83 FR 52484 - Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 201 (October 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 201 (October 17, 2018)
| Page Range | 52484-52487 | |
| FR Document | 2018-22568 |
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)] [Notices] [Pages 52484-52487] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22568] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2613] Presenting Quantitative Efficacy and Risk Information in Direct- to-Consumer Promotional Labeling and Advertisements; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.'' This draft guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the- counter (OTC) animal drugs (collectively promotional materials). FDA is issuing this draft guidance to describe the Agency's recommendations for how manufacturers, distributers, and packers (collectively firms) that include quantitative efficacy or risk information about their drugs in DTC promotional materials can make the language and presentation more consumer-friendly. [[Page 52485]] DATES: Submit either electronic or written comments on the draft guidance by December 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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-2018-D-2613 for ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Draft 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 the 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; or 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; or the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: 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 Tom Moskal, Center for Veterinary Medicine (HFV-216), 7519 Standish Pl., Rockville, MD 20855, 240-402-6251. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.'' This draft guidance describes recommendations for how firms that include quantitative efficacy or risk information about their drugs \1\ in DTC promotional materials can make the language and presentation more consumer-friendly. These recommendations apply to DTC promotional materials covered by this draft guidance regardless of the medium in which they are presented (e.g., print, electronic, audiovisual, broadcast). --------------------------------------------------------------------------- \1\ The term drugs in this guidance refers to prescription human drugs, including prescription biological products, and prescription and OTC animal drugs. --------------------------------------------------------------------------- When describing efficacy and risk information about a drug in promotional materials, firms generally have flexibility with how they present this information so long as the presentation is balanced, truthful, and non-misleading, and complies with other applicable statutory and regulatory requirements. One consideration for firms as they develop DTC promotional materials for their drugs is how to best convey efficacy and risk information in a manner that consumers can easily understand, including whether to use words, numbers, visual graphics, or a combination of these elements. FDA understands that firms may experience challenges in determining how to best present quantitative efficacy or risk information in their DTC promotional materials so that consumers can easily comprehend it and use it to form accurate perceptions about their drugs. For these reasons, FDA is issuing this [[Page 52486]] draft guidance to provide recommendations for presenting quantitative efficacy and risk information in DTC promotional materials and to encourage firms to follow these recommendations when including such information in their DTC promotional materials. The draft guidance covers the following topics for presenting quantitative efficacy and risk information in DTC promotional materials, based on current research findings related to communicating health information: Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies Formatting quantitative efficacy or risk information Using visual aids to illustrate quantitative efficacy or risk information Providing quantitative efficacy or risk information for the treatment group and the control group 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 FDA's recommendations for ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.'' 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 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501- 3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information 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: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors and their representatives (firms) of human prescription drugs, including prescription biological products, and animal prescription and OTC drugs. Burden Estimate: The draft guidance provides recommendations on how firms should present quantitative efficacy and risk information in their DTC promotional materials. Accordingly, the draft guidance recommends a ``third-party disclosure'' that constitutes a ``collection of information'' under the PRA. Specifically, the draft guidance recommends that firms display quantitative efficacy or risk information in specific numeric formats (e.g., absolute frequencies or percentages; whole numbers; denominators with a base of 10) and with appropriate context (e.g., adding absolute frequency presentations to relative frequency presentations); provides formatting considerations for illustrating quantitative efficacy or risk information in a visual aid; and recommends that firms include quantitative efficacy or risk information about the control group when it is provided for the treatment group in DTC promotional materials. According to FDA data, approximately 40,000 FDA-regulated DTC promotional materials are prepared by approximately 404 firms annually, and of these materials, the Agency estimates that approximately 40 percent contain presentations of quantitative efficacy or risk information. Based on this information, FDA estimates that approximately 40 percent (160) firms will disseminate 16,000 DTC promotional materials that contain quantitative efficacy or risk information annually, and therefore may be subject to the third-party disclosures. Based on its experience reviewing FDA-regulated promotional materials for drugs, FDA estimates that it will take firms approximately 2 hours to make the disclosures recommended in the draft guidance if they choose to include quantitative efficacy or risk information in their DTC promotional materials and follow the recommendations of this guidance. 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 disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommended information to be included when firms disseminate 160 100 16,000 2 32,000 promotional materials that contain quantitative efficacy or risk information....................................................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov. [[Page 52487]] Dated: October 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22568 Filed 10-16-18; 8:45 am] BILLING CODE 4164-01-P
![52484 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
heading of this document, into the Rutgers, the State University of New § 60.30, including but not limited to:
‘‘Search’’ box and follow the prompts Jersey, and the USPTO requested FDA’s Must be timely (see DATES), must be
and/or go to the Dockets Management assistance in determining this patent’s filed in accordance with § 10.20, must
Staff, 5630 Fishers Lane, Rm. 1061, eligibility for patent term restoration. In contain sufficient facts to merit an FDA
Rockville, MD 20852. a letter dated February 2, 2018, FDA investigation, and must certify that a
FOR FURTHER INFORMATION CONTACT: advised the USPTO that this human true and complete copy of the petition
Beverly Friedman, Office of Regulatory biological product had undergone a has been served upon the patent
Policy, Food and Drug Administration, regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th
10903 New Hampshire Ave., Bldg. 51, approval of BRINEURA represented the Cong., 2d sess., pp. 41–42, 1984.)
Rm. 6250, Silver Spring, MD 20993, first permitted commercial marketing or Petitions should be in the format
301–796–3600. use of the product. Thereafter, the specified in 21 CFR 10.30.
SUPPLEMENTARY INFORMATION:
USPTO requested that FDA determine Submit petitions electronically to
the product’s regulatory review period. https://www.regulations.gov at Docket
I. Background No. FDA–2013–S–0610. Submit written
II. Determination of Regulatory Review
The Drug Price Competition and Period petitions (two copies are required) to the
Patent Term Restoration Act of 1984 Dockets Management Staff (HFA–305),
FDA has determined that the Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term
BRINEURA is 995 days. Of this time, 20852.
Restoration Act (Pub. L. 100–670)
659 days occurred during the testing
generally provide that a patent may be Dated: October 11, 2018.
phase of the regulatory review period,
extended for a period of up to 5 years Leslie Kux,
while 336 days occurred during the
so long as the patented item (human Associate Commissioner for Policy.
approval phase. These periods of time
drug product, animal drug product,
were derived from the following dates: [FR Doc. 2018–22559 Filed 10–16–18; 8:45 am]
medical device, food additive, or color 1. The date an exemption under BILLING CODE 4164–01–P
additive) was subject to regulatory section 505(i) of the Federal Food, Drug,
review by FDA before the item was and Cosmetic Act (21 U.S.C. 355(i))
marketed. Under these acts, a product’s became effective: August 8, 2014. FDA DEPARTMENT OF HEALTH AND
regulatory review period forms the basis has verified the applicant’s claim that HUMAN SERVICES
for determining the amount of extension the date the investigational new drug
an applicant may receive. application became effective was on Food and Drug Administration
A regulatory review period consists of August 8, 2014.
two periods of time: A testing phase and [Docket No. FDA–2018–D–2613]
2. The date the application was
an approval phase. For human initially submitted with respect to the Presenting Quantitative Efficacy and
biological products, the testing phase human biological product under section Risk Information in Direct-to-
begins when the exemption to permit 351 of the Public Health Service Act (42 Consumer Promotional Labeling and
the clinical investigations of the U.S.C. 262): May 27, 2016. FDA has Advertisements; Draft Guidance for
biological product becomes effective verified the applicant’s claim that the Industry; Availability
and runs until the approval phase biologics license application (BLA) for
begins. The approval phase starts with BRINEURA (BLA 761052) was initially AGENCY: Food and Drug Administration,
the initial submission of an application submitted on May 27, 2016. HHS.
to market the human biological product 3. The date the application was ACTION: Notice of availability.
and continues until FDA grants approved: April 27, 2017. FDA has
permission to market the biological verified the applicant’s claim that BLA SUMMARY: The Food and Drug
product. Although only a portion of a 761052 was approved on April 27, 2017. Administration (FDA or Agency) is
regulatory review period may count This determination of the regulatory announcing the availability of a draft
toward the actual amount of extension review period establishes the maximum guidance for industry entitled
that the Director of USPTO may award potential length of a patent extension. ‘‘Presenting Quantitative Efficacy and
(for example, half the testing phase must However, the USPTO applies several Risk Information in Direct-to-Consumer
be subtracted as well as any time that statutory limitations in its calculations Promotional Labeling and
may have occurred before the patent of the actual period for patent extension. Advertisements.’’ This draft guidance
was issued), FDA’s determination of the In its application for patent extension, provides recommendations for
length of a regulatory review period for this applicant seeks 666 days of patent presenting quantitative efficacy and risk
a human biological product will include term extension. information in direct-to-consumer (DTC)
all of the testing phase and approval promotional labeling and
phase as specified in 35 U.S.C. III. Petitions advertisements for prescription human
156(g)(1)(B). Anyone with knowledge that any of drugs and biological products and
FDA has approved for marketing the the dates as published are incorrect may prescription animal drugs and in DTC
human biologic product BRINEURA submit either electronic or written promotional labeling for over-the-
(cerliponase alfa). BRINEURA is comments and, under 21 CFR 60.24, ask counter (OTC) animal drugs
indicated to slow the loss of ambulation for a redetermination (see DATES). (collectively promotional materials).
in symptomatic pediatric patients 3 Furthermore, as specified in § 60.30 (21 FDA is issuing this draft guidance to
daltland on DSKBBV9HB2PROD with NOTICES
years of age and older with late infantile CFR 60.30), any interested person may describe the Agency’s recommendations
neuronal ceroid lipofuscinosis type 2, petition FDA for a determination for how manufacturers, distributers, and
also known as tripeptidyl peptidase 1 regarding whether the applicant for packers (collectively firms) that include
deficiency. Subsequent to this approval, extension acted with due diligence quantitative efficacy or risk information
the USPTO received a patent term during the regulatory review period. To about their drugs in DTC promotional
restoration application for BRINEURA meet its burden, the petition must materials can make the language and
(U.S. Patent No. 8,029,781) from comply with all the requirements of presentation more consumer-friendly.
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![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices 52487
Dated: October 11, 2018. that if you include your name, contact of comments to public dockets, see 80
Leslie Kux, information, or other information that FR 56469, September 18, 2015, or access
Associate Commissioner for Policy. identifies you in the body of your the information at: https://www.gpo.gov/
[FR Doc. 2018–22568 Filed 10–16–18; 8:45 am] application, that information will be fdsys/pkg/FR-2015-09-18/pdf/2015-
BILLING CODE 4164–01–P posted on https://www.regulations.gov. 23389.pdf.
• If you want to submit an Docket: For access to the docket, go to
application with confidential https://www.regulations.gov and insert
DEPARTMENT OF HEALTH AND information that you do not wish to be the docket number, found in brackets in
HUMAN SERVICES made available to the public, submit the the heading of this document, into the
application as a written/paper ‘‘Search’’ box and follow the prompts
Food and Drug Administration submission and in the manner detailed and/or go to the Dockets Management
[Docket No. FDA–2013–N–1018]
(see ‘‘Written/Paper Submissions’’ and Staff, 5630 Fishers Lane, Rm. 1061,
‘‘Instructions’’). Rockville, MD 20852 between 9 a.m.
Isachi Gil; Denial of Hearing; Final Written/Paper Submissions and 4 p.m., Monday through Friday.
Debarment Order Publicly available submissions may be
Submit written/paper submissions as seen in the docket.
AGENCY: Food and Drug Administration, follows:
• Mail/Hand delivery/Courier (for FOR FURTHER INFORMATION CONTACT:
HHS.
written/paper submissions): Dockets Rachael V. Linowes, Office of Scientific
ACTION: Notice.
Management Staff (HFA–305), Food and Integrity, Food and Drug
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Administration, 10903 New Hampshire
Administration (FDA) is denying Isachi Lane, Rm. 1061, Rockville, MD 20852. Ave., Bldg. 1, Rm. 4206, Silver Spring,
Gil’s (Gil’s) request for a hearing and • For a written/paper application MD 20993, 240–402–5931.
issuing an order under the Federal submitted to the Dockets Management SUPPLEMENTARY INFORMATION:
Food, Drug, and Cosmetic Act (FD&C Staff, FDA will post your application, as
Act) debarring Gil for 6 years from I. Background
well as any attachments, except for
providing services in any capacity to a information submitted, marked and Section 306(b)(2)(B)(ii)(I) of the FD&C
person that has an approved or pending identified, as confidential, if submitted Act (21 U.S.C. 335a(b)(2)(B)(ii)(I))
drug product application. FDA bases as detailed in ‘‘Instructions.’’ permits FDA to debar an individual if it
this order on findings that Gil was Instructions: Your application must finds that the individual: (1) Has been
convicted of 12 felonies under Federal include the Docket No. FDA–2013–N– convicted of a felony that involves
Law involving fraud or falsification and 1018. An application will be placed in bribery, payment of illegal gratuities,
that Gil has demonstrated a pattern of the docket and, unless submitted as fraud, perjury, false statement,
conduct sufficient to find that there is ‘‘Confidential Submissions,’’ publicly racketeering, blackmail, extortion,
reason to believe she may violate viewable at https://www.regulations.gov falsification or destruction of records, or
requirements under the FD&C Act or at the Dockets Management Staff interference with, obstruction of an
relating to drug products. In between 9 a.m. and 4 p.m., Monday investigation into, or prosecution of, any
determining the appropriateness and through Friday. criminal offense and (2) based on the
period of Gil’s debarment, FDA • Confidential Submissions—To conviction and other information, has
considered the relevant factors listed in submit an application with confidential demonstrated a pattern of conduct
the FD&C Act. Gil failed to file with the information that you do not wish to be sufficient to find that there is reason to
Agency information and analyses made publicly available, submit your believe that the person may violate
sufficient to create a basis for a hearing application only as a written/paper requirements under the FD&C Act
concerning this action. submission. You should submit two relating to drug products.
DATES: This order is applicable October copies total. One copy will include the On May 24, 2011, a jury found Gil
17, 2018. information you claim to be confidential guilty of 12 felonies. On September 28,
ADDRESSES: Any application for with a heading or cover note that states 2011, the U.S. District Court for the
termination of debarment by Gil under ‘‘THIS DOCUMENT CONTAINS Southern District of Florida entered
section 306(d) of the FD&C Act CONFIDENTIAL INFORMATION.’’ The judgment against her for five counts of
(application) may be submitted as Agency will review this copy, including felony healthcare fraud, in violation of
follows: the claimed confidential information, in 18 U.S.C. 1347, and seven counts of
its consideration of your application. felony false statements related to
Electronic Submissions The second copy, which will have the healthcare matters, in violation of 18
• Federal eRulemaking Portal: claimed confidential information U.S.C. 1035(a)(2). The court sentenced
https://www.regulations.gov. Follow the redacted/blacked out, will be available Gil to 43 months in prison, with 3 years
instructions for submitting comments. for public viewing and posted on of supervised release.
An application submitted electronically, https://www.regulations.gov. Submit Gil’s convictions stemmed from her
including attachments, to https:// both copies to the Dockets Management work as a registered nurse in the home
www.regulations.gov will be posted to Staff. If you do not wish your name and health field. From around March 14,
the docket unchanged. Because your contact information to be made publicly 2007, through about July 15, 2009, Gil
application will be made public, you are available, you can provide this worked as a registered nurse, employed
solely responsible for ensuring that your information on the cover sheet and not by a nursing staffing company and local
daltland on DSKBBV9HB2PROD with NOTICES
application does not include any in the body of your application and you home health agencies. During this time,
confidential information that you or a must identify this information as Gil knowingly and willfully submitted
third party may not wish to be posted, ‘‘confidential.’’ Any information marked and caused the submission of false and
such as medical information, your or as ‘‘confidential’’ will not be disclosed fraudulent claims to Medicare, seeking
anyone else’s Social Security number, or except in accordance with 21 CFR 10.20 reimbursement for various home health
confidential business information, such and other applicable disclosure law. For services she had not provided.
as a manufacturing process. Please note more information about FDA’s posting Specifically, Gil falsified and caused
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Document Created: 2018-10-17 01:48:28
Document Modified: 2018-10-17 01:48:28
| 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 | Submit either electronic or written comments on the draft guidance by December 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | 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 Tom Moskal, Center for Veterinary Medicine (HFV-216), 7519 Standish Pl., Rockville, MD 20855, 240-402-6251. | |
| FR Citation | 83 FR 52484 |
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