82 FR 44803 - Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 185 (September 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 185 (September 26, 2017)
| Page Range | 44803-44807 | |
| FR Document | 2017-20521 |
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)] [Notices] [Pages 44803-44807] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20521] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5319] Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use. DATES: The public hearing will be held on November 16, 2017, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons seeking to attend or to present at the public hearing must register by October 26, 2017. Sections II and III provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until January 15, 2018. Late, untimely filed comments will not be considered. ADDRESSES: The public hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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 [[Page 44804]] 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-2017-N-5319 for ``Devices Referencing Drugs; Public Hearing; Request for Comments.'' 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. FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Associate Director for Policy, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Medical products are often intended and labeled for use in conjunction with other medical products marketed by different sponsors (as used in this document, ``sponsor'' includes an applicant or manufacturer). In some cases, the medical products are of different types (such as drug and device, biological product and device, or drug and biological product). Typically, the different sponsors collaborate when the two products are to be used together for a new intended use. In some cases, products intended for use with one another comprise a ``combination product'' as the term is defined in 21 CFR 3.2(e). Regardless of whether the products meet the definition of a combination product, collaboration between the sponsors can facilitate product development and obtaining marketing authorization for the products for the combined use, and can, thereby, enable access to innovative treatment options for patients. Inclusion of the combined use in the labeling of both products helps ensure user understanding, and the collaboration can also be important to ensuring the ongoing safety and effectiveness of the products for the combined use. Sometimes, however, sponsors seek marketing authorization from FDA for a medical product for a new use with the approved, marketed medical product of another sponsor (i.e., not included in the labeling for the approved, marketed product), and the sponsor of the approved, marketed product does not wish to pursue the new use or work with the other product sponsor. Generally, such proposed products have been devices proposing new uses with approved, marketed drugs (referred to in this notice as devices referencing drugs or DRDs), though other scenarios have been proposed as well, such as drugs proposed for new uses with cleared or approved, marketed devices. This notice focuses on DRDs. In FDA's experience, DRDs may be proposed: (1) To enhance the safety or effectiveness of the marketed drug for its already approved indication; (2) for use with the approved drug for an indication for which the drug is not approved; or (3) to provide some other benefit, such as increasing user comfort or convenience. Such new uses have generally also involved a change in how the drug is used or administered, such as a change in dose, route, or rate of administration. FDA seeks to ensure that safe and effective medical products can be brought onto the market in a timely manner. The Agency encourages development of products that advance public health, particularly those that significantly improve the safety or effectiveness of an existing treatment or that address an unmet medical need. DRDs have the potential to advance the public health by offering new uses with approved, marketed drugs that might not otherwise be developed, because the drug sponsor does not wish to pursue the new use. At the same time, DRDs raise unique public health, scientific, regulatory, and legal issues. FDA, in cooperation with the Drug Information Association, held a public meeting in 2005 on combined uses of separately distributed products.\1\ That meeting focused on the public health, legal, regulatory, and scientific issues \2\ that arise when sponsors seek to develop or market a product of one type (device, drug, or biological product) that would be labeled for use with an approved product of a different type, where the proposed use is not included in the labeling for the approved product. --------------------------------------------------------------------------- \1\ Links to the Federal Register notice for the workshop, presentations given, and a full transcript of the proceedings are available at: https://www.fda.gov/combinationproducts/meetingsconferencesworkshops/ucm116623.htm. \2\ Although the issues discussed at the meeting were described as public health or legal issues, they also included scientific and regulatory issues. --------------------------------------------------------------------------- As reflected in the notice for that meeting and the presentations and discussions at the meeting, devices intended for a new combined use with a drug raise unique public health, scientific, regulatory and legal issues when the sponsors for the two products do not work together on the new combined use of the two products. Since that time, FDA has gained greater experience with these issues and believes that many of these issues for DRDs could be addressed under the approach described below. FDA wishes to obtain further public input through a more focused hearing [[Page 44805]] on the Agency's potential approach for premarket review of proposed DRDs. The Agency is seeking this type of public engagement because of the potential importance of the issue for the public health and the need for input across the medical product industry and among public health stakeholders regarding how FDA should proceed. II. Purpose and Scope of the Public Hearing The purpose of the public hearing is to obtain comment from stakeholders on the potential approach described below, for premarket review of DRDs. As described above, DRDs, for purposes of this document and hearing, are devices that are intended for a use with an approved, marketed drug that is not in the labeling for the approved drug, where the drug application is held by a different sponsor that does not wish to pursue or collaborate on the new use with the device sponsor. The approach described below might be appropriate, for example, for drug delivery systems seeking to be labeled for use with an approved drug, for an indication for which that drug has not been approved (e.g., to administer the drug to treat a different disease or condition or a new patient population). We also welcome comment on any public health, scientific, regulatory, or legal considerations relating to DRDs and other medical products seeking to be labeled for new uses with approved, marketed medical products of a different type where the sponsor for the approved, marketed product does not wish to pursue or collaborate on the new use. The comments that FDA receives from this public hearing may help inform the further development of this approach. A. A Potential Approach for Premarket Review of DRDs FDA strongly recommends collaboration between sponsors on new combined uses of their medical products. The Agency is prepared to work with sponsors to facilitate such collaboration. When sponsors work together, they usually have an ongoing relationship that enables them to resolve many of the public health, scientific, regulatory, and legal issues that may arise as a result of two products being the responsibility of two independent sponsors. Such collaboration also can provide important information to support a regulatory decision (see below). Where collaboration between sponsors is not feasible, for example, because one sponsor does not wish to collaborate, FDA believes that the following factors could help address many of the public health, scientific, regulatory, and legal issues associated with DRDs. In doing so, these factors could allow for a DRD to be reviewed and approved via a device premarket authorization pathway \3\ without approval of conforming labeling changes for the approved, marketed drug through a new drug application (NDA) or supplement to an NDA (see Section II.B Submission Considerations for further discussion). --------------------------------------------------------------------------- \3\ FDA has not determined at this time whether DRDs may be reviewed through other device premarket authorization pathways besides premarket approval applications (PMAs), but FDA intends to consider this issue and welcomes comment on it. --------------------------------------------------------------------------- B. Factors DRD sponsors should be able to address the following issues as discussed below: 1. Safety and Effectiveness of the New Use of the Drug. The DRD sponsor is able to demonstrate the safety and effectiveness of the new use of the drug that is included in the DRD labeling, by providing substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use described in the proposed DRD labeling and showing that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed DRD labeling, as this is the standard that applies to new uses of drugs (see 21 U.S.C. 355(c) and (d)). If there are multiple approved versions of the approved drug product(s) referenced in the DRD labeling (including generic versions), the DRD sponsor is able to demonstrate the generalizability of the new use with all such versions of the drug product. 2. User Confusion and Medication Error/Use Error. Given the potential for user confusion or medication error/use error, for example, due to certain differences in the labeling for the DRD and the approved drug that it is referencing, the DRD sponsor is able to demonstrate that the potential for user confusion or error has been adequately addressed. The DRD labeling must provide adequate directions for the new use with the approved, marketed drug. 3. Postmarket Change Management. The DRD sponsor is able to demonstrate that it is able to address safety or effectiveness issues associated with changes to the approved, marketed drug, for example, by demonstrating: That the likelihood of changes to the approved, marketed drug is low; changes to the drug are unlikely to raise safety or effectiveness issues with respect to the conditions of use with the drug as described in the DRD labeling; and periodic testing will be conducted and be adequate to assure ongoing safety and effectiveness of the combined use. It is important that these issues be addressed because the DRD sponsor does not have a relationship with the sponsor for the approved, marketed drug, and, therefore, any changes to the two products will not be coordinated or communicated in advance. 4. Postmarket Safety. The DRD sponsor is able to demonstrate that it has a postmarket safety plan to adequately address adverse events, including medication errors, related to the drug when used with the DRD. It is important that its postmarket safety plan allows the DRD sponsor to adequately capture, report, and respond appropriately to adverse events associated with the new drug use described in the DRD labeling, because the DRD sponsor does not have a relationship with the sponsor(s) of the approved, marketed drug and because the DRD sponsor will often be uniquely positioned to understand and address adverse events resulting from the new use of the drug described in the DRD labeling. 5. Data Reliance. The DRD sponsor is able to provide all information needed to evaluate the safety and effectiveness of the new use with the approved drug referenced in the DRD labeling, without relying on any proprietary information for the approved drug (e.g., by instead relying on non-product-specific published literature, generalizable knowledge). The DRD sponsor may also be able to include in its application safety and effectiveness data and information from the marketing application for the drug that are publicly available, for example, if the approved reference listed drug has been withdrawn from sale, provided that FDA has determined that the approved reference listed drug was not withdrawn from sale for reasons of safety or effectiveness (see 21 U.S.C. 355(l) and 21 CFR 314.161 and 314.430). Generally, a DRD sponsor would not have a right of reference to proprietary information on the approved drug with which the DRD is proposed to be used because the DRD sponsor has no relationship with the sponsor of the approved drug. C. Submission Considerations At the investigational stage, depending on the details of the investigational plan, a DRD sponsor may seek to submit an investigational new drug application (IND) or an investigational device exemption application (IDE). Either way, the Center for Drug Evaluation and Research [[Page 44806]] (CDER) and the Center for Devices and Radiological Health (CDRH) would collaborate on the review. DRD sponsors should consult with CDER and CDRH as to which application to submit for a particular investigation. FDA believes that a PMA would generally be the appropriate device marketing application because, e.g., DRDs are expected to represent a new intended use or raise different questions of safety or effectiveness as compared to a legally marketed predicate device. Generally, PMAs for DRDs would be reviewed by CDRH, and CDRH would collaborate with CDER on the review of the DRD. CDRH would have the lead on device-specific issues, and CDER would have the lead on drug- specific issues. The Centers would identify any review aspects where review considerations overlap, to ensure Agency alignment on how to address these considerations and communicate about them to DRD sponsors. D. Questions for Commenters To Address FDA welcomes all feedback on the potential approach and on any public health, scientific, regulatory, and legal issues raised by it. We seek public comment on the factors and submission considerations described in this notice, and propose the following questions in an effort to prompt substantive input from stakeholders: 1. Are there public health, scientific, regulatory, or legal issues that should be considered with respect to this potential approach for DRDs? If so, are there ways to address those issues? 2. Is each of the factors and submission considerations described above appropriate? If not, why not? What modifications would you propose and why? Are there additional factors or submission considerations that the Agency should take into account? Please provide examples to illustrate your view. 3. Should the approach described in this notice be limited to certain situations, such as where the combined use would potentially address an unmet medical need for a serious or life-threatening condition? If so, please provide a detailed analysis in support of your view, including its legal justification. 4. With respect to the user confusion and medication error/use error factor, are there other issues that DRD sponsors should address or that FDA should consider, to ensure that the DRD labeling provides adequate directions for the new use with the approved, marketed drug, without approval of conforming labeling changes for the approved, marketed drug? What issues should be considered with respect to promotional activities by the DRD sponsor and/or by any sponsors for the drug being referenced? 5. With regard to the postmarket change management factor, what would be examples of circumstances in which the DRD sponsor would be able to adequately address this factor? What types of postmarket changes to the drug should the DRD sponsor be prepared to identify and address? What postmarket mechanisms, including specific testing or monitoring, would be appropriate to ensure ongoing safety and effectiveness of the combined use? 6. When multiple versions of the drug, including generics, are marketed, what challenges exist in identifying which versions of the drug can be used with the DRD? How can DRD sponsors make this information clear to health care providers, pharmacists, and patients? 7. What challenges exist at the investigational application stage, and how can those challenges be addressed? Are there circumstances where an IND would be the more appropriate investigational application for a clinical investigation of a DRD? Are there circumstances where an IDE would be the more appropriate investigational application? 8. How may this approach impact future product development? 9. Would an approach similar to the potential approach presented in this notice be appropriate for other types of combined uses (e.g., drugs referencing devices where the device sponsor does not wish to collaborate on the new use)? If so, how should the factors, submission considerations, or both be modified for other types of combined uses? Are there additional factors that should be considered for other types of combined uses? 10. Are there other possible approaches that may be used to seek marketing authorization for combined uses of drugs and devices where product sponsors are unable or unwilling to collaborate? Please provide a detailed analysis in support of your proposed approach, including its legal justification. 11. Recognizing that collaboration is preferable, what actions can FDA and stakeholders take to encourage and facilitate collaboration between device sponsors and sponsors of approved, marketed drugs to develop new combined uses of their medical products? 12. Would an approach similar to the potential approach presented in this notice be appropriate in the case where a drug sponsor would like to include in the drug labeling the use of one or more approved or cleared companion diagnostics for its new drug in the same class as the drugs for which the companion diagnostic is approved or cleared but none of the companion diagnostic sponsors intend to add the new drug to the device labeling? If so, how should the factors, submission considerations, or both be modified? Are there additional factors that should be considered? Are there other possible approaches that may be used for such circumstance? Please provide a detailed analysis in support of your proposed approach, including its legal justification. III. Registration Registration and Requests for Oral Presentations: The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance will be free and on a first-come, first-served basis. If you wish to attend (either in person or by webcast (see Streaming Webcast of the Public Hearing)) and/or present at the hearing, please register for the hearing and/or make a request for oral presentations or comments at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm by October 26, 2017 and provide complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). Those without email access can register by contacting John Barlow Weiner by October 26, 2017 (see FOR FURTHER INFORMATION CONTACT). FDA will try to accommodate all persons who wish to make a presentation. Individuals wishing to present should identify the number of the question, or questions, they wish to address. This will help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak. Once FDA notifies registered presenters of their scheduled times, they are encouraged to submit an electronic copy of their presentation to [email protected] on or before November 2, 2017. Persons registered to make an oral presentation are encouraged to arrive at the hearing room early and check in at the onsite registration table to confirm their designated presentation time. An [[Page 44807]] agenda for the hearing and any other background materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm. If you need special accommodations because of a disability, please contact the Office of Combination Products at 301-796-8930 or [email protected] at least 7 days before the hearing. Streaming Webcast of the Public Hearing: For those unable to attend in person, FDA will provide a live webcast of the hearing. To join the hearing via the webcast, please go to https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at https://www.fda.gov. IV. Notice of Hearing Under 21 CFR Part 15 The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with 21 CFR part 15. The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research. Under Sec. 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may pose questions; they may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under Sec. 10.205, representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in Sec. 15.30(b) (see Transcripts). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in Sec. 15.30(h). Dated: September 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20521 Filed 9-25-17; 8:45 am] BILLING CODE 4164-01-P
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that are available to FDA at the time the continue to address the issue on a case- SUMMARY: The Food and Drug
classification determination is made. by-case, fact-specific basis as needed, in Administration (FDA or the Agency) is
FDA regularly receives questions from a transparent manner as permitted by, announcing a public hearing on a
medical product sponsors concerning and consistent with, applicable legal potential approach for device sponsors
the classification of their products. We requirements. Any stakeholder who has who seek to obtain marketing
believe that efficient, effective questions regarding the classification of authorization for their products that are
regulation would be facilitated by a currently marketed product or labeled for a new use with an approved,
providing guidance on this topic. This whether that classification should be marketed drug when the sponsor for the
guidance discusses the request for relied upon with respect to a proposed approved drug does not wish to pursue
designation (RFD) process for obtaining product is encouraged to contact the or collaborate on the new use.
a formal determination of a product’s Office of Combination Products. DATES: The public hearing will be held
classification, and provides general on November 16, 2017, from 9 a.m. to
concepts regarding FDA’s decision II. Significance of Guidance
5 p.m. The public hearing may be
process for making classification This guidance is being issued extended or may end early depending
determinations. While issues have consistent with FDA’s good guidance on the level of public participation.
arisen relating to whether a product practices regulation (21 CFR 10.115). Persons seeking to attend or to present
should be classified as a drug, device, The guidance represents the current at the public hearing must register by
biological product, or combination thinking of FDA on ‘‘Classification of October 26, 2017. Sections II and III
product, issues most frequently arise Products as Drugs and Devices & provides attendance and registration
regarding whether a product should be Additional Product Classification information. Electronic or written
classified as either a drug or a device. Issues.’’ It does not establish any rights comments will be accepted after the
Accordingly, this guidance focuses for any person and is not binding on public hearing until January 15, 2018.
particularly on cases in which a product FDA or the public. You can use an Late, untimely filed comments will not
may be classified as a drug or device. alternative approach if it satisfies the
This guidance is organized into two be considered.
requirements of the applicable statutes
substantive sections. Section II provides ADDRESSES: The public hearing will be
and regulations. This guidance is not
information on the RFD process for held at the FDA White Oak Campus,
subject to Executive Order 12866.
obtaining a formal determination of 10903 New Hampshire Ave., Building
whether a product is classified as a drug III. Paperwork Reduction Act of 1995 31 Conference Center, the Great Room
or device and on obtaining other This guidance refers to previously (Rm. 1503, Section A), Silver Spring,
feedback from FDA on product approved collections of information MD 20993–0002. Entrance for the public
classification questions. Section III found in FDA regulations. These hearing participants (non-FDA
discusses general concepts and collections of information are subject to employees) is through Building 1, where
definitions relating to FDA’s decisional review by the Office of Management and routine security check procedures will
process for making classification Budget (OMB) under the Paperwork be performed. For parking and security
determinations and addresses issues Reduction Act of 1995 (44 U.S.C. 3501– information, please refer to https://
that may arise in determining whether 3520). The collections of information in www.fda.gov/AboutFDA/Working
products should be classified as drugs 21 CFR part 3 have been approved atFDA/BuildingsandFacilities/White
or devices. under OMB control number 0910–0523. OakCampusInformation/
FDA carefully considered the ucm241740.htm.
comments received on the two draft IV. Electronic Access
Electronic Submissions
guidances in preparing this final Persons with access to the internet
guidance. We have combined the two Submit electronic comments in the
may obtain the document at https://
documents into one and made other following way:
www.fda.gov/RegulatoryInformation/
changes for clarity and ease of reference. • Federal eRulemaking Portal:
Guidances/ucm258946.htm.
For example, we have revised the https://www.regulations.gov. Follow the
discussion of the Agency’s Dated: September 21, 2017. instructions for submitting comments.
interpretation and application of the Anna K. Abram, Comments submitted electronically,
term ‘‘chemical action’’ in the definition Deputy Commissioner for Policy, Planning, including attachments, to https://
of device at section 201(h) of the FD&C Legislation, and Analysis. www.regulations.gov will be posted to
Act, to more clearly explain the [FR Doc. 2017–20522 Filed 9–25–17; 8:45 am] the docket unchanged. Because your
Agency’s approach. With regard to this BILLING CODE 4164–01–P comment will be made public, you are
issue and others, we have also included solely responsible for ensuring that your
additional examples to illustrate the comment does not include any
application of the Agency’s current DEPARTMENT OF HEALTH AND confidential information that you or a
thinking. HUMAN SERVICES third party may not wish to be posted,
In light of comments received, we such as medical information, your or
have also reconsidered inclusion of Food and Drug Administration anyone else’s Social Security number, or
content on the status of prior Agency confidential business information, such
classification determinations. FDA has [Docket No. FDA–2017–N–5319] as a manufacturing process. Please note
had limited experience with that if you include your name, contact
reevaluating classification Devices Proposed for a New Use With information, or other information that
determinations as the issue rarely arises an Approved, Marketed Drug; Public identifies you in the body of your
for FDA to consider. In addition, it can Hearing; Request for Comments comments, that information will be
raise a variety of complex scientific and AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
regulatory questions. Accordingly, we HHS. • If you want to submit a comment
have concluded that it is not with confidential information that you
ACTION: Notification of public hearing;
appropriate to address the topic further do not wish to be made available to the
request for comments.
in guidance at this time. We will public, submit the comment as a
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agenda for the hearing and any other acts as a waiver of those provisions as coders, public health experts,
background materials will be made specified in § 15.30(h). individuals affiliated with academic
available 5 days before the hearing at Dated: September 19, 2017. institutions, research and development
https://www.fda.gov/NewsEvents/ Anna K. Abram, communities in the private sector, and
MeetingsConferencesWorkshops/ others. All submissions will be
Deputy Commissioner for Policy, Planning,
ucm572528.htm. Legislation, and Analysis. evaluated and separate prizes will be
If you need special accommodations awarded for each of the three phases
[FR Doc. 2017–20521 Filed 9–25–17; 8:45 am]
because of a disability, please contact below.
BILLING CODE 4164–01–P
the Office of Combination Products at Phase 1: Design
301–796–8930 or combination@fda.gov Phase 2: Development and Small Scale
at least 7 days before the hearing. Testing
Streaming Webcast of the Public DEPARTMENT OF HEALTH AND
HUMAN SERVICES Phase 3: Scaling
Hearing: For those unable to attend in Estimated dates for each phase are as
person, FDA will provide a live webcast Health Resources and Services follows:
of the hearing. To join the hearing via Administration
the webcast, please go to https:// Phase 1: Effective on January 22, 2018
www.fda.gov/NewsEvents/Meetings Phase 1 Submission Period Ends: April
COMPETES Reauthorization Act
ConferencesWorkshops/ 20, 2018, 11:59 p.m. ET
Challenge Competition
ucm572528.htm. Phase 1 Judging Period: April 21–May
Transcripts: Please be advised that as AGENCY: Health Resources and Services 18, 2018
soon as a transcript is available, it will Administration, Department of Health Phase 1 Winners Announced: May 25,
be accessible at https:// and Human Services. 2018
www.regulations.gov. It may be viewed ACTION: Notice. Phase 2 Begins: May 29, 2018
at the Dockets Management Staff (see Phase 2 Submission Period Ends:
SUMMARY: The Health Resources and October 26, 2018
ADDRESSES). A transcript will also be
Services Administration’s (HRSA’s) Phase 2 Judging Period: October 29–
available in either hard copy or on CD–
Maternal and Child Health Bureau November 20, 2018
ROM, after submission of a Freedom of
Information request. The Freedom of (MCHB) announces a prize competition Phase 2 Winners Announced: December
Information office address is available to support the development and testing 4, 2018
on the Agency’s Web site at https:// of low-cost, scalable technology-based Phase 3 Begins: December 7, 2018
www.fda.gov. innovations to meet the needs of Phase 3 Submission Period Ends: May
families and health care providers of 10, 2019
IV. Notice of Hearing Under 21 CFR children with special health care needs Phase 3 Winner Announced: May 30,
Part 15 (CSHCN), particularly children with 2019
The Commissioner of Food and Drugs medical complexity (CMC), to improve
the quality of care, patient Subject of Challenge Competition
is announcing that the public hearing
will be held in accordance with 21 CFR empowerment, and family experiences MCHB is sponsoring the Making
part 15. The hearing will be conducted while saving costs to the health care Technology Work for Care Planning and
by a presiding officer, who will be system. Coordination for Children with Special
accompanied by FDA senior FOR FURTHER INFORMATION CONTACT: Health Care Needs Challenge. CSHCN,
management from the Office of the James Resnick, Office of the Associate particularly CMC, often rely on multiple
Commissioner, the Center for Drug Administrator, MCHB, JResnick@ systems, services, and health
Evaluation and Research, the Center for hrsa.gov, (301) 443–3222, or Marie professionals to maintain health and
Devices and Radiological Health, and Mann, Division of Services for Children optimize well-being. Care coordination
the Center for Biologics Evaluation and with Special Health Needs, MCHB, and care planning centered on the
Research. Under § 15.30(f), the hearing MMann@hrsa.gov, (301) 443–4925. comprehensive needs of the child and
is informal and the rules of evidence do SUPPLEMENTARY INFORMATION: On family can lead to improved quality and
not apply. No participant may interrupt January 4, 2011, the America experience of care, as well as more cost-
the presentation of another participant. COMPETES Reauthorization Act of 2010 effective care. Even with the presence of
Only the presiding officer and panel was signed into law allowing the use of care coordinators and the development
members may pose questions; they may challenges and prize competitions of shared care plans, communication
question any person during or at the increasing agencies’ ability to promote and collaboration gaps remain because
conclusion of each presentation. Public and harness innovation. Competitions care coordinators and the shared care
hearings under part 15 are subject to run by the federal government result in plans often are specific to providers
FDA’s policy and procedures for a number of benefits to the public, and/or systems. Families have
electronic media coverage of FDA’s including the following: expressed frustration about working
public administrative proceedings (21 (a) Increasing the number and with the multiple systems and the lack
CFR part 10, subpart C). Under § 10.205, diversity of the individuals, teams, and of communication and coordination
representatives of the media may be organizations that are addressing a between them. They try to address the
permitted, subject to certain limitations, particular problem or challenge of gap by assuming responsibility for their
to videotape, film, or otherwise record national significance; children’s 24/7 care and care
FDA’s public administrative (b) Improving the skills of the coordination. However, they often
proceedings, including presentations by participants in the competition; and encounter numerous obstacles and
participants. The hearing will be (c) Directing attention to new market barriers to fulfilling this role, including
transcribed as stipulated in § 15.30(b) opportunities and stimulating private difficulty obtaining needed information
(see Transcripts). To the extent that the sector investment. or guidance from health professionals.
conditions for the hearing, as described This challenge structured in three They desire resources like electronic
in this notice, conflict with any phases, reach a diverse population of and informational tools to allow easy
provisions set out in part 15, this notice innovators and solvers, including aggregation of information and sharing
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Document Created: 2017-09-26 02:48:59
Document Modified: 2017-09-26 02:48:59
| 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 | Notification of public hearing; request for comments. | |
| Dates | The public hearing will be held on November 16, 2017, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons seeking to attend or to present at the public hearing must register by October 26, 2017. Sections II and III provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until January 15, 2018. Late, untimely filed comments will not be considered. | |
| Contact | John Barlow Weiner, Associate Director for Policy, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, [email protected] | |
| FR Citation | 82 FR 44803 |
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