82 FR 28665 - Patient-Focused Drug Development for Alopecia Areata; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 120 (June 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 120 (June 23, 2017)
| Page Range | 28665-28667 | |
| FR Document | 2017-13194 |
[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)] [Notices] [Pages 28665-28667] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13194] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3067] Patient-Focused Drug Development for Alopecia Areata; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on ``Patient-Focused Drug Development for Alopecia Areata.'' Patient- Focused Drug Development is part of FDA's performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of alopecia areata, including on daily life. FDA is also seeking patients' views on treatment approaches and decision factors taken into account when selecting a treatment. DATES: The public meeting will be held on September 11, 2017, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public meeting by November 13, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For more information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 13, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-2017-N-3067 for ``Patient-Focused Drug Development for Alopecia Areata.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 [[Page 28666]] 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. FDA will post the agenda approximately 5 days before the meeting at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm. FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, FAX: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Background on Patient-Focused Drug Development FDA has selected alopecia areata as the focus of a public meeting under the Patient-Focused Drug Development initiative. This initiative involves obtaining a better understanding of patients' perspectives on the severity of a disease and the available therapies for that condition. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments that are part of the PDUFA reauthorization under Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of performance commitments is available on the FDA Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. FDA committed to obtain the patient perspective on at least 20 disease areas during the course of PDUFA V. For each disease area, the Agency is conducting a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefits that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders. On April 11, 2013, FDA published a notice in the Federal Register (78 FR 21613), announcing the disease areas for meetings in fiscal years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V timeframe. The Agency used several criteria outlined in that notice to develop the list of disease areas. FDA obtained public comment on the Agency's proposed criteria and potential disease areas through a public docket and a public meeting that was convened on October 25, 2012. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. FDA initiated a second public process for determining the disease areas for FY 2016-2017, and published a notice in the Federal Register on July 2, 2015 (80 FR 38216), announcing the selection of eight disease areas. More information, including the list of disease areas and a general schedule of meetings, is posted at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm. II. Purpose and Scope of the Meeting As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on the symptoms of alopecia areata that matter most to patients and on current approaches to treating alopecia areata. Alopecia areata is an autoimmune disease that causes hair loss. The hair loss usually occurs on the scalp but can also affect the beard, eyebrows, and other areas of the body. While there is currently no cure, there are available treatments, such as corticosteroids or non-drug therapies, which may help hair regrowth. FDA is interested in the perspectives of patients with alopecia areata on: (1) The impact of their condition, (2) treatment approaches, and (3) decision factors taken into account when selecting a treatment. The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section and organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through electronic or written comments, which can be submitted to the Dockets Management Staff (see ADDRESSES). Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients 1. Of all the symptoms or disease manifestations that you experience because of your condition, which one to three symptoms or manifestations have the most significant impact on your life? Examples may include location or type of hair loss (i.e. loss of hair on scalp, loss of eyebrows, loss of all hair on body patchy hair loss), nail changes, hair quality upon regrowth. 2. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? Examples of activities may include daily hygiene, engagement in personal relationships, participation in sports or social activities, completion of school or work activities, etc. 3. How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days? 4. How has your condition changed over time? Would you define your condition today as being well- managed? 5. What worries you most about your condition? Topic 2: Patients' Perspectives on Current Approaches to Treatment 1. What are you currently doing to help treat your condition or its symptoms? Examples may include prescription medicines, over-the-counter products, and non-drug therapies such as diet modification. How has your treatment regimen changed over time, and why? 2. How well does your current treatment regimen control your condition? How well have these treatments worked for you as your condition has changed over time? 3. What are the most significant downsides to your current treatments, [[Page 28667]] and how do they affect your daily life? Examples of downsides may include going to the clinic for treatment, time devoted to treatment, side effects of treatment, route of administration, etc. 4. What specific things would you look for in an ideal treatment for your condition? What would you consider to be a meaningful improvement in your condition that a treatment could provide? 5. What factors do you take into account when making decisions about selecting a course of treatment? III. Meeting Attendance and Participation If you wish to attend this meeting, visit https://alopeciaareata.eventbrite.com. Persons interested in attending this public meeting must register by August 28, 2017. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations due to a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) no later than September 1, 2017. Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to [email protected] a brief summary of responses to the topic questions by August 21, 2017. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm. Dated: June 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13194 Filed 6-22-17; 8:45 am] BILLING CODE 4164-01-P
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Submit written requests for single DEPARTMENT OF HEALTH AND Electronic Submissions
copies of the Engineering Research HUMAN SERVICES Submit electronic comments in the
Center for Structured Organic following way:
Particulate Systems (C-SOPS) document Food and Drug Administration
• Federal eRulemaking Portal:
to the Division of Drug Information, [Docket No. FDA–2017–N–3067] https://www.regulations.gov. Follow the
Center for Drug Evaluation and instructions for submitting comments.
Research, Food and Drug Patient-Focused Drug Development for Comments submitted electronically,
Administration, 10903 New Hampshire Alopecia Areata; Public Meeting; including attachments, to https://
Ave., Bldg. 51, Rm. 2201, Silver Spring, Request for Comments www.regulations.gov will be posted to
MD 20993–0002. Send one self- the docket unchanged. Because your
addressed adhesive label to assist that AGENCY: Food and Drug Administration,
HHS. comment will be made public, you are
office in processing your requests. See solely responsible for ensuring that your
the SUPPLEMENTARY INFORMATION section ACTION: Notice of public meeting;
request for comments. comment does not include any
for electronic access to the C-SOPS confidential information that you or a
document. SUMMARY: The Food and Drug third party may not wish to be posted,
FOR FURTHER INFORMATION CONTACT: Sau Administration (FDA, the Agency, or such as medical information, your or
(Larry) Lee, Center for Drug Evaluation we) is announcing a public meeting and anyone else’s Social Security number, or
and Research, Food and Drug an opportunity for public comment on confidential business information, such
Administration, 10903 New Hampshire ‘‘Patient-Focused Drug Development for as a manufacturing process. Please note
Ave., Bldg. 22, Rm. 2128, Silver Spring, Alopecia Areata.’’ Patient-Focused Drug that if you include your name, contact
MD 20993–0002, 301–796–2905, Development is part of FDA’s information, or other information that
Sau.Lee@fda.hhs.gov. performance commitments under the identifies you in the body of your
fifth authorization of the Prescription comments, that information will be
SUPPLEMENTARY INFORMATION: Drug User Fee Act (PDUFA V). The posted on https://www.regulations.gov.
I. Background
public meeting is intended to allow • If you want to submit a comment
FDA to obtain patients’ perspectives on with confidential information that you
During a May 7, 2015, workshop on the impact of alopecia areata, including do not wish to be made available to the
the Future of Pharmaceutical on daily life. FDA is also seeking public, submit the comment as a
Manufacturing, FDA agreed that patients’ views on treatment approaches written/paper submission and in the
interested parties could submit for and decision factors taken into account manner detailed (see ‘‘Written/Paper
Agency consideration draft guidance or when selecting a treatment. Submissions’’ and ‘‘Instructions’’).
other materials discussing the science, DATES: The public meeting will be held
on September 11, 2017, from 1 p.m. to Written/Paper Submissions
technology, and best practices related to
continuous manufacturing. On June 13, 5 p.m. Submit either electronic or Submit written/paper submissions as
2016, C-SOPS submitted to FDA an written comments on this public follows:
industry-coordinated best practices meeting by November 13, 2017. See the • Mail/Hand delivery/Courier (for
document on continuous SUPPLEMENTARY INFORMATION section for written/paper submissions): Dockets
manufacturing. FDA is interested in registration date and information. Management Staff (HFA–305), Food and
public comments about the science, ADDRESSES: The public meeting will be Drug Administration, 5630 Fishers
technology, and practices discussed in held at the FDA White Oak Campus, Lane, Rm. 1061, Rockville, MD 20852.
the C-SOPS document and is opening 10903 New Hampshire Ave., Bldg. 31 • For written/paper comments
this docket for that purpose. In addition, Conference Center, the Great Room (Rm. submitted to the Dockets Management
FDA is seeking comments on other 1503), Silver Spring, MD 20993–0002. Staff, FDA will post your comment, as
recommendations regarding continuous Entrance for the public meeting well as any attachments, except for
manufacturing that have already been participants (non-FDA employees) is information submitted, marked and
published, including ‘‘Regulatory and through Building 1 where routine identified, as confidential, if submitted
Quality Considerations for Continuous security check procedures will be as detailed in ‘‘Instructions.’’
Manufacturing: May 20–21, 2014, performed. For more information on Instructions: All submissions received
Continuous Manufacturing parking and security procedures, please must include the Docket No. FDA–
Symposium.’’ FDA invites comment on refer to http://www.fda.gov/AboutFDA/ 2017–N–3067 for ‘‘Patient-Focused Drug
control strategy, facility, and process WorkingatFDA/BuildingsandFacilities/ Development for Alopecia Areata.’’
validation considerations for continuous WhiteOakCampusInformation/ Received comments, those filed in a
manufacturing of solid oral dosage ucm241740.htm. timely manner (see ADDRESSES), will be
forms. This request is not limited to You may submit comments as placed in the docket and, except for
comments on the proposal described in follows. Please note that late, untimely those submitted as ‘‘Confidential
the C-SOPS submission. filed comments will not be considered. Submissions,’’ publicly viewable at
Electronic comments must be submitted https://www.regulations.gov or at the
II. Electronic Access on or before November 13, 2017. The Dockets Management Staff between 9
Persons with access to the Internet https://www.regulations.gov electronic a.m. and 4 p.m., Monday through
asabaliauskas on DSKBBXCHB2PROD with NOTICES
may obtain the C-SOPS document at filing system will accept comments Friday.
https://www.regulations.gov. until midnight Eastern Time at the end • Confidential Submissions—To
of November 13, 2017. Comments submit a comment with confidential
Dated: June 15, 2017. received by mail/hand delivery/courier information that you do not wish to be
Anna K. Abram, (for written/paper submissions) will be made publicly available, submit your
Deputy Commissioner for Policy, Planning, considered timely if they are comments only as a written/paper
Legislation, and Analysis. postmarked or the delivery service submission. You should submit two
[FR Doc. 2017–13195 Filed 6–22–17; 8:45 am] acceptance receipt is on or before that copies total. One copy will include the
BILLING CODE 4164–01–P date. information you claim to be confidential
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and how do they affect your daily life? UserFees/PrescriptionDrugUserFee/ Program Deeming Applications for Free
Examples of downsides may include ucm554443.htm. Clinics, OMB No. 0915–0293—
going to the clinic for treatment, time Dated: June 20, 2017. Extension.
devoted to treatment, side effects of Anna K. Abram, Abstract: Section 224(o) of the Public
treatment, route of administration, etc. Health Service (PHS) Act (42 U.S.C.
Deputy Commissioner for Policy, Planning,
4. What specific things would you Legislation, and Analysis. 233(o)), as amended, authorizes the
look for in an ideal treatment for your [FR Doc. 2017–13194 Filed 6–22–17; 8:45 am] ‘‘deeming’’ of certain individuals as
condition? BILLING CODE 4164–01–P PHS employees for the purposes of
• What would you consider to be a receiving Federal Tort Claims Act
meaningful improvement in your (FTCA) coverage. Section 224(o) relates
condition that a treatment could DEPARTMENT OF HEALTH AND to employees, officers, and contractors
provide? HUMAN SERVICES at qualifying free clinics. The Free
5. What factors do you take into Clinics FTCA Program is administered
account when making decisions about Health Resources and Services by HRSA’s Bureau of Primary Health
selecting a course of treatment? Administration Care (BPHC). Sponsoring free clinics are
Agency Information Collection required by law to submit deeming
III. Meeting Attendance and
Activities: Proposed Collection: Public applications in the specified form and
Participation
Comment Request Information manner on behalf of named individuals
If you wish to attend this meeting, Collection Request Title: Federal Tort for review and approval, resulting in a
visit https:// Claims Act (FTCA) Program Deeming ‘‘deeming determination’’ that includes
alopeciaareata.eventbrite.com. Persons Applications for Free Clinics, OMB No. associated FTCA coverage for these
interested in attending this public 0915–0293—Extension individuals.
meeting must register by August 28, Need and Proposed Use of the
2017. If you are unable to attend the AGENCY: Health Resources and Services
Administration (HRSA), Department of Information: Deeming applications must
meeting in person, you can register to address certain specified criteria
view a live Webcast of the meeting. You Health and Human Services.
required by law for deeming
will be asked to indicate in your ACTION: Notice.
determinations to be issued, and FTCA
registration if you plan to attend in application forms are critical to BPHC’s
person or via the Webcast. Early SUMMARY: In compliance with the
requirement for opportunity for public deeming determination process. These
registration is recommended because forms provide BPHC with the
seating is limited; therefore, FDA may comment on proposed data collection
projects of the Paperwork Reduction Act information necessary to evaluate an
limit the number of participants from
of 1995, the Health Resources and application and determine whether an
each organization. Registrants will
Services Administration (HRSA) individual meets the requirements for
receive confirmation once they have
announces plans to submit an deemed PHS employee status for the
been accepted. Onsite registration on
Information Collection Request (ICR), purposes of FTCA coverage. FTCA
the day of the meeting will be based on
described below, to the Office of application forms for free clinics do not
space availability. If you need special
Management and Budget (OMB). Prior require any changes with this extension
accommodations due to a disability,
to submitting the ICR to OMB, HRSA other than to update the applicable
please contact Meghana Chalasani (see
seeks comments from the public dates.
FOR FURTHER INFORMATION CONTACT) no
later than September 1, 2017. regarding the burden estimate, below, or Likely Respondents: Respondents
any other aspect of the ICR. include free clinics seeking deemed
Patients who are interested in
presenting comments as part of the DATES: Comments on this Information PHS employee status on behalf of their
initial panel discussions will be asked Collection Request must be received no sponsored individuals for purposes of
to indicate in their registration which later than August 22, 2017. FTCA coverage.
topic(s) they wish to address. These ADDRESSES: Submit your comments to Burden Statement: Burden in this
patients also must send to paperwork@hrsa.gov or mail the HRSA context means the time expended by
PatientFocused@fda.hhs.gov a brief Information Collection Clearance persons to generate, maintain, retain,
summary of responses to the topic Officer, Room 14N39, 5600 Fishers disclose, or provide the information
questions by August 21, 2017. Panelists Lane, Rockville, MD 20857. requested. This includes the time
will be notified of their selection FOR FURTHER INFORMATION CONTACT: To needed to review instructions; to
approximately 7 days before the public request more information on the develop, acquire, install, and utilize
meeting. We will try to accommodate all proposed project or to obtain a copy of technology and systems for the purpose
patients and patient stakeholders who the data collection plans and draft of collecting, validating and verifying
wish to speak, either through the panel instruments, email paperwork@hrsa.gov information, processing and
discussion or audience participation; or call the HRSA Information Collection maintaining information, and disclosing
however, the duration of comments may Clearance Officer at (301) 443–1984. and providing information; to train
be limited by time constraints. SUPPLEMENTARY INFORMATION: When personnel and to be able to respond to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Transcripts: Please be advised that as submitting comments or requesting a collection of information; to search
soon as a transcript of the public information, please include the data sources; to complete and review
meeting is available, it will be accessible information request collection title for the collection of information; and to
at https://www.regulations.gov. It may reference, in compliance with Section transmit or otherwise disclose the
be viewed at the Dockets Management 3506(c)(2)(A) of the Paperwork information. The total annual burden
Staff (see ADDRESSES). A link to the Reduction Act of 1995. hours estimated for this Information
transcript will also be available at Information Collection Request Title: Collection Request are summarized in
https://www.fda.gov/ForIndustry/ Federal Tort Claims Act (FTCA) the table below.
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Document Created: 2017-06-23 03:37:46
Document Modified: 2017-06-23 03:37:46
| 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 public meeting; request for comments. | |
| Dates | The public meeting will be held on September 11, 2017, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public meeting by November 13, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, FAX: 301-847-8443, [email protected] | |
| FR Citation | 82 FR 28665 |
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