82 FR 18148 - Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 72 (April 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 72 (April 17, 2017)
| Page Range | 18148-18150 | |
| FR Document | 2017-07667 |
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)] [Notices] [Pages 18148-18150] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07667] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1847] Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public. DATES: The meeting will be held on May 8, 2017, from 8:30 a.m. to 4:30 p.m. and May 9, 2017, from 8:30 a.m. to 12 noon. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-1847. The docket will close on May 5, 2017. Comments received on or before April 24, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions, including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 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-1847 for ``Pharmacy Compounding Advisory Committee; Notice of Meeting; 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. [[Page 18149]] 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: 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or licensed physician, to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice (CGMP)); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). The Drug Quality and Security Act added a new section 503B to the FD&C Act (21 U.S.C. 353b), which created a new category of compounders termed ``outsourcing facilities.'' Under section 503B of the FD&C Act, outsourcing facilities are defined, in part, as facilities that meet certain conditions described in section 503B, including registration with FDA as an outsourcing facility. If these conditions are satisfied, a drug product compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) Section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); (2) section 505 (concerning the approval of human drug products under NDAs or ANDAs); and (3) section 582 (21 U.S.C. 360eee-1) (concerning the drug supply chain security requirements). Outsourcing facilities are not exempt from CGMP requirements in section 501(a)(2)(B) of the FD&C Act. One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug product must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary (the ``503A Bulks List'') (see section 503A(b)(1)(A)(i) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the compounded drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product (see section 503A(b)(3)(A) of the FD&C Act). A condition that must be satisfied to qualify for the exemptions in section 503B of the FD&C Act is that the compounded drug is not identified (directly or as part of a category of drugs) on a list, published by the Secretary by regulation after consulting with the PCAC, of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients, or the drug is compounded in accordance with all applicable conditions identified on the list as conditions that are necessary to prevent the drug or category of drugs from presenting such demonstrable difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act). FDA intends to discuss with the committee bulk drug substances nominated for inclusion on the 503A Bulks List and drug products nominated for inclusion on the list of drug products that present demonstrable difficulties for compounding under sections 503A and 503B (``Difficult to Compound List''). Agenda: The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this [[Page 18150]] advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination. ------------------------------------------------------------------------ Drug Use(s) reviewed ------------------------------------------------------------------------ Nicotinamide adenine dinucleotide...... Reducing fatigue in multiple sclerosis. Nicotinamide adenine dinucleotide Reduce symptoms of fatigue in disodium reduced. chronic fatigue syndrome. Nettle (Urtica dioica) whole plant..... Glycemic control. Ubiquinol.............................. Glycemic control. Vanadyl sulfate........................ Diabetes, hypoglycemia, hyperlipidemia, heart disease, preventing cancer. Artemisinin............................ Malaria, protozoal infections (particularly toxoplasmosis), helminthic infections, stomach ulcers, cancer. ------------------------------------------------------------------------ The committee also intends to discuss oral solid modified release drug products that employ coated systems, which were nominated for the Difficult to Compound List. The nominators will be invited to make a short presentation supporting the nomination. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the Addresses section) on or before April 24, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 10:25 a.m., 11:35 a.m. and 11:45 a.m., 1:45 p.m. and 1:55 p.m., 2:50 p.m. and 3 p.m., and 4:10 p.m. and 4:20 p.m. on May 8, 2017, and between approximately 10 a.m. and 10:10 a.m. and 11:35 a.m. and 11:50 a.m. on May 9, 2017. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 14, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 17, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Cindy Hong at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-07667 Filed 4-14-17; 8:45 am] BILLING CODE 4164-01-P
![18148 Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
303–S; Section 73.3555(d), Daily references in the form to this be accessed at: http://www.fda.gov/
Newspaper Cross-Ownership. requirement. AdvisoryCommittees/
Form Number: FCC Form 303–S. We are making the following specific AboutAdvisoryCommittees/
Type of Review: Revision of a changes to FCC Form 303–S: ucm408555.htm. You may submit
currently approved collection. On page 5 of the form, we are comments as follows:
Respondents: Business or other for removing item 4 (Violent Programming).
profit entities; Not for profit institutions; On page 25 of the instructions, we are Electronic Submissions
State, Local or Tribal Governments. removing the paragraph titled ‘‘Item 4: Submit electronic comments in the
Number of Respondent and Violent Programming.’’ following way:
Responses: 4,023 respondents, 4,023 Federal Communications Commission. • Federal eRulemaking Portal:
responses. https://www.regulations.gov. Follow the
Katura Jackson,
Obligation to Respond: Required to instructions for submitting comments.
obtain benefits—Statutory authority for Federal Register Liaison Officer. Office of the
Secretary. Comments submitted electronically,
this collection of information is including attachments, to https://
contained in Sections 154(i), 303, 307 [FR Doc. 2017–07664 Filed 4–14–17; 8:45 am]
www.regulations.gov will be posted to
and 308 of the Communications Act of BILLING CODE 6712–01–P
the docket unchanged. Because your
1934, as amended, and Section 204 of comment will be made public, you are
the Telecommunications Act of 1996. solely responsible for ensuring that your
Estimated Time per Response: 1.25– DEPARTMENT OF HEALTH AND
comment does not include any
12 hours. HUMAN SERVICES
confidential information that you or a
Frequency of Response: Every eight
Food and Drug Administration third party may not wish to be posted,
year reporting requirement; Third party
such as medical information, your or
disclosure requirement. [Docket No. FDA–2017–N–1847] anyone else’s Social Security number, or
Total Annual Burden: 10,797 hours.
Total Annual Costs: $5,073,271. confidential business information, such
Pharmacy Compounding Advisory as a manufacturing process. Please note
Nature of Response: Required to Committee; Notice of Meeting;
obtain or retain benefits. The statutory that if you include your name, contact
Establishment of a Public Docket; information, or other information that
authority for the collection is contained Request for Comments
Sections 154(i), 303, 307 and 308 of the identifies you in the body of your
Communications Act of 1934, as AGENCY: Food and Drug Administration, comments, that information will be
amended, and Section 204 of the HHS. posted on https://www.regulations.gov.
Telecommunications Act of 1996. ACTION: Notice; establishment of a • If you want to submit a comment
Nature and Extent of Confidentiality: public docket; request for comments. with confidential information that you
There is no need for confidentiality with do not wish to be made available to the
this information collection. SUMMARY: The Food and Drug public, submit the comment as a
Privacy Act Impact Assessment: No Administration (FDA) announces a written/paper submission and in the
impact(s). forthcoming public advisory committee manner detailed (see ‘‘Written/Paper
Needs and Uses: FCC Form 303–S is meeting of the Pharmacy Compounding Submissions’’ and ‘‘Instructions’’).
used in applying for renewal of license Advisory Committee (PCAC). The
general function of the committee is to Written/Paper Submissions
for commercial or noncommercial AM,
FM, TV, FM translator, TV translator, provide advice on scientific, technical, Submit written/paper submissions as
Class A TV, or Low Power TV, and Low and medical issues concerning drug follows:
Power FM broadcast station licenses. compounding under the Federal Food, • Mail/Hand delivery/Courier (for
Licensees of broadcast stations must Drug, and Cosmetic Act (the FD&C Act), written/paper submissions): Division of
apply for renewal of their licenses every and, as required, any other product for Dockets Management (HFA–305), Food
eight years. The Commission is revising which FDA has regulatory and Drug Administration, 5630 Fishers
this collection to reflect the adoption of responsibility, and to make appropriate Lane, Rm. 1061, Rockville, MD 20852.
a Report and Order (‘‘R&O’’) in MB recommendations to the Agency. The • For written/paper comments
Docket No. 16–161, FCC 17–3, In the meeting will be open to the public. submitted to the Division of Dockets
Matter of Revisions to Public Inspection DATES: The meeting will be held on May Management, FDA will post your
File Requirements—Broadcaster 8, 2017, from 8:30 a.m. to 4:30 p.m. and comment, as well as any attachments,
Correspondence File and Cable May 9, 2017, from 8:30 a.m. to 12 noon. except for information submitted,
Principal Headend Location, adopted FDA is establishing a docket for marked and identified, as confidential,
and released on January 31, 2017. The public comment on this meeting. The if submitted as detailed in
R&O eliminated the requirement that docket number is FDA–2017–N–1847. ‘‘Instructions.’’
commercial TV stations retain in their The docket will close on May 5, 2017. Instructions: All submissions received
public inspection file copies of letters Comments received on or before April must include the Docket No. FDA–
and emails from the public. As the 24, 2017, will be provided to the 2017–N–1847 for ‘‘Pharmacy
Commission noted in the R&O, because committee. Comments received after Compounding Advisory Committee;
commercial TV licensees will no longer that date will be taken into Notice of Meeting; Establishment of a
be required to maintain correspondence consideration by the Agency. Public Docket; Request for Comments.’’
under our rules, under the terms of 47 ADDRESSES: FDA White Oak Campus, Received comments will be placed in
mstockstill on DSK30JT082PROD with NOTICES
U.S.C. Section 308(d) they also will not 10903 New Hampshire Ave., Bldg. 31 the docket and, except for those
be required to file a summary of Conference Center, the Great Room (Rm. submitted as ‘‘Confidential
correspondence received regarding 1503), Silver Spring, MD 20993–0002. Submissions,’’ publicly viewable at
violent programming with their renewal Answers to commonly asked questions, https://www.regulations.gov or at the
application (FCC Form 303–S). including information regarding special Division of Dockets Management
Consistent with this decision, we are accommodations due to a disability, between 9 a.m. and 4 p.m., Monday
revising Form 303–S to remove the visitor parking, and transportation may through Friday.
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![18150 Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
advisory committee meeting. The invited to make a short presentation
nominators of these substances will be supporting the nomination.
Drug Use(s) reviewed
Nicotinamide adenine dinucleotide .......................................... Reducing fatigue in multiple sclerosis.
Nicotinamide adenine dinucleotide disodium reduced ............. Reduce symptoms of fatigue in chronic fatigue syndrome.
Nettle (Urtica dioica) whole plant ............................................. Glycemic control.
Ubiquinol ................................................................................... Glycemic control.
Vanadyl sulfate ......................................................................... Diabetes, hypoglycemia, hyperlipidemia, heart disease, preventing cancer.
Artemisinin ................................................................................ Malaria, protozoal infections (particularly toxoplasmosis), helminthic infections,
stomach ulcers, cancer.
The committee also intends to discuss speakers for the scheduled open public the public; public comment sessions
oral solid modified release drug hearing session. The contact person will will be held during the meeting.
products that employ coated systems, notify interested persons regarding their DATES: The meeting will be held on June
which were nominated for the Difficult request to speak by April 17, 2017. 6 and 7, 2017. The meeting times and
to Compound List. The nominators will Persons attending FDA’s advisory agenda will be posted on the NVAC
be invited to make a short presentation committee meetings are advised that the Web site at http://www.hhs.gov/nvpo/
supporting the nomination. Agency is not responsible for providing nvac/meetings/index.html as soon as
FDA intends to make background access to electrical outlets. they become available.
material available to the public no later FDA welcomes the attendance of the ADDRESSES: U.S. Department of Health
than 2 business days before the meeting. public at its advisory committee and Human Services, Hubert H.
If FDA is unable to post the background meetings and will make every effort to Humphrey Building, Great Hall, 200
material on its Web site prior to the accommodate persons with disabilities. Independence Avenue SW.,
meeting, the background material will If you require accommodations due to a Washington, DC 20201.
be made publicly available at the disability, please contact Cindy Hong at Pre-registration is required for
location of the advisory committee least 7 days in advance of the meeting. members of the public who wish to
meeting, and the background material FDA is committed to the orderly attend the meeting and who wish to
will be posted on FDA’s Web site after conduct of its advisory committee participate in the public comment
the meeting. Background material is meetings. Please visit our Web site at session. Individuals who wish to attend
available at http://www.fda.gov/ http://www.fda.gov/ the meeting and/or participate in the
AdvisoryCommittees/Calendar/ AdvisoryCommittees/ public comment session should register
default.htm. Scroll down to the AboutAdvisoryCommittees/ at http://www.hhs.gov/nvpo/nvac/
appropriate advisory committee meeting ucm111462.htm for procedures on meetings/index.html. Participants may
link. public conduct during advisory also register by emailing nvpo@hhs.gov
Procedure: Interested persons may committee meetings. or by calling (202) 690–5566 and
present data, information, or views, Notice of this meeting is given under providing their name, organization and
orally or in writing, on issues pending the Federal Advisory Committee Act (5 email address.
before the committee. All electronic and U.S.C. app. 2). The meeting can also be accessed
written submissions submitted to the through a live webcast on both days of
Dated: April 11, 2017.
Docket (see the ADDRESSES section) on the meeting. For more information, visit
or before April 24, 2017, will be Anna K. Abram,
Deputy Commissioner for Policy, Planning, http://www.hhs.gov/nvpo/nvac/
provided to the committee. Oral meetings/index.html.
presentations from the public will be Legislation, and Analysis.
[FR Doc. 2017–07667 Filed 4–14–17; 8:45 am] FOR FURTHER INFORMATION CONTACT:
scheduled between approximately 10:15
a.m. and 10:25 a.m., 11:35 a.m. and BILLING CODE 4164–01–P National Vaccine Program Office, U.S.
11:45 a.m., 1:45 p.m. and 1:55 p.m., 2:50 Department of Health and Human
p.m. and 3 p.m., and 4:10 p.m. and 4:20 Services, Room 715H, Hubert H.
p.m. on May 8, 2017, and between DEPARTMENT OF HEALTH AND Humphrey Building, 200 Independence
approximately 10 a.m. and 10:10 a.m. HUMAN SERVICES Avenue SW., Washington, DC 20201.
and 11:35 a.m. and 11:50 a.m. on May Phone: (202) 690–5566; email: nvpo@
Meeting of the National Vaccine hhs.gov.
9, 2017. Those individuals interested in Advisory Committee
making formal oral presentations should SUPPLEMENTARY INFORMATION: Pursuant
notify the contact person and submit a AGENCY: Office of the Secretary, Office to Section 2101 of the Public Health
brief statement of the general nature of of the Assistant Secretary for Health, Service Act (42 U.S.C. 300aa–1), the
the evidence or arguments they wish to National Vaccine Program Office, Secretary of Health and Human Services
present, the names and addresses of Department of Health and Human was mandated to establish the National
proposed participants, and an Services. Vaccine Program to achieve optimal
indication of the approximate time ACTION: Notice. prevention of human infectious diseases
requested to make their presentation on through immunization and to achieve
mstockstill on DSK30JT082PROD with NOTICES
or before April 14, 2017. Time allotted SUMMARY: As stipulated by the Federal optimal prevention against adverse
for each presentation may be limited. If Advisory Committee Act, the reactions to vaccines. The NVAC was
the number of registrants requesting to Department of Health and Human established to provide advice and make
speak is greater than can be reasonably Services is hereby giving notice that a recommendations to the Director of the
accommodated during the scheduled meeting is scheduled to be held for the National Vaccine Program on matters
open public hearing session, FDA may National Vaccine Advisory Committee related to the Program’s responsibilities.
conduct a lottery to determine the (NVAC). The meeting will be open to The Assistant Secretary for Health
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Document Created: 2018-08-25 11:26:45
Document Modified: 2018-08-25 11:26:45
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on May 8, 2017, from 8:30 a.m. to 4:30 p.m. and May 9, 2017, from 8:30 a.m. to 12 noon. | |
| Contact | Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 18148 |
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