82_FR_13680 82 FR 13632 - Enhancing Patient Engagement Efforts Across the Food and Drug Administration; Establishment of a Public Docket; Request for Comments

82 FR 13632 - Enhancing Patient Engagement Efforts Across the Food and Drug Administration; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 48 (March 14, 2017)

Page Range13632-13634
FR Document2017-04982

The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit input on ongoing efforts to enhance mechanisms for patient engagement at the Agency. Engaging with patients, their caregivers, and advocates has long been a priority of the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. This concept was directly informed by the public feedback solicited through the prior public docket regarding FDA's stakeholder engagement responsibilities outlined by the Food and Drug Administration Safety and Innovation Act (FDASIA). The purpose of this notice is to outline FDA's proposal for the future of patient engagement at the Agency so that the perspectives of patient communities can be better captured.

Federal Register, Volume 82 Issue 48 (Tuesday, March 14, 2017) 
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13632-13634]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0455]


Enhancing Patient Engagement Efforts Across the Food and Drug 
Administration; Establishment of a Public Docket; Request for Comments

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to solicit input on ongoing efforts to 
enhance mechanisms for patient engagement at the Agency. Engaging with 
patients, their caregivers, and advocates has long been a priority of 
the Agency. In this tradition, FDA intends to enhance future patient 
engagement by providing a more transparent, accessible, and robust 
experience for patient communities. To achieve these goals, FDA is 
considering establishing a new Office of Patient Affairs. This concept 
was directly informed by the public feedback solicited through the 
prior public docket regarding FDA's stakeholder engagement 
responsibilities outlined by the Food and Drug Administration Safety 
and Innovation Act (FDASIA). The purpose of this notice is to outline 
FDA's proposal for the future of patient engagement at the Agency so 
that the perspectives of

[[Page 13633]]

patient communities can be better captured.

DATES: Submit either electronic or written comments by June 12, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-0455 for '' Enhancing Patient Engagement Efforts Across FDA; 
Establishment of a Public Docket; 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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sharnell Ligon, Office of Medical 
Products and Tobacco, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993, 301-796-5253, FAX: 
301-847-3532.

SUPPLEMENTARY INFORMATION: FDA has long recognized the importance of 
engaging with patients, caregivers, and their advocates in the medical 
product development process. On July 9, 2012, the President signed into 
law FDASIA (Pub. L. 112-144), which expands FDA's authorities and 
strengthens the Agency's ability to safeguard and advance public health 
in several areas, including increasing stakeholder involvement in FDA 
regulatory processes. Section 1137 of FDASIA, Patient Participation in 
Medical Product Discussions, codified in section 569C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8c), directs the 
Secretary of Health and Human Services to ``develop and implement 
strategies to solicit the views of patients during the medical product 
development process and consider the perspectives of patients during 
regulatory discussions.''
    On November 4, 2014, FDA issued a Federal Register notice 
establishing a docket (FDA-2014-N-1698) for public commenters to submit 
information related to FDA's implementation of FDASIA's Patient 
Participation in Medical Product Discussions under FDASIA section 1137 
(79 FR 65410). In response to public comments, and recognizing a need 
for improved coordination and support for patient engagement across 
medical product centers, the Office of the Commissioner launched an 
effort to enhance mechanisms for patient engagement at FDA.
    As part of this effort, the Agency has identified the following 
objectives for its patient engagement activities:
     Develop a nuanced understanding of the patient experience 
of disease by:
    [cir] Gathering patient perspective on what is clinically 
meaningful,
    [cir] assessing attitudes towards benefit-risk and tolerance of 
uncertainty, and
    [cir] enhancing the science of eliciting and integrating patient 
input.
     Support patients and their advocates in understanding 
regulatory processes and navigating the FDA by:
    [cir] Communicating relevant FDA positions, procedures, and 
activities,
    [cir] connecting patients and their advocates with the appropriate 
resources, and
    [cir] resolving discrete challenges and needs.
    To achieve these objectives, the Agency is considering establishing 
a central ``Office of Patient Affairs'' which will be tasked with 
supporting and coordinating patient engagement activities across 
medical product centers and other offices that engage with patients and 
their advocates on matters pertaining to medical products. In order to 
improve the transparency, coordination, and implementation of FDA's 
patient engagement activities, the responsibilities of this central 
office would include:
     Offering a single, central entry point to the Agency for 
the patient community,
     providing triage and navigation services for inbound 
inquiries from patient stakeholders,
     hosting and maintaining robust data management systems 
that would

[[Page 13634]]

incorporate and formalize knowledge shared with FDA by patient 
stakeholders and FDA's relationships with patient communities, and
     developing a scalable and forward-looking platform for 
communicating with patient stakeholders, particularly online channels.
    Under this proposal to enhance mechanisms for patient engagement at 
FDA, a new ``Office of Patient Affairs'' would be directly accountable 
to the medical product Centers through clear governance structures. In 
addition, a regular evaluation of this central office and of FDA's 
overall patient engagement efforts is proposed. This evaluation will 
include feedback from external stakeholders (including patients and 
their advocates) on a biennial basis to best ensure the Agency's 
ongoing responsiveness to the needs of patient communities.

    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04982 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P

13632 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices TABLE 2—CLASS II DEVICES (§ 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS)— Continued Source Allergen code Allergen product (taxonomical name) k23 .............................. Straw Dust ........................................................................... NA. k33 .............................. Oak ...................................................................................... NA. k70 .............................. Green coffee bean ............................................................... Coffea spp. k71 .............................. Castor bean ......................................................................... Ricinus communis. k72 .............................. Ispaghula ............................................................................. Plantago psyllium/Plantago ovata. k73 .............................. Silk waste ............................................................................. NA. k74 .............................. Silk ....................................................................................... Bombyx mori. k75 .............................. Isocyanate TDI (Toluene diisocyanate) ............................... NA. k76 .............................. Isocyanate MDI (Diphenylmethane diisocyanate) ............... NA. k77 .............................. Isocyanate HDI (Hexamethylen diisocyanate) .................... NA. k78 .............................. Ethylene oxide ..................................................................... NA. k79 .............................. Phthalic anhydride ............................................................... NA. k80 .............................. Formaldehyde/Formalin ....................................................... NA. k81 .............................. Ficus .................................................................................... Ficus benjamina (Ficus spp.). k83 .............................. Cotton seed ......................................................................... Gossypium hirsutum. k84 .............................. Sunflower seed .................................................................... Helianthus annuus. k85 .............................. Chloramin T ......................................................................... NA. k86 .............................. Trimellitic anhydride, TMA ................................................... NA. k87 .............................. Asp o 21, alpha-amylase ..................................................... Aspergillus oryzae. k89 .............................. Orris root .............................................................................. Iris florentina. k99 .............................. HSA (Human Serum Albumin) (Hom s HSA) ...................... Homo sapiens. k201 ............................ Car p 1, Papain ................................................................... Carica papaya. k202 ............................ Ana c 2, Bromelain .............................................................. Ananas comosus. k204 ............................ Maxatase ............................................................................. Bacillus licheniformis. k205 ............................ Alcalase ............................................................................... Bacillus spp. k206 ............................ Savinase, Protease 1 (Bac l Subtilisin) ............................... Bacillus spp. k208 ............................ Gal d 4, Lysozyme ............................................................... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 ............................ Hexahydrophtalic anhydrid .................................................. NA. k210 ............................ Maleic anhydride .................................................................. NA. k211 ............................ Methyltetrahydrophtalic anhydrid ......................................... NA. k212 ............................ Abachi wood dust ................................................................ Triplochiton scleroxylon. k213 ............................ Pepsin (Sus s Pepsin) ......................................................... Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 ............................ TCPA ................................................................................... NA. k214 ............................ Bougainvillea ........................................................................ Bougainvillea spp. k225 ............................ Horse radish peroxidase (Arm r HRP) ................................ Armoracia rusticana. k226 ............................ Ascorbate oxidase (Cuc p ascorbate oxidase) ................... Cucurbita pepo. k301 ............................ Flour dust ............................................................................. Triticum spp. k501 ............................ Savinase customer specific ................................................. Proprietary knowledge of customer. k502 ............................ Lipolase customer specific .................................................. Proprietary knowledge of customer. k503 ............................ Termamyl customer specific ................................................ Proprietary knowledge of customer. k504 ............................ Clazinase customer specific ................................................ Proprietary knowledge of customer. V. Reference Dated: March 8, 2017. input on ongoing efforts to enhance Leslie Kux, mechanisms for patient engagement at The following reference is on display Associate Commissioner for Policy. the Agency. Engaging with patients, in the Division of Dockets Management [FR Doc. 2017–04938 Filed 3–13–17; 8:45 am] their caregivers, and advocates has long (see ADDRESSES) and is available for BILLING CODE 4164–01–P been a priority of the Agency. In this viewing by interested persons between tradition, FDA intends to enhance 9 a.m. and 4 p.m., Monday through future patient engagement by providing Friday; it is also available electronically DEPARTMENT OF HEALTH AND a more transparent, accessible, and at https://www.regulations.gov. FDA has HUMAN SERVICES robust experience for patient verified the Web site address, as of the communities. To achieve these goals, date this document publishes in the Food and Drug Administration FDA is considering establishing a new Federal Register, but Web sites are [Docket No. FDA–2017–N–0455] Office of Patient Affairs. This concept subject to change over time. was directly informed by the public Enhancing Patient Engagement Efforts feedback solicited through the prior asabaliauskas on DSK3SPTVN1PROD with NOTICES 1. FDA Guidance, ‘‘Procedures for Class II Device Exemptions from Premarket Across the Food and Drug public docket regarding FDA’s Notification, Guidance for Industry and Administration; Establishment of a stakeholder engagement responsibilities CDRH Staff,’’ February 19, 1998, Public Docket; Request for Comments outlined by the Food and Drug available at http://www.fda.gov/ ACTION: Notice; request for comments. Administration Safety and Innovation downloads/MedicalDevices/ Act (FDASIA). The purpose of this DeviceRegulationandGuidance/ SUMMARY: The Food and Drug notice is to outline FDA’s proposal for GuidanceDocuments/UCM080199.pdf. Administration (FDA or Agency) is the future of patient engagement at the establishing a public docket to solicit Agency so that the perspectives of VerDate Sep<11>2014 17:42 Mar 13, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1

Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices 13633 patient communities can be better • Confidential Submissions—To Patient Participation in Medical Product captured. submit a comment with confidential Discussions, codified in section 569C of DATES: Submit either electronic or information that you do not wish to be the Federal Food, Drug, and Cosmetic written comments by June 12, 2017. made publicly available, submit your Act (21 U.S.C. 360bbb–8c), directs the comments only as a written/paper Secretary of Health and Human Services ADDRESSES: You may submit comments submission. You should submit two to ‘‘develop and implement strategies to as follows: copies total. One copy will include the solicit the views of patients during the Electronic Submissions information you claim to be confidential medical product development process Submit electronic comments in the with a heading or cover note that states and consider the perspectives of following way: ‘‘THIS DOCUMENT CONTAINS patients during regulatory discussions.’’ CONFIDENTIAL INFORMATION.’’ The On November 4, 2014, FDA issued a • Federal eRulemaking Portal: Agency will review this copy, including Federal Register notice establishing a https://www.regulations.gov. Follow the the claimed confidential information, in docket (FDA–2014–N–1698) for public instructions for submitting comments. its consideration of comments. The commenters to submit information Comments submitted electronically, second copy, which will have the related to FDA’s implementation of including attachments, to https:// claimed confidential information FDASIA’s Patient Participation in www.regulations.gov will be posted to redacted/blacked out, will be available Medical Product Discussions under the docket unchanged. Because your for public viewing and posted on FDASIA section 1137 (79 FR 65410). In comment will be made public, you are https://www.regulations.gov. Submit response to public comments, and solely responsible for ensuring that your both copies to the Division of Dockets recognizing a need for improved comment does not include any Management. If you do not wish your coordination and support for patient confidential information that you or a name and contact information to be engagement across medical product third party may not wish to be posted, made publicly available, you can centers, the Office of the Commissioner such as medical information, your or provide this information on the cover launched an effort to enhance anyone else’s Social Security number, or sheet and not in the body of your mechanisms for patient engagement at confidential business information, such comments and you must identify this FDA. as a manufacturing process. Please note information as ‘‘confidential.’’ Any As part of this effort, the Agency has that if you include your name, contact information marked as ‘‘confidential’’ identified the following objectives for its information, or other information that will not be disclosed except in patient engagement activities: identifies you in the body of your • Develop a nuanced understanding comments, that information will be accordance with 21 CFR 10.20 and other applicable disclosure law. For more of the patient experience of disease by: posted on https://www.regulations.gov. Æ Gathering patient perspective on • If you want to submit a comment information about FDA’s posting of comments to public dockets, see 80 FR what is clinically meaningful, with confidential information that you Æ assessing attitudes towards benefit- do not wish to be made available to the 56469, September 18, 2015, or access the information at: http://www.fda.gov/ risk and tolerance of uncertainty, and public, submit the comment as a Æ enhancing the science of eliciting written/paper submission and in the regulatoryinformation/dockets/ default.htm. and integrating patient input. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to • Support patients and their Submissions’’ and ‘‘Instructions’’). advocates in understanding regulatory read background documents or the Written/Paper Submissions electronic and written/paper comments processes and navigating the FDA by: received, go to https:// Æ Communicating relevant FDA Submit written/paper submissions as positions, procedures, and activities, follows: www.regulations.gov and insert the Æ connecting patients and their • Mail/Hand delivery/Courier (for docket number, found in brackets in the advocates with the appropriate written/paper submissions): Division of heading of this document, into the resources, and Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts Æ resolving discrete challenges and and Drug Administration, 5630 Fishers and/or go to the Division of Dockets needs. Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. To achieve these objectives, the • For written/paper comments 1061, Rockville, MD 20852. Agency is considering establishing a submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: central ‘‘Office of Patient Affairs’’ which Management, FDA will post your Sharnell Ligon, Office of Medical will be tasked with supporting and comment, as well as any attachments, Products and Tobacco, Food and Drug coordinating patient engagement except for information submitted, Administration, 10903 New Hampshire activities across medical product centers marked and identified, as confidential, Ave., Bldg. 51, Rm. 6125, Silver Spring, and other offices that engage with if submitted as detailed in MD 20993, 301–796–5253, FAX: 301– patients and their advocates on matters ‘‘Instructions.’’ 847–3532. pertaining to medical products. In order Instructions: All submissions received SUPPLEMENTARY INFORMATION: FDA has to improve the transparency, must include the Docket No. FDA– long recognized the importance of coordination, and implementation of 2017–N–0455 for ’’ Enhancing Patient engaging with patients, caregivers, and FDA’s patient engagement activities, the Engagement Efforts Across FDA; their advocates in the medical product responsibilities of this central office Establishment of a Public Docket; development process. On July 9, 2012, asabaliauskas on DSK3SPTVN1PROD with NOTICES would include: Request for Comments.’’ Received the President signed into law FDASIA • Offering a single, central entry point comments will be placed in the docket (Pub. L. 112–144), which expands to the Agency for the patient and, except for those submitted as FDA’s authorities and strengthens the community, ‘‘Confidential Submissions,’’ publicly Agency’s ability to safeguard and • providing triage and navigation viewable at https://www.regulations.gov advance public health in several areas, services for inbound inquiries from or at the Division of Dockets including increasing stakeholder patient stakeholders, Management between 9 a.m. and 4 p.m., involvement in FDA regulatory • hosting and maintaining robust data Monday through Friday. processes. Section 1137 of FDASIA, management systems that would VerDate Sep<11>2014 17:42 Mar 13, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1

13634 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices incorporate and formalize knowledge DATES: The public workshop will be comment, as well as any attachments, shared with FDA by patient held on May 3, 2017, from 8:30 a.m. to except for information submitted, stakeholders and FDA’s relationships 4:30 p.m. The registration deadline to marked and identified, as confidential, with patient communities, and attend either in person, or virtually via if submitted as detailed in • developing a scalable and forward- web cast, is April 5, 2017. Comments ‘‘Instructions.’’ looking platform for communicating regarding this public workshop may be Instructions: All submissions received with patient stakeholders, particularly submitted March 2, 2017, through June must include the Docket No. FDA– online channels. 2, 2017. 2013–N–0402 for ‘‘Generic Drug User Under this proposal to enhance ADDRESSES: The public workshop will Fee Amendments of 2012; Regulatory mechanisms for patient engagement at be held at the FDA White Oak Campus, Science Initiatives; Public Workshop; FDA, a new ‘‘Office of Patient Affairs’’ 10903 New Hampshire Ave., Building Request for Comments.’’ Received would be directly accountable to the 31 Conference Center, the Great Room comments will be placed in the docket medical product Centers through clear (Rm. 1503, Section A), Silver Spring, and, except for those submitted as governance structures. In addition, a MD 20993–0002. Entrance for the public ‘‘Confidential Submissions,’’ publicly regular evaluation of this central office workshop participants (non-FDA viewable at https://www.regulations.gov and of FDA’s overall patient engagement employees) is through Building 1, where or at the Division of Dockets efforts is proposed. This evaluation will routine security check procedures will Management between 9 a.m. and 4 p.m., include feedback from external be performed. For parking and security Monday through Friday. stakeholders (including patients and information, please refer to http:// • Confidential Submissions—To their advocates) on a biennial basis to www.fda.gov/AboutFDA/ submit a comment with confidential best ensure the Agency’s ongoing WorkingatFDA/BuildingsandFacilities/ information that you do not wish to be responsiveness to the needs of patient WhiteOakCampusInformation/ made publicly available, submit your communities. ucm241740.htm. comments only as a written/paper Dated: March 9, 2017. You may submit comments as submission. You should submit two Leslie Kux, follows: copies total. One copy will include the Associate Commissioner for Policy. Electronic Submissions information you claim to be confidential [FR Doc. 2017–04982 Filed 3–13–17; 8:45 am] with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS BILLING CODE 4164–01–P following way: CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the the claimed confidential information, in HUMAN SERVICES instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the Food and Drug Administration including attachments, to https:// claimed confidential information www.regulations.gov will be posted to redacted/blacked out, will be available [Docket No. FDA–2013–N–0402] the docket unchanged. Because your for public viewing and posted on Generic Drug User Fee Amendments of comment will be made public, you are https://www.regulations.gov. Submit 2012; Regulatory Science Initiatives; solely responsible for ensuring that your both copies to the Division of Dockets Public Workshop; Request for comment does not include any Management. If you do not wish your Comments confidential information that you or a name and contact information to be third party may not wish to be posted, made publicly available, you can AGENCY: Food and Drug Administration, such as medical information, your or provide this information on the cover HHS. anyone else’s Social Security number, or sheet and not in the body of your ACTION: Notice of public workshop. confidential business information, such comments and you must identify this as a manufacturing process. Please note information as ‘‘confidential.’’ Any SUMMARY: The Food and Drug that if you include your name, contact Administration (FDA, the Agency, or information marked as ‘‘confidential’’ information, or other information that will not be disclosed except in we) is announcing the following public identifies you in the body of your workshop entitled ‘‘Generic Drug User accordance with 21 CFR 10.20 and other comments, that information will be applicable disclosure law. For more Fee Amendments of 2012; Regulatory posted on https://www.regulations.gov. Science Initiatives.’’ The topics to be information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR discussed will provide an overview of with confidential information that you the current status of regulatory science 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ initiatives for generic drugs and an public, submit the comment as a opportunity for public input on research regulatoryinformation/dockets/ written/paper submission and in the default.htm. priorities in this area. FDA is seeking manner detailed (see ‘‘Written/Paper this input from a variety of Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). read background documents or the stakeholders—industry, academia, patient advocates, professional societies, Written/Paper Submissions electronic and written/paper comments and other interested parties—as it Submit written/paper submissions as received, go to https:// fulfills its commitment under the www.regulations.gov and insert the asabaliauskas on DSK3SPTVN1PROD with NOTICES follows: Generic Drug User Fee Amendments of • Mail/Hand delivery/Courier (for docket number, found in brackets in the 2012 (GDUFA) to develop an annual list written/paper submissions): Division of heading of this document, into the of regulatory science initiatives specific Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts to generic drugs. FDA will take the and Drug Administration, 5630 Fishers and/or go to the Division of Dockets information it obtains from the public Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. workshop into account in developing • For written/paper comments 1061, Rockville, MD 20852. the fiscal year (FY) 2018 Regulatory submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Science Plan. Management, FDA will post your Stephanie Choi, Center for Drug VerDate Sep<11>2014 17:42 Mar 13, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1


Document Created: 2017-03-14 02:51:50
Document Modified: 2017-03-14 02:51:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments.
DatesSubmit either electronic or written comments by June 12, 2017.
ContactSharnell Ligon, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993, 301-796-5253, FAX: 301-847-3532.
FR Citation82 FR 13632 
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