82 FR 6568 - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Draft Guidance for Industry and Review Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6568-6571 | |
| FR Document | 2017-01011 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Pages 6568-6571] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01011] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1307] Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers; Draft Guidance for Industry and Review Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' This draft guidance provides answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This draft guidance also provides answers to common questions about firms' communications regarding investigational drugs and devices (investigational products) to payors before FDA approval or clearance of such products. The Agency is issuing this draft guidance to explain FDA's current thinking on frequently asked questions regarding such communications in order to provide clarity for firms and payors. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-1307 for ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.66, Rm. 5431, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to this draft guidance document. FOR FURTHER INFORMATION CONTACT: Elaine Hu Cunningham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301- [[Page 6569]] 796-1200; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Paul Gadiock, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5448, Silver Spring, MD 20993-0002, 301-796-5736; or Kristin Davis, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-796-0418. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and review staff entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' This draft guidance provides answers to common questions regarding firms' communications of HCEI about their approved prescription drugs to payors. This draft guidance also addresses common questions relating to firms' dissemination of information about investigational products to payors before FDA approval or clearance of such products. For purposes of this draft guidance, the term ``payors'' collectively refers to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis that are responsible for making drug selection, formulary management, and/or coverage and reimbursement decisions on a population basis regarding drugs and/or devices for health care organizations, which may include entities such as integrated health care delivery networks, hospitals, and hospital systems. FDA is aware that payors seek a range of information on effectiveness, safety, and cost-effectiveness of approved drugs, including information from firms, to help support their drug selection, formulary management, and/or coverage and reimbursement decisions on a population basis. This information may differ from and may be in addition to the information FDA reviews in order to make drug approval decisions. Because coverage and reimbursement decisions by payors impact a large number of patients, FDA believes it is essential that HCEI provided by firms to payors about their approved drugs be truthful and non-misleading. With respect to HCEI regarding approved drugs, section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)), as amended by section 114 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and section 3037 of the 21st Century Cures Act (Pub. L. 114-255), includes a provision regarding communication of HCEI about such drugs to payors. Section 502(a) indicates that HCEI provided to payors carrying out their responsibilities for the selection of drugs for coverage or reimbursement shall not be considered to be false or misleading if the HCEI relates to an FDA-approved indication for the drug, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the FDA-approved labeling for the drug. Section III.A of this draft guidance provides FDA's current thinking on key concepts in section 502(a) and recommendations for how firms can communicate HCEI about approved drugs to payors in accordance with this section to help ensure that payors have information needed to make informed drug selection, formulary management, and/or coverage and reimbursement decisions and to help ensure that the information is not false or misleading. Section III.A also discusses how FDA's requirements for submission of promotional materials apply to HCEI about approved drugs disseminated by firms to payors. If a firm disseminates HCEI about an approved drug in accordance with this draft guidance, when finalized, FDA does not intend to consider such information false or misleading. In addition, FDA does not intend to use HCEI about approved drugs disseminated consistent with this draft guidance, when finalized, as providing evidence of a new intended use. FDA also recognizes that due in part to their need, in some situations, to plan for and make coverage and reimbursement decisions far in advance of the effective date of such decisions, payors are also interested in receiving information from drug and device firms about medical products that are not yet approved or cleared by FDA for any use (referred to in this draft guidance as investigational products). Section III.B discusses FDA's thinking with respect to communication by firms to payors of information about investigational products. As with HCEI about approved prescription drugs, it is essential that information provided by firms about their investigational products be truthful and non-misleading. Therefore, section III.B also lays out a series of recommendations to help achieve these goals. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling--Questions and Answers.'' The guidance provides information for medical product firms about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA- required labeling for the product but that may be consistent with the FDA-required labeling for the product. In addition, FDA is announcing in this issue of the Federal Register that it is reopening the comment period for the notice of public hearing that appeared in the Federal Register of September 1, 2016, concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. The comment period will be reopened for 90 days, until January 19, 2017. As announced in the notice of public hearing, FDA is engaged in a comprehensive review of its regulations and policies governing communications by firms about unapproved uses of approved or cleared medical products, and the comments it receives will inform FDA's policy development in this area. FDA will consider the feedback it receives in all three of these dockets as the Agency continues to review its policies on firm communications about medical products, and interested persons may wish to review the documents FDA has issued in all three dockets before submitting comments to any of the relevant dockets. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent the current thinking of FDA on certain commonly asked questions regarding firms' communications with payors. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it 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 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 [[Page 6570]] 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 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. Title: Drug Manufacturer Communications of Health Care Economic Information to Payors Under FD&C Act Section 502(a); Drug and Device Manufacturer Communications With Payors Regarding Investigational Products. Description of Respondents: For information that should be included when HCEI is disseminated to payors, respondents to this collection of information are firms that manufacture prescription human drug products, including biological products; for information that should be included with communications with payors about investigational products, respondents to this collection of information are firms that manufacture prescription human drug products, including biological products, and medical devices. Burden Estimate: This draft guidance includes recommendations regarding information that firms should include in HCEI for prescription drugs if they choose to disseminate such materials (``HCEI materials'') to payors, in accordance with section 502(a). Specifically, FDA recommends that various aspects of study design and methodology of an economic analysis (i.e., type of analysis, modeling technique, patient population, perspective/viewpoint, treatment comparator, time horizon, outcome measures, cost estimates, and assumptions); factors that limit generalizability of an economic analysis; limitations to an economic analysis; and sensitivity analyses, if applicable, be included in HCEI materials disseminated to payors to allow for informed decision-making and to help ensure that the HCEI is not false or misleading. Furthermore, FDA recommends that firms include other information when disseminating HCEI materials, as applicable, to provide a balanced and complete presentation. Such information includes a statement of the FDA-approved indication of the drug and a copy of the most current FDA- approved labeling. Under section 502(a), firms must also include a conspicuous and prominent statement to describe any material differences between the HCEI and the FDA-approved labeling. HCEI materials should also disclose whether certain studies or data sources were omitted from an economic analysis and how such selective inclusion of studies or data sources may alter the conclusions presented in the analysis. Moreover, FDA recommends that HCEI materials disclose important risk information associated with the approved use of the drug, and pursuant to section 502(a), must disclose any additional risk information related to assumptions that vary from the approved labeling. Finally, HCEI materials should disclose potential financial or affiliation biases to the extent reasonably known by firms at the time of dissemination. If firms choose to make communications to payors about investigational products, FDA recommends that firms include a clear statement with their communications that the product is under investigation and that the safety or effectiveness of the product has not been established. In addition, FDA recommends providing information related to the stage of product development (e.g., the phase of clinical trial in which a product is being studied and how it relates to the overall product development plan). Moreover, FDA recommends that firms provide followup information to payors if previously communicated information becomes outdated as a result of significant changes or as a result of new information regarding the product or its review status. Based on the post-marketing submissions of promotional materials using Form FDA 2253 received in calendar year (CY) 2015 for prescription drugs, FDA estimates that approximately 400 firms will disseminate 4,000 distinct HCEI materials annually. FDA estimates that it will take firms approximately 20 hours to compile and draft the information that this draft guidance recommends should be included if they choose to disseminate HCEI materials to payors. Based on the number of prescription drugs and devices approved/ cleared in CY 2015, FDA estimates that approximately 520 firms will prepare 1,040 distinct communications of information to payors about their investigational products annually. FDA estimates that it will take firms approximately 0.5 hours to compile and draft the information that this draft guidance recommends should be provided with communications to payors about investigational products. In addition, FDA estimates that approximately half of the firms will spend approximately 2 hours to compile and provide 520 distinct communications of followup information regarding previously communicated information to payors about their investigational products annually. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of information Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommended information to be included when 400 10 4,000 20........................................ 80,000 firms choose to disseminate HCEI materials to payors about prescription drugs under section 502(a). Recommended information to be included when 520 2 1,040 0.5 (30 minutes).......................... 520 firms choose to disseminate pre-approval communications about investigational drugs or devices to payors. [[Page 6571]] Follow up information to payors regarding 260 2 520 2......................................... 1,040 previously communicated information about investigational drugs and devices. ------------------------------------------------------------------------------------------------------- Total....................................... ............ ................ ............ .......................................... 81,560 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 314.81(b)(3)(i) (Form FDA 2253) have been approved under OMB control number 0910-0001. III. Other Issues for Consideration Although section 502(a) is specific to approved drugs and section III.A of this draft guidance addresses firms' communications of HCEI to payors only about approved drugs, FDA is interested in whether similar principles to those outlined in that section should apply to firms' communications of HCEI to payors about approved/cleared devices or whether different principles should be considered. FDA is specifically interested in identifying principles that, if applied to communications of HCEI about approved/cleared devices, could help ensure that such information is truthful and non-misleading and aids payors in making informed selection and/or coverage and reimbursement decisions about these products. FDA is interested in comments from interested parties on any of the topics addressed in this draft guidance and specifically requests comments from interested parties on the extent to which the principles provided in section III.A could be applicable to communications of HCEI about approved/cleared devices. To the extent that interested parties believe that different considerations should apply to medical devices or that guidance is needed on additional issues with respect to medical device firms' communications of HCEI about approved/cleared medical devices to payors, FDA is interested in input on those topics as well. FDA is also seeking comments from interested parties regarding communications of HCEI about animal drugs. Although FDA recognizes that the audience for HCEI about animal drugs may be different from that identified in section III.A as a result of differences in how payment decisions are made for animal drugs, FDA is interested in learning the extent to which the principles provided in section III.A could be applicable to communications of HCEI about animal drugs with appropriate audiences for such information. To the extent that commenters believe that different considerations should apply to animal drugs or that guidance is needed on additional issues with respect to animal drug firms' communications of HCEI about approved new animal drugs to appropriate audiences, FDA is interested in input on those topics as well. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov. Dated: January 6, 2017. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-01011 Filed 1-18-17; 8:45 am] BILLING CODE 4164-01-P
![6568 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
Dated: January 13, 2017. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Leslie Kux, https://www.regulations.gov. Follow the Agency will review this copy, including
Associate Commissioner for Policy. instructions for submitting comments. the claimed confidential information, in
[FR Doc. 2017–01187 Filed 1–18–17; 8:45 am] Comments submitted electronically, its consideration of comments. The
BILLING CODE 4164–01–P including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND comment will be made public, you are for public viewing and posted on
HUMAN SERVICES solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Division of Dockets
Food and Drug Administration confidential information that you or a Management. If you do not wish your
[Docket No. FDA–2016–D–1307] third party may not wish to be posted, name and contact information to be
such as medical information, your or made publicly available, you can
Drug and Device Manufacturer anyone else’s Social Security number, or provide this information on the cover
Communications With Payors, confidential business information, such sheet and not in the body of your
Formulary Committees, and Similar as a manufacturing process. Please note comments and you must identify this
Entities—Questions and Answers; that if you include your name, contact information as ‘‘confidential.’’ Any
Draft Guidance for Industry and information, or other information that information marked as ‘‘confidential’’
Review Staff; Availability identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. applicable disclosure law. For more
HHS. • If you want to submit a comment information about FDA’s posting of
ACTION: Notice of availability. with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
SUMMARY: The Food and Drug
public, submit the comment as a the information at: http://www.fda.gov/
Administration (FDA or Agency) is
written/paper submission and in the regulatoryinformation/dockets/
announcing the availability of a draft
manner detailed (see ‘‘Written/Paper default.htm.
guidance for industry and review staff
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
entitled ‘‘Drug and Device Manufacturer
Communications With Payors, Written/Paper Submissions read background documents or the
Formulary Committees, and Similar electronic and written/paper comments
Submit written/paper submissions as
Entities—Questions and Answers.’’ This received, go to https://
follows:
draft guidance provides answers to • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
common questions regarding the written/paper submissions): Division of docket number, found in brackets in the
communication of health care economic Dockets Management (HFA–305), Food heading of this document, into the
information (HCEI) about approved and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
prescription drugs by medical product Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
manufacturers, packers, distributers, • For written/paper comments Management, 5630 Fishers Lane, Rm.
and their representatives (firms) to submitted to the Division of Dockets 1061, Rockville, MD 20852.
payors, formulary committees, or other Management, FDA will post your Submit written requests for single
similar entities with knowledge and comment, as well as any attachments, copies of this draft guidance to the
expertise in the area of health care except for information submitted, Division of Drug Information, Center for
economic analysis (collectively referred marked and identified, as confidential, Drug Evaluation and Research, Food
to as payors). This draft guidance also if submitted as detailed in and Drug Administration, 10001 New
provides answers to common questions ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
about firms’ communications regarding Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
investigational drugs and devices must include the Docket No. FDA– 0002; the Office of Communication,
(investigational products) to payors 2016–D–1307 for ‘‘Drug and Device Outreach and Development, Center for
before FDA approval or clearance of Manufacturer Communications With Biologics Evaluation and Research,
such products. The Agency is issuing Payors, Formulary Committees, and Food and Drug Administration, 10903
this draft guidance to explain FDA’s Similar Entities—Questions and New Hampshire Ave., Bldg. 71, Rm.
current thinking on frequently asked Answers.’’ Received comments will be 3128, Silver Spring, MD 20993–0002;
questions regarding such placed in the docket and, except for the Office of the Center Director,
communications in order to provide those submitted as ‘‘Confidential Guidance and Policy Development,
clarity for firms and payors. Submissions,’’ publicly viewable at Center for Devices and Radiological
DATES: Although you can comment on https://www.regulations.gov or at the Health, Food and Drug Administration,
any guidance at any time (see 21 CFR Division of Dockets Management 10903 New Hampshire Ave., Bldg.66,
10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday Rm. 5431, Silver Spring, MD 20993–
considers your comment on this draft through Friday. 0002. Send one self-addressed adhesive
guidance before it begins work on the • Confidential Submissions—To label to assist that office in processing
final version of the guidance, submit submit a comment with confidential your requests. See the SUPPLEMENTARY
either electronic or written comments information that you do not wish to be INFORMATION section for electronic
mstockstill on DSK3G9T082PROD with NOTICES
on the draft guidance by April 19, 2017. made publicly available, submit your access to this draft guidance document.
ADDRESSES: You may submit comments comments only as a written/paper FOR FURTHER INFORMATION CONTACT:
as follows: submission. You should submit two Elaine Hu Cunningham, Center for Drug
copies total. One copy will include the Evaluation and Research, Food and
Electronic Submissions information you claim to be confidential Drug Administration, 10903 New
Submit electronic comments in the with a heading or cover note that states Hampshire Ave., Bldg. 51, Rm. 3203,
following way: ‘‘THIS DOCUMENT CONTAINS Silver Spring, MD 20993–0002, 301–
VerDate Sep<11>2014 21:20 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/82_FR_6580/page/1.svg)
![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6571
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Type of information responses per Total hours
respondents responses per response
respondent
Follow up information to payors regarding previously 260 2 520 2 ............................ 1,040
communicated information about investigational
drugs and devices.
Total ........................................................................ ...................... ............................ ...................... ............................... 81,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance also refers to which the principles provided in update to a March 2004 document
previously approved collections of section III.A could be applicable to entitled ‘‘What You Need to Know
information found in FDA regulations. communications of HCEI about animal About Mercury in Fish and Shellfish.’’
The collections of information in 21 drugs with appropriate audiences for FDA and EPA are now announcing
CFR 314.81(b)(3)(i) (Form FDA 2253) such information. To the extent that revised fish advice that contains advice
have been approved under OMB control commenters believe that different and supplemental questions and
number 0910–0001. considerations should apply to animal answers for those who want to
drugs or that guidance is needed on understand the advice in greater detail.
III. Other Issues for Consideration additional issues with respect to animal FOR FURTHER INFORMATION CONTACT:
Although section 502(a) is specific to drug firms’ communications of HCEI FDA: William R. Jones, Center for Food
approved drugs and section III.A of this about approved new animal drugs to Safety and Applied Nutrition, Food and
draft guidance addresses firms’ appropriate audiences, FDA is Drug Administration, 5001 Campus Dr.,
communications of HCEI to payors only interested in input on those topics as College Park, MD 20740–3835, 240–
about approved drugs, FDA is interested well. 402–1422, William.Jones@fda.hhs.gov;
in whether similar principles to those IV. Electronic Access EPA: Lisa Larimer, U.S. Environmental
outlined in that section should apply to Protection Agency, 1200 Pennsylvania
firms’ communications of HCEI to Persons with access to the Internet Ave. NW., MS 4305T, Washington, DC
payors about approved/cleared devices may obtain the draft guidance at http:// 20460, 202–566–1017, Larimer.Lisa@
or whether different principles should www.fda.gov/Drugs/Guidance epa.gov.
be considered. FDA is specifically ComplianceRegulatoryInformation/
Guidances/default.htm, http:// SUPPLEMENTARY INFORMATION:
interested in identifying principles that,
if applied to communications of HCEI www.fda.gov/BiologicsBloodVaccines/ I. Background
about approved/cleared devices, could GuidanceCompliance
In the Federal Register of June 11,
help ensure that such information is RegulatoryInformation/Guidances/
2014 (79 FR 33559), FDA, in
truthful and non-misleading and aids default.htm, http://www.fda.gov/
coordination with EPA, announced the
payors in making informed selection MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/ availability of the draft updated fish
and/or coverage and reimbursement advice, entitled ‘‘Fish: What Pregnant
default.htm, or https://
decisions about these products. FDA is Women and Parents Should Know’’ (the
www.regulations.gov.
interested in comments from interested notice), and made the draft updated
parties on any of the topics addressed in Dated: January 6, 2017. advice available for public comment.
this draft guidance and specifically Jeremy Sharp, The draft fish advice was intended to
requests comments from interested Deputy Commissioner for Policy, Planning, update advice previously published by
parties on the extent to which the Legislation, and Analysis. EPA and FDA in March 2004 (Ref. 1), to
principles provided in section III.A [FR Doc. 2017–01011 Filed 1–18–17; 8:45 am] make it consistent with the 2010 Dietary
could be applicable to communications BILLING CODE 4164–01–P Guidelines for Americans and to modify
of HCEI about approved/cleared the wording and organization of the
devices. To the extent that interested 2004 advice to enhance the likelihood
parties believe that different DEPARTMENT OF HEALTH AND that it would be followed by the target
considerations should apply to medical HUMAN SERVICES audience. The 2004 advice on fish
devices or that guidance is needed on consumption itself was preceded by
additional issues with respect to Food and Drug Administration
earlier recommendations published by
medical device firms’ communications [Docket No. FDA–2014–N–0595] FDA in September 1994 and revised in
of HCEI about approved/cleared medical May 1995 (http://www.fda.gov/ohrms/
devices to payors, FDA is interested in Advice About Eating Fish, From the dockets/ac/02/briefing/3872_
input on those topics as well. Environmental Protection Agency and advisory%207.pdf), followed by
FDA is also seeking comments from Food and Drug Administration; separate, but simultaneously issued,
interested parties regarding Revised Fish Advice; Availability FDA and EPA fish consumption advice
communications of HCEI about animal in 2001. FDA’s 2001 advice addressed
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration,
drugs. Although FDA recognizes that HHS. commercial fish; EPA’s 2001 advice
the audience for HCEI about animal ACTION: Notice of availability. addressed locally caught fish. The 2014
drugs may be different from that notice announcing the availability of the
identified in section III.A as a result of SUMMARY: In June 2014, the Food and draft updated fish advice stated that the
differences in how payment decisions Drug Administration (FDA) and the U.S. comment period would be open until 30
are made for animal drugs, FDA is Environmental Protection Agency (EPA) days after the last transcript became
interested in learning the extent to (the Agencies) jointly released a draft available from either the FDA Risk
VerDate Sep<11>2014 21:20 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/82_FR_6580/page/4.svg)
Document Created: 2018-02-01 15:16:37
Document Modified: 2018-02-01 15:16:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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 April 19, 2017. | |
| Contact | Elaine Hu Cunningham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301- 796-1200; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Paul Gadiock, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5448, Silver Spring, MD 20993-0002, 301-796-5736; or Kristin Davis, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-796-0418. | |
| FR Citation | 82 FR 6568 |
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