83 FR 27602 - Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 114 (June 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 114 (June 13, 2018)
| Page Range | 27602-27605 | |
| FR Document | 2018-12631 |
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)] [Notices] [Pages 27602-27605] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12631] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2285] Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling--Questions and Answers; Guidance for Industry; 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 guidance for industry entitled ``Medical Product Communications That Are Consistent With the FDA-Required Labeling-- Questions and Answers.'' This guidance provides information for manufacturers, packers, and distributors and their representatives (collectively ``firms'') of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively ``medical products''), about how FDA evaluates their medical product communications that present information that is not contained in the FDA-required labeling for the product but that may be [[Page 27603]] consistent with the FDA-required labeling for the product. The Agency is issuing this guidance to explain FDA's current thinking on commonly asked questions regarding such communications to provide clarity for firms. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: The announcement of the guidance is published in the Federal Register on June 13, 2018. Submit written comments on the collection of information by July 13, 2018. ADDRESSES: To ensure comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910--NEW and title ``Recommended Content of Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers; Guidance for Industry.'' Also include the FDA docket number found in brackets in the heading of this document. You may submit either electronic or written comments on Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2285 for ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers; Guidance for Industry; Availability.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; 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; Division of Small Manufacturers, International and Consumer Assistance, Office of Communication, Education and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; or to Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Kristin Davis, Office of Policy, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-796-0418; or Elizabeth Pepinsky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3248, Silver Spring, MD 20993-0002, 301- 796-1200; or 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; or Ana Loloei Marsal, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-796-8774; or Thomas Moskal, Center for Veterinary Medicine, Food and Drug Administration, 7519 [[Page 27604]] Standish Pl. (HFV-216), Rockville, MD 20855, 240-402-6251. Regarding the information collection: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers.'' This guidance provides information for firms about how FDA evaluates their medical product communications (that fall within the scope of FDA's regulatory authority) that present information that is not contained in the FDA- required labeling \1\ for the product but that may be consistent with the FDA-required labeling for the product. --------------------------------------------------------------------------- \1\ As used in the guidance, the term FDA-required labeling includes the labeling reviewed and approved by FDA as part of the medical product marketing application review process. For products not subject to premarket approval, but instead subject to premarket notification (510(k)) requirements or exempt from premarket review, the term FDA-required labeling includes the labeling that provides adequate directions for use and other information required to appear on the label or in labeling. --------------------------------------------------------------------------- FDA determines whether a medical product is safe and effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling submitted with the product's marketing application or submission (and for devices, also during the classification process). In making this determination, FDA evaluates whether the conditions of use in the proposed labeling are supported by the required levels and types of evidence of safety and effectiveness and whether the benefits of using the product under those specific conditions of use outweigh the risks of the product. After FDA approves, clears, or licenses a medical product, the FDA-required labeling sets forth the conditions of use under which the product has been shown to meet the relevant standard for marketing, and it provides directions and information on how to use the product safely and effectively under those conditions. Medical product firms have told FDA that they are interested in communicating, including in their promotional materials, data and information about the approved/cleared/licensed uses of their products that are not contained in their products' FDA-required labeling. We are aware that firms have questions about how FDA determines whether such communications are consistent with the FDA-required labeling. The guidance describes FDA's thinking when examining the consistency of a firm's product communications with that product's own FDA-required labeling. As explained in the guidance, if a firm communicates information that is not contained in its product's FDA- required labeling but that is determined to be consistent with the FDA- required labeling, FDA does not intend to rely on that communication to establish a new intended use, different from the use(s) for which the product is legally marketed. Establishing a product's intended uses is an element in establishing certain violations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act. However, firms' communications about their products that are consistent with the products' FDA-required labeling but that are false or misleading may subject a firm to enforcement action under the FD&C Act. Thus, the guidance not only describes FDA's thinking on communications that are consistent with the FDA-required labeling, but also provides general recommendations intended to aid firms in complying with requirements in the FD&C Act and FDA's implementing regulations for conveying information that is consistent with the FDA-required labeling in a truthful and non-misleading way. The general recommendations provided in the guidance for conveying information in a truthful and non-misleading way are applicable only to drug and device labeling and prescription drug and restricted device advertising that are consistent with the FDA-required labeling. Communication of information that is not consistent with the FDA-required labeling is outside the scope of these recommendations. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on firms' communications for their medical products that may be consistent with the FDA-required labeling. 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection for OMB review and clearance. Title: Recommended Content of Medical Product Communications That Are Consistent With the FDA-Required Labeling; OMB Control No. 0910-- NEW. The guidance includes third-party disclosure recommendations regarding information that firms should include in communications that contain information not found in the FDA-required labeling for their medical products but that are consistent with the FDA-required labeling (as explained in the guidance) if they choose to publicly disseminate such materials. The guidance recommends that various aspects of study design and methodology for studies relied on in such communications be disclosed to provide material contextual information (e.g., type of study, study objectives, product dosage/use regimens, control(s) used, patient population studied), and that material limitations related to the study design, methodology, and results also be disclosed in a clear and prominent manner to help ensure that the communications are not false or misleading. Additionally, the guidance recommends that firms accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings. Finally, the guidance recommends that firms disclose material contextual information from the FDA-required labeling in these communications, such as data and information from studies in the FDA- required labeling that are relevant to the data or information presented in the communication (e.g., if a communication provides post- market information about the types and rates of occurrence of adverse events that have been observed in practice, the communication should also include information from the FDA-required labeling about the types and rates of occurrence of adverse reactions observed in clinical trials to provide context). In the Federal Register of January 19, 2017 (82 FR 6575), we published a notice announcing the availability of the draft guidance document and included an analysis under the PRA of the information collection burden associated with our recommendations. No comments were received in response to the four information collection topics solicited in the notice. According to FDA data, approximately 162,000 FDA-regulated [[Page 27605]] promotional materials are prepared by approximately 500 firms annually. Of these materials, we estimate approximately 5 percent contain unique presentations of information consistent with FDA-required labeling, as described in the guidance, submitted by approximately 64 percent (or 324) of the firms. Anticipating that the number of these FDA-regulated promotional materials will soon increase to 6 percent, we estimate the 324 firms will prepare and disseminate annually 9,720 FDA-regulated promotional materials that contain unique presentations of information that is consistent with the FDA-required labeling, as described in the guidance, and that therefore are recommended to include the proposed third party disclosures. Based on our experience reviewing FDA- regulated promotional materials for medical products, we estimate it will take respondents approximately 4 hours per unique presentation to prepare and incorporate the disclosures recommended in the guidance, if they choose to disseminate this information. We therefore estimate the burden of the information collection as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of information Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommended information to be included when firms choose to 324 30 9,720 4 38,880 disseminate communications that are consistent with the FDA- required labeling................................................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA is issuing this final guidance subject to OMB approval of the collection of information. Before implementing the information collection provisions of the guidance, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the collection of information, including OMB control number(s) for newly approved collections. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov. Dated: June 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12631 Filed 6-12-18; 8:45 am] BILLING CODE 4164-01-P
![27602 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
New York City, Washington DC, 5 U.S. condition. Private personally department uses to process and send
territories (American Samoa, the identifiable information (PII) is case notification data from their
Commonwealth of Northern Mariana collected from automated electronic jurisdiction to CDC. Specifically, the
Islands, Guam, Puerto Rico, and the U.S. messages and information can be burden estimates include separate
Virgin Islands), and 3 freely associated retrieved by PII. In addition, some burden hours incurred for automated
states (Federated States of Micronesia, combinations of submitted data and non-automated transmissions,
the Republic of the Marshall Islands, elements could potentially be used to separate weekly burden hours incurred
and the Republic of Palau). This identify individuals. Private information for modernizing surveillance systems as
information is shared across is not be disclosed unless otherwise part of NNDSS Modernization Initiative
jurisdictional boundaries and both compelled by law. All data are treated
(NMI) implementation, separate burden
surveillance and prevention and control in a secure manner consistent with the
hours incurred for annual data
activities are coordinated at regional technical, administrative, and
and national levels. operational controls required by the reconciliation and submission, and
Approximately 90% of case Federal Information Security separate one-time burden hours
notifications are encrypted and Management Act of 2002 (FISMA) and incurred for the addition of new
submitted to NNDSS electronically from the 2010 National Institute of Standards diseases and data elements. The burden
already existing databases by automated and Technology (NIST) Recommended estimates also include the one-time
electronic messages. When automated Security Controls for Federal burden for reporting jurisdictions for the
transmission is not possible, case Information Systems and Organizations. addition of case notification data for
notifications are faxed, emailed, Weekly tables of nationally notifiable CP–CRE and C. auris and disease-
uploaded to a secure network or entered diseases are available through CDC specific data elements for CP–CRE. The
into a secure website. All case WONDER and data.cdc.gov. Annual estimated annual burden for the 233
notifications that are faxed, emailed, summaries of finalized nationally respondents is 18,619 hours. The cost of
and uploaded are done so in the form notifiable disease data are published on the information collection is $787,846.
of an aggregate weekly or annual report, CDC WONDER and data.cdc.gov and The total burden hours increased from
not individual cases. These different disease-specific data are published by 18,529 to 18,619 since the last revision
mechanisms used to send case individual CDC programs. because of the addition of diseases and
notifications to CDC vary by the The burden estimates include the disease-specific data elements.
jurisdiction and the disease or number of hours that the public health
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden per
Type of respondents Form name responses per burden
respondents response
respondent (in hours)
(in hours)
States ................................................ Weekly (Automated) ......................... 50 52 20/60 867
States ................................................ Weekly (Non-Automated) ................. 10 52 2 1,040
States ................................................ Weekly (NMI Implementation) .......... 50 52 4 10,400
States ................................................ Annual .............................................. 50 1 75 3,750
States ................................................ One-time Addition of Diseases and 50 1 10 485
Data Elements.
Territories .......................................... Weekly (Automated) ......................... 1 52 20/60 17
Territories .......................................... Weekly, Quarterly (Non-Automated) 5 56 20/60 93
Territories .......................................... Weekly (NMI Implementation) .......... 5 52 4 1,040
Territories .......................................... Annual .............................................. 5 1 5 25
Territories .......................................... One-time Addition of Diseases and 1 1 10/60 1
Data Elements.
Freely Associated States .................. Weekly, Quarterly (Non-Automated) 3 56 20/60 56
Freely Associated States .................. Annual .............................................. 3 1 5 15
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND announcing the availability of a
Acting Chief, Information Collection Review HUMAN SERVICES guidance for industry entitled ‘‘Medical
Office, Office of Scientific Integrity, Office Product Communications That Are
of the Associate Director for Science, Office Food and Drug Administration Consistent With the FDA-Required
of the Director, Centers for Disease Control Labeling—Questions and Answers.’’
[Docket No. FDA–2016–D–2285]
and Prevention. This guidance provides information for
[FR Doc. 2018–12637 Filed 6–12–18; 8:45 am] Medical Product Communications That manufacturers, packers, and distributors
BILLING CODE 4163–18–P Are Consistent With the Food and and their representatives (collectively
Drug Administration-Required ‘‘firms’’) of drugs and medical devices
Labeling—Questions and Answers; for humans, including those that are
amozie on DSK3GDR082PROD with NOTICES1
Guidance for Industry; Availability licensed as biological products, and
AGENCY: Food and Drug Administration, animal drugs (collectively ‘‘medical
HHS. products’’), about how FDA evaluates
their medical product communications
ACTION: Notice of availability.
that present information that is not
SUMMARY: The Food and Drug contained in the FDA-required labeling
Administration (FDA or Agency) is for the product but that may be
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![Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27605
promotional materials are prepared by materials will soon increase to 6 experience reviewing FDA-regulated
approximately 500 firms annually. Of percent, we estimate the 324 firms will promotional materials for medical
these materials, we estimate prepare and disseminate annually 9,720 products, we estimate it will take
approximately 5 percent contain unique FDA-regulated promotional materials respondents approximately 4 hours per
presentations of information consistent that contain unique presentations of unique presentation to prepare and
with FDA-required labeling, as information that is consistent with the incorporate the disclosures
described in the guidance, submitted by FDA-required labeling, as described in recommended in the guidance, if they
approximately 64 percent (or 324) of the the guidance, and that therefore are choose to disseminate this information.
firms. Anticipating that the number of recommended to include the proposed We therefore estimate the burden of
these FDA-regulated promotional third party disclosures. Based on our the information collection as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual Total
Type of information burden per
respondents per disclosures hours
disclosure
respondent
Recommended information to be included when firms
choose to disseminate communications that are con-
sistent with the FDA-required labeling ............................. 324 30 9,720 4 38,880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA is issuing this final guidance DEPARTMENT OF HEALTH AND thinking on frequently asked questions
subject to OMB approval of the HUMAN SERVICES regarding these topics in order to
collection of information. Before provide clarity for firms and payors.
implementing the information Food and Drug Administration FDA is also announcing that a proposed
collection provisions of the guidance, [Docket No. FDA–2016–D–1307] collection of information has been
FDA will publish a notice in the Federal submitted to the Office of Management
Register announcing OMB’s decision to Drug and Device Manufacturer and Budget (OMB) for review and
approve, modify, or disapprove the Communications With Payors, clearance under the Paperwork
collection of information, including Formulary Committees, and Similar Reduction Act of 1995.
OMB control number(s) for newly Entities—Questions and Answers; DATES: The announcement of the
approved collections. Guidance for Industry; Availability guidance is published in the Federal
AGENCY: Food and Drug Administration, Register on June 13, 2018. Submit
III. Electronic Access written comments on the collection of
HHS.
information by July 13, 2018.
Persons with access to the internet ACTION: Notice of availability.
may obtain the guidance at either ADDRESSES: To ensure comments on the
https://www.fda.gov/Drugs/Guidance SUMMARY: The Food and Drug information collection are received,
Administration (FDA or Agency) is OMB recommends that written
ComplianceRegulatoryInformation/
announcing the availability of a comments be faxed to the Office of
Guidances/default.htm, https://
guidance for industry entitled ‘‘Drug Information and Regulatory Affairs,
www.fda.gov/BiologicsBloodVaccines/
and Device Manufacturer OMB, Attn: FDA Desk Officer, Fax: 202–
GuidanceComplianceRegulatory Communications With Payors, 395–7285, or emailed to oira_
Information/Guidances/default.htm, Formulary Committees, and Similar submission@omb.eop.gov. All
https://www.fda.gov/MedicalDevices/ Entities—Questions and Answers.’’ This comments should be identified with the
DeviceRegulationandGuidance/ guidance provides answers to common OMB control number 0910-New and
GuidanceDocuments/default.htm, questions regarding the communication title ‘‘Recommendations for Drug and
https://www.fda.gov/AnimalVeterinary/ of health care economic information (d) Device Manufacturer Communications
GuidanceComplianceEnforcement/ about approved prescription drugs and With Payors, Formulary Committees,
GuidanceforIndustry/default.htm, or approved or cleared medical devices by and Similar Entities.’’ Also include the
https://www.regulations.gov. medical product manufacturers, FDA docket number found in brackets
Dated: June 7, 2018. packers, distributers, and their in the heading of this document.
representatives (firms) to payors, You may submit either electronic or
Leslie Kux,
formulary committees, or other similar written comments on Agency guidances
Associate Commissioner for Policy. entities with knowledge and expertise at any time as follows:
[FR Doc. 2018–12631 Filed 6–12–18; 8:45 am] in the area of health care economic
BILLING CODE 4164–01–P analysis (collectively referred to as Electronic Submissions
payors). This guidance also provides Submit electronic comments in the
answers to common questions about following way:
both firms’ dissemination of information • Federal eRulemaking Portal:
amozie on DSK3GDR082PROD with NOTICES1
to payors about medical products that https://www.regulations.gov. Follow the
are not yet approved or cleared for any instructions for submitting comments.
use and firms’ dissemination of Comments submitted electronically,
information to payors about unapproved including attachments, to https://
uses of approved or cleared medical www.regulations.gov will be posted to
products. The Agency is issuing this the docket unchanged. Because your
guidance to explain FDA’s current comment will be made public, you are
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Document Created: 2018-06-12 23:58:54
Document Modified: 2018-06-12 23:58:54
| 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 | The announcement of the guidance is published in the Federal Register on June 13, 2018. Submit written comments on the collection of information by July 13, 2018. | |
| Contact | Regarding the guidance: Kristin Davis, Office of Policy, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-796-0418; or Elizabeth Pepinsky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3248, Silver Spring, MD 20993-0002, 301- 796-1200; or 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; or Ana Loloei Marsal, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-796-8774; or Thomas Moskal, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-216), Rockville, MD 20855, 240-402-6251. | |
| FR Citation | 83 FR 27602 |
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