Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices 69447 

Estimated Total Annual Burden 

Hours: 51,845.88 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: November 8, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–28447 Filed 11–10–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Community-Based Family 

Resource and Support Grants (Name 

changed to Child Abuse Prevention 

Program—OIS notified 6/2007). 

OMB No.: 0970–0155. 

Description: The Program Instruction, 

prepared in response to the enactment 

of the Community-Based Grants for the 

Prevention of Child Abuse and Neglect 

(administratively known as the 

Community Based Child Abuse 

Prevention Program, (CBCAP), as set 

forth in Title II of Public Law 108–36, 

Child Abuse Prevention and Treatment 

Act Amendments of 2003, and in the 

process of reauthorization, provides 

direction to the States and Territories to 

accomplish the purposes of (1) 

supporting community-based efforts to 

develop, operate, expand, and where 

appropriate to network, initiatives 

aimed at the prevention of child abuse 

and neglect, and to support networks of 

coordinated resources and activities to 

better strengthen and support families to 

reduce the likelihood of child abuse and 

neglect, and; (2) fostering an 

understanding, appreciation, and 

knowledge of diverse populations in 

order to be effective in preventing and 

treating child abuse and neglect. This 

Program Instruction contains 

information collection requirements that 

are found in (Pub. L. 108–36) at sections 

201; 202; 203; 205; 206; 207; and 

pursuant to receiving a grant award. The 

information submitted will be used by 

the agency to ensure compliance with 

the statute, complete the calculation of 

the grant award entitlement, and 

provide training and technical 

assistance to the grantee. 

Respondents: State Governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Application ....................................................................................................... 52 1 40 2,080

Annual Report .................................................................................................. 52 1 24 1,248 

Estimated Total Annual Burden 

Hours: 3,328. 

In compliance with the requirements 

of section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: November 8, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–28445 Filed 11–10–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0555] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Device Tracking 

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 

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69448 Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices 

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 

information collection requirements for 

the tracking of medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 11, 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. 

In preparing this notice, the agency 

reviewed a comment that was posted in 

response to the 60-day notice of 

February 5, 2008 (73 FR 6729) (Docket 

No. FDA–2008–N–0050). FDA 

transitioned to the Federal Dockets 

Management System (FDMS) in January 

2008, and this comment was not posted 

to the docket until after the closing of 

the comment period. The comment 

responded to item 1 (whether the 

information collection is necessary) and 

item 3 (how to enhance quality of ICR). 

With regard to item 1, the comment 

emphasized the importance of medical 

device tracking and supported the 

information collection request in full. 

With regard to item 3, the comment said 

that implementing the unique device 

identification provision (UDI) of the 

Food and Drug Administration 

Modernization Act (FDAMA) would go 

a long way in enhancing medical device 

tracking, and the agency is currently 

undertaking this effort. 

Medical Devices; Device Tracking—21 

CFR Part 821 (OMB Control Number 

0910–0442)—Extension 

Section 211 of the Food and Drug 

Administration Modernization Act 

(FDAMA) (Pub. L. 105–115) became 

effective on February 19, 1998. FDAMA 

amended the previous medical device 

tracking provisions under section 

519(e)(1) and (e)(2) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i(e)(1) and (e)(2)) and were 

added by the Safe Medical Devices Act 

of 1990 (SMDA) (Pub. L. 101–629). 

Unlike the tracking provisions under 

SMDA which required tracking of any 

medical device meeting certain criteria, 

FDAMA allows FDA discretion in 

applying tracking provisions to medical 

devices meeting certain criteria, and 

provides that tracking requirements for 

medical devices can be imposed only 

after FDA issues an order. In the Federal 

Register of February 8, 2002 (67 FR 

5943), FDA issued a final rule which 

conformed existing tracking regulations 

to changes in tracking provisions 

effected by FDAMA under part 821 (21 

CFR part 821). 

Section 519(e)(1) of the act, as 

amended by FDAMA, provides that 

FDA may require by order, that a 

manufacturer adopt a method for 

tracking a class II or III medical device, 

if the device meets one of the three 

following criteria: (1) The failure of the 

device would be reasonably likely to 

have serious adverse health 

consequences, (2) the device is intended 

to be implanted in the human body for 

more than 1 year (referred to as a 

‘‘tracked implant’’), or (3) the device is 

life-sustaining or life-supporting 

(referred to as a ‘‘tracked l/s-l/s device’’) 

and is used outside a device user 

facility. 

Tracked device information is 

collected to facilitate identifying the 

current location of medical devices and 

patients possessing those devices, to the 

extent that patients permit the 

collection of identifying information. 

Manufacturers and FDA (where 

necessary), use the data to: (1) Expedite 

the recall of distributed medical devices 

that are dangerous or defective and (2) 

facilitate the timely notification of 

patients or licensed practitioners of the 

risks associated with the medical 

device. 

In addition, the regulations include 

provisions for: (1) Exemptions and 

variances; (2) system and content 

requirements for tracking; (3) 

obligations of persons other than device 

manufacturers, e.g., distributors; records 

and inspection requirements; (4) 

confidentiality; and (5) record retention 

requirements. 

Respondents for this collection of 

information are medical device 

manufacturers, importers, and 

distributors of tracked implants or 

tracked l/s-l/s devices used outside a 

device user facility. Distributors include 

multiple and final distributors, 

including hospitals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

821.1(d) ................................................................................ 1 1 1 1 1 

821.2 and 821.30(e) ............................................................ 1 1 1 1 1 

821.25(a) .............................................................................. 12 1 12 76 912 

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Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices 69449 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

821.25(d) .............................................................................. 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 915 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

CFR section Number of 

recordkeepers 

Annual 

frequency of 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

821.25(b) .............................................................................. 12 46,260 555,120 1 555,120 

821.25(c)2 ............................................................................ 12 1 12 63 756 

821.25(c)(3) .......................................................................... 12 1,124 13,488 1 13,488 

Total .............................................................................. ........................ ........................ ........................ ........................ 569,364 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 One time burden. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1

21 CFR section Number of 

respondents 

Annual 

frequency of 

disclosure 

Total annual 

disclosures 

Hours per 

disclosure Total hours 

821.30(a) and (b) ................................................................. 17,000 1 17,000 1 17,000 

821.30(c) and (d) ................................................................. 17,000 1 17,000 1 17,000 

Total Hours ................................................................... ........................ ........................ ........................ ........................ 34,000 

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

The annual hourly burden for 

respondents involved with medical 

device tracking is estimated to be 

604,279 hours per year. The burden 

estimates cited in tables 1, 2, and 3 of 

this document are based on the number 

of device tracking orders issued in the 

last 3 years. 

This regulation also refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information found in 21 CFR 821.2(b), 

821.25(e), and 821.30(e) have been 

approved under OMB control number 

0910–0183. 

Dated: November 5, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28441 Filed 11–10–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0319] 

Draft Guidance for Industry and Food 

and Drug Administration Staff on Dear 

Health Care Provider Letters: 

Improving Communication of 

Important Safety Information; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and FDA staff entitled ‘‘Dear 

Health Care Provider Letters: Improving 

Communication of Important Safety 

Information.’’ Dear Health Care Provider 

(DHCP) Letters are correspondence— 

usually in the form of a mass mailing 

from the manufacturer or distributor of 

a human drug or biologic, or from 

FDA—intended to alert physicians and 

other health care providers to important 

new information about a marketed drug 

or biological product. This draft 

guidance provides recommendations on 

when to use a DHCP letter, the types of 

information to include in a DHCP letter, 

how to organize that information, and 

formatting techniques to make the 

information more accessible. The draft 

guidance is intended to improve the 

quality of DHCP letters to make them 

more effective communication tools for 

new information about marketed 

products. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by January 11, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

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