Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information; Availability, 3827-3828 [2014-01305]

Download as PDF Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Scott McNamee, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993–0002, 301–796–5523; or Charles Durfor, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G424, Silver Spring, MD 20993–0002, 301–796–6970. SUPPLEMENTARY INFORMATION: I. Background This draft guidance entitled ‘‘Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices)’’ is intended to update the 1998 guidance of the same name regarding the use of animalderived material in medical device manufacturing. The 1998 guidance addressed ways to reduce the potential for exposure to bovine spongiform encephalopathy. The draft guidance continues to focus on the control of transmissible disease, and contains recommendations for documenting the source of animal tissue, conducting viral inactivation validation studies, as well as recommendations about the role of careful animal husbandry in ensuring safe tissue sources. The information in this guidance is applicable to all medical devices that contain or are exposed to animalderived materials (e.g., bovine, ovine, porcine, avian materials) with the exception of in vitro diagnostic devices. The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions. Consideration of these issues should aid in reducing the risk of infectious disease transmission by medical devices. This draft guidance, when finalized, will supersede the guidance entitled ‘‘Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)’’, announced in the Federal Register of November 6, 1998 (63 FR 60009). sroberts on DSK5SPTVN1PROD with NOTICES II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on medical devices containing materials derived from animal sources (except for in vitro diagnostic devices). It does not create or confer any rights for or on any person and does not operate to bind VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. Dated: January 14, 2014. Leslie Kux, Assistant Commissioner for Policy. III. Electronic Access 3827 BILLING CODE 4160–01–P Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 2206 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft 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 21 CFR part 807 subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 814 subpart H have been approved under OMB control number 0910–0332; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 [FR Doc. 2014–01232 Filed 1–22–14; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0319] 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. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ‘‘Dear Health Care Provider Letters: Improving Communication of Important Safety Information.’’ This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible. This guidance finalizes the draft guidance issued in November 2010. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that SUMMARY: E:\FR\FM\23JAN1.SGM 23JAN1 3828 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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: Lori A. Bickel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993, 301–796–0210; 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: sroberts on DSK5SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance for industry and FDA staff entitled ‘‘Dear Health Care Provider Letters: Improving Communication of Important Safety Information.’’ This document offers specific guidance to industry and FDA staff on the content and format of DHCP letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance gives specific instruction on what should and should not be included in DHCP letters. To date, some DHCP letters have been too long, have contained promotional material, or otherwise have not met the goals set forth in the applicable regulation (21 CFR 200.5). In some cases, health care providers have not been aware of important new information, and have been unable to communicate it to patients, because the letters’ content and length have made it difficult to find the relevant information. In addition, letters have sometimes been sent for the wrong reasons. In addition to content and format recommendations for each type of DHCP letter, the guidance also includes advice on consulting with FDA to develop a DHCP letter, when to send a letter, what type of letter to send, and conducting an assessment of the letter’s impact. In the Federal Register of November 12, 2010 (75 FR 69449), FDA announced the availability of a draft guidance for industry and FDA staff entitled ‘‘Dear Health Care Provider Letters: Improving VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 Communication of Important Safety Information.’’ The notice gave interested persons an opportunity to comment by January 11, 2011. The Agency received several comments from health care providers, firms, and other groups. We have carefully considered the comments and, where appropriate, have made corrections, added information, or clarified information in the guidance in response to the comments or on our own initiative. This guidance finalizes the draft guidance issued in November 2010. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on ‘‘Dear Health Care Provider Letters: Improving Communication of Important Safety Information.’’ 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 This guidance contains information collection provisions that 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 were approved under OMB control number 0910–0754. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Dated: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01305 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0032] Improving the Quality of Abbreviated New Drug Application Submissions to the Food and Drug Administration; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for comments. ACTION: The Food and Drug Administration (FDA) is establishing a public docket to receive input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements to FDA’s Office of Generic Drugs (OGD). Specifically, FDA is interested in hearing about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help address, for example by providing more or better information to industry. This action is intended to solicit suggestions that will improve the completeness and quality of ANDA submissions to FDA. FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry. More complete, higher quality ANDA submissions will positively affect the availability of low-cost, highquality generic drugs to the public. DATES: Although FDA welcomes comments at any time, to help FDA address issues related to ANDA submission quality in a timely fashion, we encourage submission of electronic or written comments by March 24, 2014. ADDRESSES: Submit electronic comments to https:// 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. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7519 SUMMARY: E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3827-3828]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01305]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]


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 guidance for industry and FDA staff entitled ``Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information.'' This guidance offers specific recommendations to 
industry on the content and format of Dear Health Care Provider (DHCP) 
letters. These letters are sent by manufacturers or distributors to 
health care providers to communicate an important drug warning, a 
change in prescribing information, or a correction of misinformation in 
prescription drug promotional labeling or advertising. This guidance 
provides recommendations on when to use a DHCP letter, the types of 
information to include in the DHCP letter, how to organize the 
information so that it is communicated effectively to health care 
providers, and formatting techniques to make the information more 
accessible. This guidance finalizes the draft guidance issued in 
November 2010.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that

[[Page 3828]]

office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to https://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: Lori A. Bickel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993, 301-796-
0210; 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 guidance for industry and 
FDA staff entitled ``Dear Health Care Provider Letters: Improving 
Communication of Important Safety Information.'' This document offers 
specific guidance to industry and FDA staff on the content and format 
of DHCP letters. These letters are sent by manufacturers or 
distributors to health care providers to communicate an important drug 
warning, a change in prescribing information, or a correction of 
misinformation in prescription drug promotional labeling or 
advertising. This guidance gives specific instruction on what should 
and should not be included in DHCP letters. To date, some DHCP letters 
have been too long, have contained promotional material, or otherwise 
have not met the goals set forth in the applicable regulation (21 CFR 
200.5). In some cases, health care providers have not been aware of 
important new information, and have been unable to communicate it to 
patients, because the letters' content and length have made it 
difficult to find the relevant information. In addition, letters have 
sometimes been sent for the wrong reasons.
    In addition to content and format recommendations for each type of 
DHCP letter, the guidance also includes advice on consulting with FDA 
to develop a DHCP letter, when to send a letter, what type of letter to 
send, and conducting an assessment of the letter's impact.
    In the Federal Register of November 12, 2010 (75 FR 69449), FDA 
announced the availability of a draft guidance for industry and FDA 
staff entitled ``Dear Health Care Provider Letters: Improving 
Communication of Important Safety Information.'' The notice gave 
interested persons an opportunity to comment by January 11, 2011. The 
Agency received several comments from health care providers, firms, and 
other groups. We have carefully considered the comments and, where 
appropriate, have made corrections, added information, or clarified 
information in the guidance in response to the comments or on our own 
initiative. This guidance finalizes the draft guidance issued in 
November 2010.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on ``Dear Health Care Provider Letters: 
Improving Communication of Important Safety Information.'' 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

    This guidance contains information collection provisions that 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 were approved under OMB 
control number 0910-0754.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01305 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P
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