82 FR 1345 - [Pediatric 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 3 (January 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 3 (January 5, 2017)
| Page Range | 1345-1347 | |
| FR Document | 2016-32019 |
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)] [Notices] [Pages 1345-1347] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-32019] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0567] [Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comments. DATES: The meeting will be held on March 6, 2017, from 8:30 a.m. to 5:30 p.m. and March 7, 2017, from 8:30 a.m. to 12 p.m. The deadline for submitting comments to the public docket is February 17, 2017. Comments received on or before February 17, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. ADDRESSES: The meeting will be held at DoubleTree by Hilton Hotel Washington DC--Silver Spring, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel's telephone number is 301-589-5200. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-dc-silver-spring-DCASSDT/about/amenities.html. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the [[Page 1346]] 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 make 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 submission 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-2016-N-0567 for ``Pediatric 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. 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: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, 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. 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: Agenda: The PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). Comments about the upcoming March advisory committee meeting should be submitted to Docket No. FDA-2016-N-0567. On March 6, 2017, the PAC will meet to discuss the following products (listed by FDA Center): (1) Center for Drug Evaluation and Research (CDER) a. NITROPRESS (sodium nitroprusside) b. KUVAN (sapropterin dihydrochloride) c. TRUVADA (emtricitabine/tenofovir disoproxil fumarate) FDA will provide the analysis of a possible safety signal regarding the use of the drug product EXJADE (deferasirox) in children with fever and dehydration, which was discussed at the September 2015 PAC meeting. The PAC will also discuss the role of pharmacogenomics in pediatric product development. On March 7, 2017, the PAC will meet to discuss the following products (listed by FDA Center): (2) Center for Biologics Evaluation and Research (CBER) a. EPICEL (cultured epidermal autografts) (humanitarian device exemption (HDE)) b. NOVOEIGHT (Antihemophilic Factor (Recombinant)) c. RIXUBIS Coagulation Factor IX (Recombinant) (3) Center for Devices and Radiological Health (CDRH) a. IMPELLA RP SYSTEM (HDE) b. LIPOSORBER LA-15 SYSTEM (HDE) c. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE) 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 will be 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. Written submissions may be made to the contact person on or before February 27, 2017. Oral presentations from the public will be scheduled on March 6 and 7, 2017, between approximately 9 a.m. and 9:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a [[Page 1347]] 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 February 17, 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 February 21, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this document. The docket number is FDA-2016-N-0567. The docket will close on February 17, 2017. Comments received on or before February 17, 2017 will be provided to the committee. Comments received after the date will be taken into consideration by the Agency. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796- 4540. 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 Marieann Brill 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: December 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-32019 Filed 1-4-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1345
with a heading or cover note that states thinking of the FDA on which products sentence to find the most current
‘‘THIS DOCUMENT CONTAINS belong to product categories included in version of the guidance.
CONFIDENTIAL INFORMATION.’’ We the tables of RACCs per Eating Occasion Dated: December 30, 2016.
will review this copy, including the established in § 101.12(b) (21 CFR Leslie Kux,
claimed confidential information, in its 101.12(b)). This draft guidance does not
Associate Commissioner for Policy.
consideration of comments. The second establish any rights for any person and
is not binding on FDA or the public. [FR Doc. 2016–32006 Filed 1–4–17; 8:45 am]
copy, which will have the claimed
confidential information redacted/ You can use an alternate approach if it BILLING CODE 4164–01–P
blacked out, will be available for public satisfies the requirements of the
viewing and posted on https:// applicable statutes and regulations.
We intend for this draft guidance, DEPARTMENT OF HEALTH AND
www.regulations.gov. Submit both
when finalized, to help industry comply HUMAN SERVICES
copies to the Division of Dockets
Management. If you do not wish your with the statutory requirement, under
Food and Drug Administration
name and contact information to be section 403(q)(1)(A)(i) of the Federal
made publicly available, you can Food, Drug, and Cosmetic Act (the [Docket No. FDA–2016–N–0567]
provide this information on the cover FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)),
sheet and not in the body of your that food that is intended for human [Pediatric Advisory Committee; Notice
comments and you must identify this consumption and offered for sale bear of Meeting; Establishment of a Public
information as ‘‘confidential.’’ Any nutrition information that provides a Docket; Request for Comments
information marked as ‘‘confidential’’ serving size that reflects the amount of AGENCY: Food and Drug Administration,
will not be disclosed except in food customarily consumed and is HHS.
accordance with 21 CFR 10.20 and other expressed in a common household
measure that is appropriate to the food. ACTION: Notice of meeting;
applicable disclosure law. For more establishment of a public docket;
information about FDA’s posting of To comply with this requirement,
manufacturers must determine and label request for comments.
comments to public dockets, see 80 FR
56469, September 18, 2015, or access their food products with the appropriate SUMMARY: The Food and Drug
the information at: http://www.fda.gov/ label serving size based on the amount Administration (FDA) announces a
regulatoryinformation/dockets/ of the product customarily consumed. forthcoming public advisory committee
default.htm. In the Federal Register of May 27, meeting of the Pediatric Advisory
Docket: For access to the docket to 2016, we issued a final rule entitled Committee (PAC). The general function
read background documents or the ‘‘Food Labeling: Serving Sizes of Foods of the committee is to provide advice
electronic and written/paper comments That Can Reasonably Be Consumed At and recommendations to the Agency on
received, go to https:// One Eating Occasion; Dual-Column FDA’s regulatory issues. The meeting
www.regulations.gov and insert the Labeling; Updating, Modifying, and will be open to the public. FDA is
Establishing Certain Reference Amounts establishing a docket for public
docket number, found in brackets in the
Customarily Consumed; Serving Size for comments.
heading of this document, into the
Breath Mints; and Technical
‘‘Search’’ box and follow the prompts DATES: The meeting will be held on
Amendments’’ (81 FR 34000). The final
and/or go to the Division of Dockets March 6, 2017, from 8:30 a.m. to 5:30
rule amends our regulations in
Management, 5630 Fishers Lane, Rm. p.m. and March 7, 2017, from 8:30 a.m.
§ 101.12(b) to update or modify certain
1061, Rockville, MD 20852. to 12 p.m. The deadline for submitting
pre-existing RACCs, and to establish
Submit written requests for single comments to the public docket is
RACCs for new product categories.
copies of the draft guidance to the Office The draft guidance, when finalized, February 17, 2017. Comments received
of Nutrition and Food Labeling, Center will help manufacturers identify the on or before February 17, 2017, will be
for Food Safety and Applied Nutrition, appropriate food category to which their provided to the committee. Comments
Food and Drug Administration, 5001 product belongs, on which information received after that date will be taken
Campus Dr., College Park, MD 20740. manufacturers will be able to base the into consideration by the Agency.
Send two self-addressed adhesive labels label serving size. The RACCs ADDRESSES: The meeting will be held at
to assist that office in processing your established in § 101.12(b) are divided DoubleTree by Hilton Hotel Washington
request. See the SUPPLEMENTARY into two tables: One for infants and DC—Silver Spring, 8727 Colesville Rd.,
INFORMATION section for electronic
young children 1 through 3 years of age, Silver Spring, MD 20910. The hotel’s
access to the draft guidance. and another for the general food supply telephone number is 301–589–5200.
FOR FURTHER INFORMATION CONTACT: (i.e., individuals four years and older). Answers to commonly asked questions
Jillonne Kevala, Center for Food Safety The draft guidance, when finalized, will including information regarding special
and Applied Nutrition, Food and Drug provide examples of products that accommodations due to a disability,
Administration, 5001 Campus Dr., belong to product categories for which visitor parking, and transportation may
College Park, MD 20740, 240–402–1450. a RACC has been established in be accessed at http://
SUPPLEMENTARY INFORMATION: § 101.12(b). The tables in the draft doubletree3.hilton.com/en/hotels/
I. Background guidance are not meant to be an all- maryland/doubletree-by-hilton-hotel-
inclusive list of products that are washington-dc-silver-spring-DCASSDT/
We are announcing the availability of available on the market for each product about/amenities.html.
a draft guidance for industry entitled
mstockstill on DSK3G9T082PROD with NOTICES
category. You may submit comments as
‘‘Reference Amounts Customarily follows:
Consumed: List of Products for Each II. Electronic Access
Product Category.’’ We are issuing the Persons with access to the Internet Electronic Submissions
draft guidance consistent with our good may obtain the draft guidance at either Submit electronic comments in the
guidance practices regulation (21 CFR http://www.fda.gov/FoodGuidances or following way:
10.115). The draft guidance, when https://www.regulations.gov. Use the • Federal eRulemaking Portal:
finalized, will represent the current FDA Web site listed in the previous https://www.regulations.gov. Follow the
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![Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1347
brief statement of the general nature of DEPARTMENT OF HEALTH AND comments, that information will be
the evidence or arguments they wish to HUMAN SERVICES posted on https://www.regulations.gov.
present, the names and addresses of • If you want to submit a comment
proposed participants, and an Food and Drug Administration with confidential information that you
indication of the approximate time do not wish to be made available to the
[Docket No. FDA–2016–D–4414] public, submit the comment as a
requested to make their presentation on
or before February 17, 2017. Time written/paper submission and in the
Questions and Answers on the
allotted for each presentation may be manner detailed (see ‘‘Written/Paper
Nutrition and Supplement Facts Labels
Submissions’’ and ‘‘Instructions’’).
limited. If the number of registrants Related to the Compliance Date, Added
requesting to speak is greater than can Sugars, and Declaration of Written/Paper Submissions
be reasonably accommodated during the Quantitative Amounts of Vitamins and Submit written/paper submissions as
scheduled open public hearing session, Minerals; Draft Guidance for Industry; follows:
FDA may conduct a lottery to determine Availability • Mail/Hand delivery/Courier (for
the speakers for the scheduled open AGENCY: Food and Drug Administration, written/paper submissions): Division of
public hearing session. The contact HHS. Dockets Management (HFA–305), Food
person will notify interested persons and Drug Administration, 5630 Fishers
ACTION: Notification of availability with Lane, Rm. 1061, Rockville, MD 20852.
regarding their request to speak by
request for comments. • For written/paper comments
February 21, 2017.
submitted to the Division of Dockets
Persons attending FDA’s advisory SUMMARY: The Food and Drug
Management, FDA will post your
committee meetings are advised that the Administration (FDA or we) is
comment, as well as any attachments,
Agency is not responsible for providing announcing the availability of a draft
except for information submitted,
access to electrical outlets. guidance for industry entitled
marked and identified, as confidential,
‘‘Questions and Answers on the
FDA is establishing a docket for if submitted as detailed in
Nutrition and Supplement Facts Labels
public comment on this document. The ‘‘Instructions.’’
Related to the Compliance Date, Added Instructions: All submissions received
docket number is FDA–2016–N–0567. Sugars, and Declaration of Quantitative
The docket will close on February 17, must include the Docket No. FDA–
Amounts of Vitamins and Minerals.’’ 2016–D–4414 for ‘‘Questions and
2017. Comments received on or before The draft guidance, when finalized, will
February 17, 2017 will be provided to Answers on the Nutrition and
provide questions and answers on Supplement Facts Labels Related to the
the committee. Comments received after topics related to compliance, labeling of Compliance Date, Added Sugars, and
the date will be taken into consideration added sugars, declaration of quantitative Declaration of Quantitative Amounts of
by the Agency. For press inquiries, amounts of vitamins and minerals, and Vitamins and Minerals.’’ Received
please contact the Office of Media format for Nutrition and Supplement comments will be placed in the docket
Affairs at fdaoma@fda.hhs.gov or 301– Facts labels. and, except for those submitted as
796–4540. DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly
FDA welcomes the attendance of the any guidance at any time (see 21 CFR viewable at https://www.regulations.gov
public at its advisory committee 10.115(g)(5)), to ensure that we consider or at the Division of Dockets
meetings and will make every effort to your comment on the draft guidance Management between 9 a.m. and 4 p.m.,
accommodate persons with disabilities. before we begin work on the final Monday through Friday.
If you require accommodations due to a version of the guidance, submit either • Confidential Submissions—To
disability, please contact Marieann Brill electronic or written comments on the submit a comment with confidential
at least 7 days in advance of the draft guidance by March 6, 2017. information that you do not wish to be
meeting. ADDRESSES: You may submit comments made publicly available, submit your
as follows: comments only as a written/paper
FDA is committed to the orderly submission. You should submit two
conduct of its advisory committee Electronic Submissions copies total. One copy will include the
meetings. Please visit our Web site at Submit electronic comments in the information you claim to be confidential
http://www.fda.gov/ following way: with a heading or cover note that states
AdvisoryCommittees/ • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
AboutAdvisoryCommittees/ https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
ucm111462.htm for procedures on instructions for submitting comments. Agency will review this copy, including
public conduct during advisory Comments submitted electronically, the claimed confidential information, in
committee meetings. including attachments, to https:// its consideration of comments. The
Notice of this meeting is given under www.regulations.gov will be posted to second copy, which will have the
the Federal Advisory Committee Act (5 the docket unchanged. Because your claimed confidential information
U.S.C. app. 2). comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
Dated: December 30, 2016. comment does not include any https://www.regulations.gov. Submit
Leslie Kux, confidential information that you or a both copies to the Division of Dockets
third party may not wish to be posted, Management. If you do not wish your
mstockstill on DSK3G9T082PROD with NOTICES
Associate Commissioner for Policy.
[FR Doc. 2016–32019 Filed 1–4–17; 8:45 am] such as medical information, your or name and contact information to be
BILLING CODE 4164–01–P
anyone else’s Social Security number, or made publicly available, you can
confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
that if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1](https://thefederalregister.org/doc/82_FR_1348/page/3.svg)
Document Created: 2018-02-01 14:51:11
Document Modified: 2018-02-01 14:51:11
| 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 meeting; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on March 6, 2017, from 8:30 a.m. to 5:30 p.m. and March 7, 2017, from 8:30 a.m. to 12 p.m. The deadline for submitting comments to the public docket is February 17, 2017. Comments received on or before February 17, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. | |
| Contact | Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, 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. 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 1345 |
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