[Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 1345-1347 [2016-32019]

Download as PDF Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ We 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.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. Submit written requests for single copies of the draft guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1450. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘Reference Amounts Customarily Consumed: List of Products for Each Product Category.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 thinking of the FDA on which products belong to product categories included in the tables of RACCs per Eating Occasion established in § 101.12(b) (21 CFR 101.12(b)). This draft guidance does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. We intend for this draft guidance, when finalized, to help industry comply with the statutory requirement, under section 403(q)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)), that food that is intended for human consumption and offered for sale bear nutrition information that provides a serving size that reflects the amount of food customarily consumed and is expressed in a common household measure that is appropriate to the food. To comply with this requirement, manufacturers must determine and label their food products with the appropriate label serving size based on the amount of the product customarily consumed. In the Federal Register of May 27, 2016, we issued a final rule entitled ‘‘Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments’’ (81 FR 34000). The final rule amends our regulations in § 101.12(b) to update or modify certain pre-existing RACCs, and to establish RACCs for new product categories. The draft guidance, when finalized, will help manufacturers identify the appropriate food category to which their product belongs, on which information manufacturers will be able to base the label serving size. The RACCs established in § 101.12(b) are divided into two tables: One for infants and young children 1 through 3 years of age, and another for the general food supply (i.e., individuals four years and older). The draft guidance, when finalized, will provide examples of products that belong to product categories for which a RACC has been established in § 101.12(b). The tables in the draft guidance are not meant to be an allinclusive list of products that are available on the market for each product category. II. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 1345 sentence to find the most current version of the guidance. Dated: December 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–32006 Filed 1–4–17; 8:45 am] BILLING CODE 4164–01–P 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. Notice of meeting; establishment of a public docket; request for comments. ACTION: 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. SUMMARY: 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 https:// doubletree3.hilton.com/en/hotels/ maryland/doubletree-by-hilton-hotelwashington-dc-silver-spring-DCASSDT/ about/amenities.html. You may submit comments as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the E:\FR\FM\05JAN1.SGM 05JAN1 1346 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES 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 VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 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.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: marieann.brill@fda.hhs.gov, 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 https:// 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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: https://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 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES 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 fdaoma@fda.hhs.gov 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 https://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 VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–4414] Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. Notification of availability with request for comments. ACTION: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ‘‘Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.’’ The draft guidance, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format for Nutrition and Supplement Facts labels. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 1347 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– 2016–D–4414 for ‘‘Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.’’ 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’’ E:\FR\FM\05JAN1.SGM 05JAN1

Agencies

[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1345-1347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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: https://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: 
marieann.brill@fda.hhs.gov, 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 https://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: https://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 fdaoma@fda.hhs.gov 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 https://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

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