83 FR 45937 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 176 (September 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 176 (September 11, 2018)
| Page Range | 45937-45940 | |
| FR Document | 2018-19664 |
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)] [Notices] [Pages 45937-45940] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19664] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3031] Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for tobacco product user fees. [[Page 45938]] DATES: Submit either electronic or written comments on the collection of information by November 13, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 13, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-3031 for ``Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products OMB Control Number 0910-0749--Extension On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. FDA issued a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the [[Page 45939]] FD&C Act. FDA expanded its authority over tobacco products by issuing another final rule, ``Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products'' (Deeming rule), deeming all products that meet the statutory definition of ``tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, the user fee final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA. As noted, FDA issued a final rule that requires domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the FD&C Act. The U. S. Department of Agriculture (USDA) had been collecting this information and provided FDA with the data the Agency needed to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA ceased collecting this information in fiscal year 2015 (October 2014). USDA's information collection did not require OMB approval, per an exemption by Public Law 108-357, section 642(b)(3). Consistent with the requirements of the FD&C Act, FDA requires the submission of this information to FDA now instead of USDA. FDA took this action to ensure that the Agency continues to have the information needed to calculate, assess, and collect user fees from domestic manufacturers and importers of tobacco products. Section 919(a) of the FD&C Act (21 U.S.C. 387s(a)) requires FDA to ``assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products'' subject to the tobacco product provisions of the FD&C Act (chapter IX of the FD&C Act). The total amount of user fees to be collected for each fiscal year is specified in section 919(b)(1) of the FD&C Act, and under section 919(a) FDA is to assess and collect a proportionate amount each quarter of the fiscal year. The FD&C Act provides for the total assessment to be allocated among the classes of tobacco products. The class allocation is based on each tobacco product class' volume of tobacco product removed into commerce. Within each class of tobacco products, an individual domestic manufacturer or importer is assessed a user fee based on its share of the market for that tobacco product class. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Hours per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 1150.5(a), (b)(1) and (2), and 658 12 7,896 3 23,688 Form FDA 3852; General identifying information provided by manufacturers and importers of FDA regulated tobacco products and identification and removal information (monthly).......... 1150.5(b)(3); Certified copies 658 12 7,896 1 7,896 (monthly)...................... 1150.13; Submission of user fee 329 4 1,316 1 1,316 information (Identifying information, fee amount, etc. (quarterly).................... 1150.15(a); Submission of user 5 1 5 10 50 fee dispute (annually)......... 1150.15(d); Submission of 3 1 3 10 30 request for further review of dispute of user fee (annually). ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 32,980 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that 658 entities will submit tobacco product user fees. The entity count was derived from aggregate data provided by the Alcohol and Tobacco Tax and Trade Bureau (TTB), and reflects that in 2017 there were 192 total permitted manufacturers and 466 permitted importers over all tobacco product types for which TTB collects excise taxes (including cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco, excluding electronic nicotine delivery systems). The estimate of 658 respondents to provide the information requested from Sec. 1150.5(a), (b)(1) and (2) (21 CFR 1150.5(a), (b)(1) and (2)), and Form FDA 3852 reflects both reports of no removal of tobacco products into domestic commerce and reports of removal of tobacco product into domestic commerce. FDA estimates it will take 3 hours for each of these submission types for a total of 23,688 hours. Under Sec. 1150.5(b)(3), these respondents are also expected to provide monthly certified copies of the returns and forms that relate to the removal of tobacco products into domestic commerce and the payment of Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986 to FDA. We estimate that each monthly report will take 1 hour for a total of 7,896 hours. The estimate of 329 respondents to submit payment of user fee information under Sec. 1150.13 reflects an average of half the number of domestic manufacturers and importers who may be subject to fees each fiscal quarter. FDA estimates the quarterly submission will take approximately 1 hour for a total of 1,316 hours. FDA estimates that five of those respondents assessed user fees will dispute the amounts under Sec. 1150.15(a), for a total amount of 50 hours. FDA also estimates that three respondents who dispute their user fees will ask for further review by FDA under Sec. 1150.15(d), for a total amount of 30 hours. FDA has only received one dispute submission since fiscal year 2015. Based on this data, the Agency does not believe we will receive more than five disputes and three requests for further reviews in the next 3 years. FDA estimates the total annual burden for this collection of information is 32,980 hours. The estimated burden for the information collection reflects an overall increase of 16,058 hours. We [[Page 45940]] attribute this adjustment to an increase in the number of entities submitting tobacco user fee information to FDA. Dated: September 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19664 Filed 9-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45937
Docket; Request for Comments.’’ Federal Register about last minute FDA is not responsible for providing
Received comments, those filed in a modifications that impact a previously access to electrical outlets.
timely manner (see ADDRESSES), will be announced advisory committee meeting For press inquiries, please contact the
placed in the docket and, except for cannot always be published quickly Office of Media Affairs at fdaoma@
those submitted as ‘‘Confidential enough to provide timely notice. fda.hhs.gov or 301–796–4540.
Submissions,’’ publicly viewable at Therefore, you should always check the FDA welcomes the attendance of the
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ public at its advisory committee
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and meetings and will make every effort to
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory accommodate persons with disabilities.
Friday. committee meeting link, or call the If you require accommodations due to a
• Confidential Submissions—To advisory committee information line to disability, please contact Jay Fajiculay
submit a comment with confidential learn about possible modifications (see FOR FURTHER INFORMATION CONTACT)
information that you do not wish to be before coming to the meeting. at least 7 days in advance of the
made publicly available, submit your SUPPLEMENTARY INFORMATION: meeting.
comments only as a written/paper Agenda: The committee will discuss FDA is committed to the orderly
submission. You should submit two new drug application (NDA) 210166 for conduct of its advisory committee
copies total. One copy will include the prucalopride tablets for oral meetings. Please visit our website at
information you claim to be confidential administration, submitted by Shire https://www.fda.gov/Advisory
with a heading or cover note that states Development, LLC, proposed for the Committees/AboutAdvisoryCommittees/
‘‘THIS DOCUMENT CONTAINS treatment of chronic idiopathic ucm111462.htm for procedures on
CONFIDENTIAL INFORMATION.’’ FDA constipation in adults. public conduct during advisory
will review this copy, including the FDA intends to make background committee meetings.
claimed confidential information, in its material available to the public no later Notice of this meeting is given under
consideration of comments. The second than 2 business days before the meeting. the Federal Advisory Committee Act (5
copy, which will have the claimed If FDA is unable to post the background U.S.C. app. 2).
confidential information redacted/ material on its website prior to the
meeting, the background material will Dated: September 4, 2018.
blacked out, will be available for public
be made publicly available at the Leslie Kux,
viewing and posted on https://
www.regulations.gov. Submit both location of the advisory committee Associate Commissioner for Policy.
copies to the Dockets Management Staff. meeting, and the background material [FR Doc. 2018–19670 Filed 9–10–18; 8:45 am]
If you do not wish your name and will be posted on FDA’s website after BILLING CODE 4164–01–P
contact information be made publicly the meeting. Background material is
available, you can provide this available at https://www.fda.gov/
information on the cover sheet and not AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND
in the body of your comments and you default.htm. Scroll down to the HUMAN SERVICES
must identify the information as appropriate advisory committee meeting
link. Food and Drug Administration
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed Procedure: Interested persons may
present data, information, or views, [Docket No. FDA–2018–N–3031]
except in accordance with 21 CFR 10.20
orally or in writing, on issues pending
and other applicable disclosure law. For
before the committee. All electronic and Agency Information Collection
more information about FDA’s posting
written submissions submitted to the Activities; Proposed Collection;
of comments to public dockets, see 80
Docket (see ADDRESSES) on or before Comment Request; Tobacco Products,
FR 56469, September 18, 2015, or access
October 9, 2018, will be provided to the User Fees, Requirements for the
the information at: https://www.gpo.gov/
committee. Oral presentations from the Submission of Data Needed To
fdsys/pkg/FR-2015-09-18/pdf/2015-
public will be scheduled between Calculate User Fees for Domestic
23389.pdf.
approximately 1 p.m. and 2 p.m. Those Manufacturers and Importers of
Docket: For access to the docket to
individuals interested in making formal Tobacco Products
read background documents or the oral presentations should notify the
electronic and written/paper comments contact person and submit a brief AGENCY: Food and Drug Administration,
received, go to https:// statement of the general nature of the HHS.
www.regulations.gov and insert the evidence or arguments they wish to ACTION: Notice.
docket number, found in brackets in the present, the names and addresses of
heading of this document, into the proposed participants, and an SUMMARY: The Food and Drug
‘‘Search’’ box and follow the prompts indication of the approximate time Administration (FDA or Agency) is
and/or go to the Dockets Management requested to make their presentation on announcing an opportunity for public
Staff, 5630 Fishers Lane, Rm. 1061, or before October 1, 2018. Time allotted comment on the proposed collection of
Rockville, MD 20852. for each presentation may be limited. If certain information by the Agency.
FOR FURTHER INFORMATION CONTACT: Jay the number of registrants requesting to Under the Paperwork Reduction Act of
R. Fajiculay, Center for Drug Evaluation speak is greater than can be reasonably 1995 (PRA), Federal Agencies are
and Research, Food and Drug accommodated during the scheduled required to publish notice in the
Administration, 10903 New Hampshire open public hearing session, FDA may Federal Register concerning each
daltland on DSKBBV9HB2PROD with NOTICES
Ave., Bldg. 31, Rm. 2417, Silver Spring, conduct a lottery to determine the proposed collection of information,
MD 20993–0002, 301–796–9001, Fax: speakers for the scheduled open public including each proposed extension of an
301–847–8533, email: GIDAC@ hearing session. The contact person will existing collection of information, and
fda.hhs.gov, or FDA Advisory notify interested persons regarding their to allow 60 days for public comment in
Committee Information Line, 1–800– request to speak by October 2, 2018. response to the notice. This notice
741–8138 (301–443–0572 in the Persons attending FDA’s advisory solicits comments on the information
Washington, DC area). A notice in the committee meetings are advised that collection for tobacco product user fees.
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![45940 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices
attribute this adjustment to an increase The 1984 amendments include what Streptococcus pneumoniae,
in the number of entities submitting is now section 505(j)(7) of the Federal Haemophilus influenzae (including b-
tobacco user fee information to FDA. Food, Drug, and Cosmetic Act (FD&C lactamase-producing strains), and
Dated: September 4, 2018. Act) (21 U.S.C. 355(j)(7)), which Moraxella (Branhamella) catarrhalis
Leslie Kux,
requires FDA to publish a list of all (including b-lactamase-producing
approved drugs. FDA publishes this list strains);
Associate Commissioner for Policy.
as part of the ‘‘Approved Drug Products • Lower respiratory tract: Acute
[FR Doc. 2018–19664 Filed 9–10–18; 8:45 am] With Therapeutic Equivalence bacterial exacerbation of chronic
BILLING CODE 4164–01–P Evaluations,’’ which is known generally bronchitis caused by Streptococcus
as the ‘‘Orange Book.’’ Under FDA pneumoniae, Haemophilus influenzae
regulations, drugs are removed from the (including b-lactamase-producing
DEPARTMENT OF HEALTH AND list if the Agency withdraws or strains), and Moraxella (Branhamella)
HUMAN SERVICES suspends approval of the drug’s NDA or catarrhalis (including b-lactamase-
ANDA for reasons of safety or producing strains); and
Food and Drug Administration
effectiveness or if FDA determines that • Skin and skin structure:
[Docket No. FDA–2018–N–3262] the listed drug was withdrawn from sale Uncomplicated skin and skin-structure
for reasons of safety or effectiveness (21 infections caused by Staphylococcus
Determination That CEFZIL (Cefprozil) CFR 314.162). aureus (including penicillinase-
Tablets, 250 Milligrams and 500 A person may petition the Agency to producing strains) and Streptococcus
Milligrams, and for Oral Suspension, determine, or the Agency may pyogenes. Abscesses usually require
125 Milligrams/5 Milliliters and 250 determine on its own initiative, whether surgical drainage.
Milligrams/5 Milliliters, Were Not a listed drug was withdrawn from sale In a letter dated September 7, 2010,
Withdrawn From Sale for Reasons of for reasons of safety or effectiveness. Bristol-Myers Squibb 1 notified FDA that
Safety or Effectiveness This determination may be made at any CEFZIL (cefprozil) tablets, 250 mg and
AGENCY: Food and Drug Administration, time after the drug has been withdrawn 500 mg and CEFZIL (cefprozil) for oral
HHS. from sale, but must be made prior to suspension, 125 mg/5 mL and 250 mg/
approving an ANDA that refers to the 5 mL, were discontinued from sale, and
ACTION: Notice. listed drug (§ 314.161 (21 CFR 314.161)). FDA moved the drug products to the
SUMMARY: The Food and Drug FDA may not approve an ANDA that ‘‘Discontinued Drug Product List’’
Administration (FDA or Agency) has does not refer to a listed drug. section of the Orange Book. Later,
determined that CEFZIL (cefprozil) Under § 314.161(a)(2), the Agency Corden Pharma Latina S.p.A. notified
tablets, 250 milligrams (mg) and 500 mg must also determine whether a listed the Agency in writing that these drug
and CEFZIL (cefprozil) for oral drug was withdrawn from sale for products were no longer marketed and
suspension, 125 mg/5 milliliters (mL) reasons of safety or effectiveness if requested that the approval of the
and 250 mg/5 mL were not withdrawn ANDAs that referred to the listed drug applications be withdrawn. In the
from sale for reasons of safety or have already been approved prior to its Federal Register of June 21, 2017 (82 FR
effectiveness. This determination will market withdrawal. If the Agency 28322 at 28326), the Agency issued a
allow FDA to continue to approve determines that a listed drug was notice withdrawing approval of the
abbreviated new drug applications withdrawn from sale for reasons of applications, effective July 21, 2017.
safety or effectiveness, and there are After reviewing Agency records and
(ANDAs) that refer to these drugs as
approved ANDAs that reference that based on the information we have at this
long as they meet relevant legal and
listed drug, FDA will initiate a time, FDA has determined under
regulatory requirements.
proceeding to determine whether the § 314.161 that CEFZIL (cefprozil)
FOR FURTHER INFORMATION CONTACT: suspension of the ANDAs is also
Diana J. Pomeranz, Center for Drug tablets, 250 mg and 500 mg, and CEFZIL
required (21 CFR 314.153(b)). (cefprozil) for oral suspension, 125 mg/
Evaluation and Research, Food and CEFZIL (cefprozil) tablets, 250 mg and
Drug Administration, 10903 New 5 mL and 250 mg/5 mL, were not
500 mg, are the subject of NDA 050664 withdrawn from sale for reasons of
Hampshire Ave., Bldg. 51, Rm. 6288, held by Corden Pharma Latina S.p.A.,
Silver Spring, MD 20993–0002, 240– safety or effectiveness.
and initially approved on December 23, We note that CEFZIL (cefprozil)
402–4654. 1991. CEFZIL (cefprozil) for oral tablets, 250 mg and 500 mg, and CEFZIL
SUPPLEMENTARY INFORMATION: In 1984, suspension, 125 mg/5 mL and 250 mg/ (cefprozil) for oral suspension, 125 mg/
Congress enacted the Drug Price 5 mL, is the subject of NDA 050665 held 5 mL and 250 mg/5 mL, previously were
Competition and Patent Term by Corden Pharma Latina S.p.A., and approved with an indication for
Restoration Act of 1984 (Pub. L. 98–417) initially approved on December 23, secondary bacterial infection of acute
(the 1984 amendments), which 1991. CEFZIL is indicated for the bronchitis (SBIAB). On October 3, 2016,
authorized the approval of duplicate treatment of patients with mild to FDA sent Corden Pharma Latina S.p.A.
versions of drug products under an moderate infections caused by a Prior Approval Supplement Request
ANDA procedure. ANDA applicants susceptible strains of the designated letter seeking removal of the SBIAB
must, with certain exceptions, show that microorganisms in the conditions listed indication from the labeling of these
the drug for which they are seeking below: drug products. In response, on October
approval contains the same active • Upper respiratory tract: Pharyngitis/ 28, 2016, Corden Pharma Latina S.p.A.
ingredient in the same strength and tonsillitis caused by Streptococcus submitted supplements proposing to
daltland on DSKBBV9HB2PROD with NOTICES
dosage form as the ‘‘listed drug,’’ which pyogenes; otitis media caused by remove the indication. On November
is a version of the drug that was Streptococcus pneumoniae, 22, 2016, FDA approved these
previously approved. ANDA applicants Haemophilus influenzae (including b- supplements and the indication was
do not have to repeat the extensive lactamase-producing strains), and
clinical testing otherwise necessary to Moraxella (Branhamella) catarrhalis 1 On May 26, 2011, Bristol-Myers Squibb
gain approval of a new drug application (including b-lactamase-producing transferred ownership of NDA 050664 and NDA
(NDA). strains); and acute sinusitis caused by 050665 to Corden Pharma Latina S.p.A.
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Document Created: 2018-09-11 01:03:07
Document Modified: 2018-09-11 01:03:07
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by November 13, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 45937 |
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