 

807.31(e) .............................................................................. 22,500 1 22,500 .5 11,250 

Total .............................................................................. ........................ ........................ ........................ ........................ 12,375 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

807.31(a–c) .......................................................................... 22,500 4 90,000 0.50 45,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 45,000 

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

The annual respondent reporting 

burden for device establishment 

registrations and listings for additional 

information is estimated to be 12,375 

hours and the annual respondent 

recordkeeping burden is estimated to be 

45,000 hours. Therefore, the total 

burden hours for this collection are 

estimated to be 57,375. The estimates 

cited in tables 1 and 2 of this document 

are based primarily on fiscal year 2010 

data from current systems and on 

conversations with industry and trade 

association representatives. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30582 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0088] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Electronic Products—General 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Electronic Products—General 

Requirements’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

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: In the 

Federal Register of May 13, 2010 (75 FR 

26964), the agency announced that the 

proposed information collection had 

been submitted 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. OMB has now approved the 

information collection and has assigned 


emcdonald on DSK2BSOYB1PROD with NOTICES