80 FR 70822 - Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of Applications; Final Resolution of Hearing Requests Regarding Transdermal Systems Under Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 220 (November 16, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 220 (November 16, 2015)
| Page Range | 70822-70825 | |
| FR Document | 2015-28853 |
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)] [Notices] [Pages 70822-70825] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28853] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1977-N-0356 (Formerly 77N-0240); DESI 1786] Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of Applications; Final Resolution of Hearing Requests Regarding Transdermal Systems Under Docket ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests regarding nitroglycerin drug [[Page 70823]] products in transdermal systems under Docket No. FDA-1977-N-0356 (formerly 77N-0240) (DESI 1786) have been withdrawn. Therefore, shipment in interstate commerce of any nitroglycerin drug product in a transdermal system identified in this docket, or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the effective date of this notice. DATES: Effective Date: This notice is effective November 16, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-1977-N-0356 for ``Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of Applications; Final Resolution of Hearing Requests Regarding Transdermal Systems Under Docket.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 http://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: Barbara Wise, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5160, Silver Spring, MD 20993-0002, 301- 796-2089, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background When enacted in 1938, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) required that ``new drugs'' (21 U.S.C. 321(p)) be approved for safety by FDA before they could legally be sold in interstate commerce. Between 1938 and 1962, if a drug obtained approval, FDA considered drugs that were IRS (see 21 CFR 310.6(b)(1)) to the approved drug to be covered by that approval, and allowed those IRS drugs to be marketed without independent approval. In 1962, Congress amended the FD&C Act to require that new drugs be proven effective for their labeled indications, as well as safe, in order to obtain FDA approval. This amendment also required FDA to conduct a retrospective evaluation of the effectiveness of the drug products that FDA had approved as safe between 1938 and 1962. FDA contracted with the National Academy of Science/National Research Council (NAS/NRC) to make an initial evaluation of the effectiveness of over 3,400 products that had been approved only for safety between 1938 and 1962. The NAS/NRC reports for these drug products were submitted to FDA in the late 1960s and early 1970s. The Agency reviewed and reevaluated the reports and published its findings in Federal Register notices. FDA's administrative implementation of the NAS/NRC reports was called the Drug Efficacy Study Implementation (DESI). DESI covered the approximately 3,400 products specifically reviewed by the NAS/NRC, as well as the even larger number of IRS products that entered the market without FDA approval. All drugs reviewed under DESI are ``new drugs'' under the FD&C Act. If FDA's final DESI determination classifies a drug product as lacking substantial evidence of effectiveness for one or more indications, that drug product and those IRS to it may no longer be marketed for such indications and are subject to enforcement action as unapproved new drugs. If FDA's final DESI determination classifies the drug product as effective for one or more of its labeled indications, the drug can be marketed for such indications, provided it is the subject of an application approved for safety and effectiveness. Sponsors of drug products that have been found to be effective for one or more indications through the DESI process may rely on FDA's effectiveness [[Page 70824]] determinations, but typically must update their labeling to conform to the indication(s) found to be effective by FDA and include any additional safety information required by FDA. Those drug products with NDAs approved before 1962 for safety therefore require approved supplements to their original applications if one or more indications are found to be effective under DESI; IRS drug products require an approved NDA or ANDA, as appropriate. Furthermore, labeling for drug products classified as effective may contain only those indications for which the review found the product effective unless the firm marketing the product has received an approval for the additional indication(s). II. Final Resolution of Hearing Requests Regarding Nitroglycerin Transdermal Systems Under Docket No. FDA-1977-N-0356 (formerly 77N- 0240); DESI 1786 In a Federal Register notice published in February 1972, FDA announced its evaluation of reports received from NAS/NRC regarding certain single-entity coronary vasodilators, including controlled- release nitroglycerin tablets, for indications relating to the management, prophylaxis, and treatment of angina attacks (37 FR 4001, February 25, 1972). In a Federal Register notice published in December 1972, FDA temporarily exempted specified single-entity coronary vasodilators covered by DESI from the time limits established for completing DESI (37 FR 26623 at 26624, December 14, 1972). The December 1972 notice did not initially include controlled-release forms of the drugs, but a notice published in July 1973 allowed the case-by-case addition of controlled-release dosage forms, pending the completion of scientific studies that showed a drug was released in a defined manner which would permit well-controlled clinical trials to determine effectiveness (38 FR 18477, 18478, July 11, 1973; corrected by 38 FR 19920, July 25, 1973). The December 1972 notice was amended again in August 1977, to announce the addition of controlled-release forms of specified coronary vasodilators, and the availability of guidelines and methods for determining the bioavailability of coronary vasodilators (42 FR 43127, August 26, 1977). The August 1977 notice specifically added nitroglycerin (topical ointment forms, conventional oral forms, and controlled release forms) to the list of drugs allowed to remain on the market while efficacy studies were conducted (42 FR 43127 at 43128). The December 1972 notice was further amended in October 1977, to extend the deadlines for submission of data and applications required for the coronary vasodilator products, and to announce the availability of guidelines for alternative methods of determining bioavailability for these products (42 FR 56156, October 21, 1977). Controlled-release transdermal nitroglycerin patches were included among the types of drugs permitted to remain on the market pending completion of efficacy studies based on their similarity to nitroglycerin ointment products (58 FR 38129 at 38130, July 15, 1993). In July 1993, FDA revoked the temporary exemption for single-entity coronary vasodilator products containing nitroglycerin in a transdermal delivery system, which had allowed the products to stay on the market beyond the time limit scheduled for the implementation of DESI (58 FR 38129). FDA found the products to be effective for prevention of angina pectoris caused by coronary artery disease, and required sponsors to submit bioavailability/bioequivalence studies within 1 year (see 58 FR 38129 at 38130 to 38131). In March 1999, FDA reclassified one NDA and five ANDAs for nitroglycerin transdermal systems to lacking substantial evidence of effectiveness, based on the sponsors' failure to submit the required bioavailability/bioequivalence data (64 FR 14451, March 25, 1999). In the March 1999 notice, FDA proposed to withdraw approval of the applications and offered an opportunity for a hearing on the proposal to withdraw the applications. In response to the March 1999 notice, Schwarz Pharma, Inc. (Schwarz Pharma), now a subsidiary of UCB, S.A., which was the sponsor of two of the five ANDAs, and Hercon Laboratories Corp. (Hercon), which was the sponsor of the remaining three ANDAs, requested hearings.\1\ G.D. Searle & Co., which was the sponsor of the identified NDA, did not submit a hearing request. --------------------------------------------------------------------------- \1\ The March 1999 notice incorrectly referred to Hercon as ``Hercon Pharmaceutical Company, Inc.'' --------------------------------------------------------------------------- At the request of Hercon, in the Federal Register of March 4, 2005 (70 FR 10651 at 10656), FDA withdrew approval of Hercon's three ANDAs that were the subject of the 1999 notice of opportunity for a hearing. On January 10, 2011, FDA sent a letter to Hercon to determine whether it remained interested in pursuing its hearing request. On February 9, 2011, Hercon responded by withdrawing its hearing request. On July 17, 2002, Schwarz Pharma withdrew its hearing request and requested withdrawal of its ANDAs that were the subject of the 1999 notice of opportunity for a hearing. There are no longer outstanding hearing requests for nitroglycerin drug products in transdermal systems under this docket. Therefore, as proposed in the March 1999 notice of opportunity for hearing, FDA finds that the following applications lack substantial evidence of effectiveness and hereby withdraws approval of the applications under section 505(e) of the FD&C Act (21 U.S.C. 355): ANDA 88-727, DEPONIT (release rate of 0.2 mg of nitroglycerin per hour), held by Schwarz Pharma; ANDA 89-022, DEPONIT (release rate of 0.4 mg of nitroglycerin per hour), held by Schwarz Pharma; and NDA 20-146, NITRODISC, held by G.D. Searle & Co. Shipment in interstate commerce of any nitroglycerin drug product in a transdermal system identified in this docket, or any IRS product, that is not the subject of an approved NDA or ANDA is unlawful as of the effective date of this notice (see DATES). Any person who wishes to determine whether a specific product is covered by this notice should write to Barbara Wise at the Center for Drug Evaluation and Research (see FOR FURTHER INFORMATION CONTACT). Firms should be aware that, after the effective date of this notice (see DATES), FDA intends to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice. III. Discontinued Products Firms must notify the Agency of certain product discontinuations in writing under section 506C(a) of the FD&C Act (21 U.S.C. 356c). See http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm. Some firms may have previously discontinued manufacturing or distributing products covered by this notice without discontinuing the listing as required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)). Other firms may discontinue manufacturing or distributing listed products in response to this notice. All firms are required to electronically update the listing of their products under section 510(j) of the FD&C Act to reflect discontinuation of unapproved products covered by this notice (21 CFR 207.21(b)). Questions on electronic drug listing updates should be sent to [email protected]. In addition to the required update, firms can also notify the Agency of product discontinuation by sending a letter, signed by the firm's chief executive officer and fully identifying the [[Page 70825]] discontinued product(s), including the product NDC number(s), and stating that the manufacturing and/or distribution of the product(s) have been discontinued. The letter should be sent electronically to Barbara Wise (see FOR FURTHER INFORMATION CONTACT). FDA plans to rely on its existing records, including its drug listing records, the results of any future inspections, or other available information, when it targets violative products for enforcement action. IV. Reformulated Products FDA cautions firms against reformulating products into unapproved new drugs and marketing under the same name or substantially the same name (including a new name that contains the old name). Reformulated products marketed under a name previously identified with a different active ingredient or combinations of active ingredients have the potential to confuse health care practitioners and harm patients. Dated: November 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-28853 Filed 11-13-15; 8:45 am] BILLING CODE 4164-01-P
![70822 Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices
judge, or perform a regulatory function previously participated in the ELP or research, manufacturing, academia, and
(e.g., compliance inspection), but rather, other FDA site visit programs. health care facilities. The focus areas
they are an opportunity to provide and specific areas of interest for visits
CDRH review staff a better II. CDRH ELP General Training
may include the following:
understanding of the products they Program
review. Through this notice, CDRH is A. Areas of Interest
formally requesting participation from
companies, academia, and clinical In this training program, groups of
facilities, including those that have CDRH staff will observe operations at
TABLE 1—AREAS OF INTEREST—OFFICE OF DEVICE EVALUATION
Focus area Specific areas of interest
Biocompatibility testing ................... Decision making process for biocompatibility evaluation and test selection (if needed); considerations for
use of animal testing vs. in vitro testing; sample preparation of nanoscale, bioabsorbable, and in situ po-
lymerized materials; evaluation of color additives.
Combination products ..................... Devices coated with drug(s) or biologic(s); drug/biologic delivery products.
Emerging manufacturing methods .. 3-D printing; additive manufacturing; additional or unique validation and verification activities.
Management of clinical trials for Conducting clinical trials, overcoming common obstacles to starting and completing clinical trials, and inter-
medical devices. acting with various other stakeholders; preparing applications to request approval to conduct Investiga-
tional Device Exemption (IDE) clinical studies and responding to feedback received from FDA.
Reprocessing and sterilization ........ Reprocessing challenges in clinical environment, including techniques for understanding and incorporating
these challenges from the clinical environment to labeling and validation studies; techniques for vali-
dating cleaning, disinfection, or sterilization instructions; challenges in validating cleaning, disinfection, or
sterilization instructions; simulated use testing, particularly for validating sterilization methods and in-
structions; unique sterilization methods (e.g., use of flexible bags, mixed sterilants sound waves, ultra-
violet light, microwave radiation).
TABLE 2—AREAS OF INTEREST—OFFICE OF IN VITRO DIAGNOSTIC DEVICES AND RADIOLOGICAL HEALTH
Focus area Specific areas of interest
Manufacturing of in vitro diagnostic Pre-analytical devices (i.e., blood tubes), pathogen collection devices, micro collection/transport devices;
devices. general reagents, manual reagents; general assays, common point-of-care devices.
Instrument training of medical de- Hands-on instrument and system training; clinical implication of common laboratory testing; hands on famil-
vices (manufacturer or clinical iarization of medical imaging equipment in a hospital setting.
laboratory).
Quality system in manufacturing Observation of implemented quality systems practices based on current Good Manufacturing Practices; the
environments based on 21 CFR manufacturing of medical imaging or therapeutic radiology technologies.
part 820.
B. Site Selection seen in the Division of Dockets Dated: November 5, 2015.
CDRH will be responsible for CDRH Management (see ADDRESSES) between 9 Leslie Kux,
staff travel expenses associated with the a.m. and 4 p.m., Monday through Associate Commissioner for Policy.
site visits. CDRH will not provide funds Friday. [FR Doc. 2015–28857 Filed 11–13–15; 8:45 am]
to support the training provided by the The proposal should include a BILLING CODE 4164–01–P
site to this ELP General Training description of your facility relative to
Program. Selection of potential facilities focus areas described in tables 1 or 2.
will be based on CDRH’s priorities for Please include the Area of Interest (see DEPARTMENT OF HEALTH AND
staff training and resources available to tables 1 or 2) that the site visit will HUMAN SERVICES
fund this program. In addition to demonstrate to CDRH staff, a contact
person, site visit location(s), length of Food and Drug Administration
logistical and other resource factors, all
sites must have a successful compliance site visit, proposed dates, and maximum [Docket No. FDA–1977–N–0356 (Formerly
record with FDA or another Agency number of CDRH staff that can be 77N–0240); DESI 1786]
with which FDA has a memorandum of accommodated during a site visit.
Proposals submitted without this Drugs for Human Use; Drug Efficacy
understanding. If a site visit involves a
minimum information will not be Study Implementation; Nitroglycerin
visit to a separate physical location of
considered. In addition, please include Transdermal Systems; Withdrawal of
another firm under contract with the
an agenda outlining the proposed Hearing Request; Withdrawal of
site, that firm must agree to participate
training for the site visit. A sample Applications; Final Resolution of
in the ELP General Training program
request and agenda are available on the Hearing Requests Regarding
and must also have a satisfactory
Transdermal Systems Under Docket
tkelley on DSK3SPTVN1PROD with NOTICES
compliance history. ELP Web site at http://www.fda.gov/
downloads/ScienceResearch/ ACTION: Notice.
III. Request To Participate ScienceCareerOpportunities/
Submit proposals for participation UCM392988.pdf and http:// SUMMARY: The Food and Drug
with the docket number found in the www.fda.gov/scienceresearch/ Administration (FDA or Agency) is
brackets in the heading of this sciencecareeropportunities/ announcing that all outstanding hearing
document. Received requests may be ucm380676.htm. requests regarding nitroglycerin drug
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![Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices 70825
discontinued product(s), including the 1–800–741–8138 (301–443–0572 in the New Hampshire Ave., Silver Spring, MD
product NDC number(s), and stating that Washington DC area), and follow the 20993–0002, 1–877–287–1373 (choose
the manufacturing and/or distribution of prompts to the desired center or product Option 5), FAX: 240–276–3655,
the product(s) have been discontinued. area. Please call the Information Line for TPSAC@fda.hhs.gov.
The letter should be sent electronically up-to-date information on this meeting. Information about becoming a
to Barbara Wise (see FOR FURTHER Dated: November 9, 2015.
member on an FDA advisory committee
INFORMATION CONTACT). FDA plans to can also be obtained by visiting FDA’s
Leslie Kux,
rely on its existing records, including its Web site by using the following link:
Associate Commissioner for Policy. http://www.fda.gov/
drug listing records, the results of any
[FR Doc. 2015–28846 Filed 11–13–15; 8:45 am] AdvisoryCommittees/default.htm.
future inspections, or other available
information, when it targets violative BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: FDA is
products for enforcement action. requesting nominations for voting
members on the Tobacco Products
IV. Reformulated Products DEPARTMENT OF HEALTH AND Scientific Advisory Committee.
FDA cautions firms against HUMAN SERVICES
I. General Description of the Committee
reformulating products into unapproved Food and Drug Administration Duties
new drugs and marketing under the
same name or substantially the same [Docket No. FDA–2009–N–0394] The Tobacco Products Scientific
name (including a new name that Advisory Committee (the Committee)
contains the old name). Reformulated Request for Nominations for Voting advises the Commissioner of Food and
products marketed under a name Members on a Public Advisory Drugs (the Commissioner) or designee in
previously identified with a different Committee; Tobacco Products discharging responsibilities related to
active ingredient or combinations of Scientific Advisory Committee the regulation of tobacco products. The
active ingredients have the potential to AGENCY: Food and Drug Administration, Committee reviews and evaluates safety,
confuse health care practitioners and HHS. dependence, and health issues relating
harm patients. to tobacco products and provides
ACTION: Notice. appropriate advice, information, and
Dated: November 9, 2015.
SUMMARY: The Food and Drug recommendations to the Commissioner.
Leslie Kux,
Administration (FDA) is requesting II. Criteria for Voting Members
Associate Commissioner for Policy.
nominations for voting members to
[FR Doc. 2015–28853 Filed 11–13–15; 8:45 am] The Committee consists of 12
serve on the Tobacco Products Scientific
BILLING CODE 4164–01–P members including the Chair. Members
Advisory Committee, Office of Science,
and the Chair are selected by the
Center for Tobacco Products.
FDA seeks to include the views of Commissioner or designee from among
DEPARTMENT OF HEALTH AND women and men, members of all racial individuals knowledgeable in the fields
HUMAN SERVICES and ethnic groups, and individuals with of medicine, medical ethics, science, or
and without disabilities on its advisory technology involving the manufacture,
Food and Drug Administration evaluation, or use of tobacco products.
committees and, therefore encourages
[Docket No. FDA–2015–N–0001] nominations of appropriately qualified Almost all non-Federal members of this
candidates from these groups. committee serve as Special Government
Gastroenterology and Urology Devices Employees. Members will be invited to
DATES: Nominations received on or
Panel of the Medical Devices Advisory serve for terms of up to 4 years. The
before January 15, 2016 will be given Committee includes nine technically
Committee; Amendment of Notice
first consideration for membership on qualified voting members, selected by
AGENCY: Food and Drug Administration, the Tobacco Products Scientific the Commissioner or designee. The nine
HHS. Advisory Committee. Nominations voting members include seven members
ACTION: Notice. received after January 15, 2016 will be who are physicians, dentists, scientists,
considered for nomination to the or health care professionals practicing
SUMMARY: The Food and Drug committee as later vacancies occur. in the area of oncology, pulmonology,
Administration (FDA) is canceling the ADDRESSES: All nominations for cardiology, toxicology, pharmacology,
November 18, 2015, session and membership should be sent addiction, or any other relevant
postponing the November 19, 2015, electronically by logging into the FDA specialty. The nine voting members also
session of the Gastroenterology and Advisory Committee Membership include one member who is an officer
Urology Devices Panel meeting. The Nomination Portal: http:// or employee of a state or local
meeting was announced in the Federal www.accessdata.fda.gov/scripts/ government or of the Federal
Register of October 7, 2015 (80 FR FACTRSPortal/FACTRS/index.cfm or by Government, and one member who is a
60686). The November 19, 2015, session mail to Advisory Committee Oversight representative of the general public.
has been postponed due to the and Management Staff, Food and Drug
cancellation of the November 18, 2015, Administration, 10903 New Hampshire III. Nomination Procedures
meeting. Future meeting dates will be Ave., Bldg. 32, Rm. 5103, Silver Spring, Any interested person may nominate
announced in the Federal Register. MD 20993–0002. one or more qualified individuals for
FOR FURTHER INFORMATION CONTACT: FOR FURTHER INFORMATION CONTACT: membership on the advisory committee.
tkelley on DSK3SPTVN1PROD with NOTICES
Patricio Garcia, Center for Devices and Regarding all nomination questions for Self-nominations are also accepted.
Radiological Health, Food and Drug membership, the primary contact is: Nominations must include a current,
Administration, 10903 New Hampshire Caryn Cohen, Office of Science, complete résumé or curriculum vitae for
Ave., Bldg. 66, Rm. 1535, Silver Spring Center for Tobacco Products, Food and each nominee, including current
MD 20993–0002, patricio.garcia@ Drug Administration, Center for business address and/or home address,
fda.hhs.gov, 301–796–6875, or FDA Tobacco Products, Document Control telephone number, and email address if
Advisory Committee Information Line, Center, Building 71, Rm. G335, 10903 available. Nominations must also
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Document Created: 2015-12-14 14:13:31
Document Modified: 2015-12-14 14:13:31
| 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. | |
| Contact | Barbara Wise, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5160, Silver Spring, MD 20993-0002, 301- 796-2089, email: [email protected] | |
| FR Citation | 80 FR 70822 |
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