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 

mstockstill on DSKH9S0YB1PROD with NOTICES

69450 Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices 

1Mazor K, S. Andrade, J. Auger, et al., 

‘‘Communicating Safety Information to Physicians: 

An Examination of Dear Doctor Letters,’’ 

Pharmacoepidemiol Drug Safety, 14:869–875, 2005. 

self-addressed adhesive label to assist 

those offices in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft 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: 

Sandy Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4206, 

Silver Spring, MD 20993–0002, 

301–796–2270; or Stephen Ripley, 

Center for Biologics Evaluation and 

Research (HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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.’’ 

Important new information about 

prescription drug and biological 

products emerges throughout a 

product’s lifecycle. For marketed 

products, there may be occasions when 

it is important to communicate new 

information promptly to health care 

practitioners involved in prescribing or 

dispensing a drug, or in caring for 

patients who receive a drug. The DHCP 

letter is an important mechanism (one of 

a number of different mechanisms) used 

to communicate important new 

information to health care professionals 

about a marketed product. 

Formal and informal evaluations of 

DHCP letters have shown that the 

communication quality of DHCP 

letters—the extent to which the 

information is accessible and can be 

understood—varies widely. A study 

reported in 2005 evaluated the quality 

of a group of DHCP letters sent during 

2000 and 2001 that were intended to 

communicate important new drug safety 

information.1 The study found that 

there is a correlation between the 

quality or perceived quality of a DHCP 

letter and the extent to which 

physicians perceive the new 

information as important. Letters that 

were evaluated as clearer, more concise, 

better organized and formatted, and 

focused on the most important aspects 

of the new safety information were 

considered to be more effective in 

communicating the new information. 

FDA believes guidance concerning the 

format and content of the DHCP letter 

would be beneficial in improving the 

effectiveness of DHCP letters in 

communicating drug information. 

Accordingly, this draft guidance 

contains recommendations on when to 

use a DHCP letter, what types of 

information to include in a DHCP letter, 

how to organize that information, and 

formatting techniques to make the 

information in the letter more 

accessible. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the format and content of DHCP 

letters. 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. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 that 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 for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comments on the 

following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

FDA estimates the burden of this 

collection of information as follows: 

Based on a review of MedWatch 

Safety Alerts for 2008 and 2009, we 

identified each Dear Health Care 

Provider Letter sent and the identity of 

each sponsor sending out a Dear Health 

Care Provider Letter for each year. We 

estimate that we will receive 

approximately 30 Dear Health Care 

Provider letters annually from 

approximately 25 application holders. 

FDA professionals familiar with Dear 

Health Care Provider Letters and with 

the recommendations in the draft 

guidance estimate that it should take an 

application holder approximately 100 

hours to prepare and send Dear Health 

Care Provider Letters in accordance 

with the draft guidance. Therefore we 

estimate the annual reporting burden as 

follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Hours per 

response Total hours 

Annual Average ................................................................... 25 1.20 30 100 3,000 

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

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices 69451 

In the draft guidance, we refer to an 

earlier guidance for industry entitled 

‘‘Using Electronic Means to Distribute 

Certain Product Information’’ (71 FR 

26102, May 3, 2006). That guidance 

referred to previously approved 

collections of information found in FDA 

regulations that are subject to review by 

OMB. The collections of information in 

that guidance have been approved 

under OMB control number 0910–0249. 

III. 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. It is no longer necessary to 

send two copies of mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda.

gov/BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: November 5, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28440 Filed 11–10–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Microbicide Innovation 

Program (MIP VI) (R21/R33). 

Date: December 2–3, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites—Chevy Chase 

Pavilion, 4300 Military Rd. NW., Tenleytown 

Ballroom, Washington, DC 20015. 

Contact Person: Roberta Binder, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIAID/NIH/DHHS, 6700B Rockledge Drive, 

Room 3130, Bethesda, MD 20892–7616, (301) 

496–7966, rbinder@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Support for Conference and 

Scientific Meetings. 

Date: December 6–8, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: B. Duane Price, PhD, 

Scientific Review Officer, Scientific Review 

Program, DHHS/NIH/NIAID/DEA, Room 

3139, 6700B Rockledge Drive, MSC 7616, 

Bethesda, MD 20892, 301–451–2592, 

pricebd@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Unsolicited R24. 

Date: December 6, 2010. 

Time: 10 a.m. to 11:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Eleazar Cohen, PhD, 

Scientific Review Officer, Division of 

Extramural Activites, NIAID/NIH/DHHS, 

6700B Rockledge Drive, Room 3129, 

Bethesda, MD 20892, 301–435–3564, 

ec17w@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: November 4, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28457 Filed 11–10–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, National 

Institute of Dental and Craniofacial 

Research. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

National Institute of Dental & 

Craniofacial Research, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, National Institute of Dental and 

Craniofacial Research. 

Date: December 12–13, 2010. 

Time: December 12, 2010, 7 p.m. to 9 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: Doubletree Hotel Bethesda 

(Formerly Holiday Inn Select), 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Time: December 13, 2010, 8 a.m. to 5 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 30, 30 Center Drive, 117, Bethesda, 

MD 20892. 

Contact Person: Alicia J. Dombroski, PhD, 

Director, Division of Extramural Activities, 

Natl Inst of Dental and Craniofacial Research, 

National Institutes of Health, Bethesda, MD 

20892. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcr.nih.gov/about/Council 

Committees.asp, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: November 4, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28460 Filed 11–10–10; 8:45 am] 

BILLING CODE 4140–01–P 

mstockstill on DSKH9S0YB1PROD with NOTICES