83 FR 7735 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 36 (February 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 36 (February 22, 2018)
| Page Range | 7735-7738 | |
| FR Document | 2018-03609 |
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)] [Notices] [Pages 7735-7738] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03609] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0341] Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 reporting and recordkeeping requirements of our regulations concerning new animal drugs for investigational use. DATES: Submit either electronic or written comments on the collection of information by April 23, 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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 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''). [[Page 7736]] 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-0341 for ``New Animal Drugs for Investigational Use.'' 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. New Animal Drugs for Investigational Use--21 CFR Part 511 OMB Control Number 0910-0117--Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs. A new animal drug application (NADA) cannot be approved until, among other things, the new animal drug has been demonstrated to be safe and effective for its intended use(s). In order to properly test a new animal drug for an intended use, appropriate scientific investigations must be conducted. Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C. 360b(j)) permits the use of an investigational new animal drug to generate data to support an NADA approval. Section 512(j) of the FD&C Act authorizes us to issue regulations relating to the investigational use of new animal drugs. Our regulations in part 511 (21 CFR part 511) set forth the conditions for investigational use of new animal drugs and require reporting and recordkeeping. The information collected is necessary to protect the public health. We use the information to determine that investigational animal drugs are distributed only to qualified investigators, adequate drug accountability records are maintained, and edible food products from treated food-producing animals are safe for human consumption. We also use the information collected to monitor the validity of the studies submitted to us to support new animal drug approval. Reporting: Our regulations require that certain information be submitted to us in a ``Notice of Claimed Investigational Exemption for a New Animal Drug'' (NCIE) to qualify for the exemption and to control shipment of the new animal drug and prevent potential abuse. The NCIE must contain, among other things, the following specific information: (1) Identity of the new animal drug, (2) labeling, (3) statement of compliance of any non-clinical laboratory studies with good laboratory practices, (4) name and address of each clinical investigator, (5) the approximate number of animals to be treated or amount of new animal drug(s) to be shipped, and (6) information regarding the use of edible tissues from investigational animals (Sec. 511.1(b)(4) (21 CFR 511.1(b)(4)). If the new animal drug is to be used in food-producing animals, e.g., cattle, swine, chickens, fish, etc., certain data must be submitted to us to obtain authorization for the use of edible food products from treated food-producing animals (Sec. 511.1(b)(5)). We require sponsors upon request to submit information with respect to the investigation to determine whether there are grounds for terminating the exemption (Sec. 511.1(b)(6)). We require sponsors to report findings that may suggest significant hazards pertinent to the safety of the new animal drug (Sec. 511.1(b)(8)(ii)). We also require [[Page 7737]] reporting by importers of investigational new animal drugs for clinical investigational use in animals (Sec. 511.1(b)(9)). The information provided by the sponsor in the NCIE is needed to ensure that the proposed investigational use of the new animal drug is safe and that any edible food will not be distributed without proper authorization from FDA. Information contained in an NCIE submission is monitored under our Bio-Research Monitoring Program. This program permits us to monitor the validity of the studies and to ensure the proper use of the drugs is maintained by the investigators. Recordkeeping: If the new animal drug is only for tests in vitro or in laboratory research animals, the person distributing the new animal drug must maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment or delivery (Sec. 511.1(a)(3) and (b)(3)). We require complete records of the investigation, including records of the receipt and disposition of each shipment or delivery of the investigational new animal drug (Sec. 511.1(b)(7)). We also require records of all reports received by a sponsor from investigators to be retained for 2 years after the termination of an investigational exemption or approval of a new animal drug application (Sec. 511.1(b)(8)(i)). Description of Respondents: Respondents to this collection of information are persons who use new animal drugs for investigational purposes. Investigational new animal drugs are used primarily by drug industry firms, academic institutions, and the government. Investigators may include individuals from these entities, as well as research firms and members of the medical professions. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section/activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 511.1(b)(4); submission of NCIE. 104 15.38 1,600 1 1,600 511.1(b)(5); submission of data 104 0.30 31 8 248 to obtain authorization for the use of edible food products.... 511.1(b)(6); submission of any 104 0.02 2 1 2 additional information upon request of FDA................. 511.1(b)(8)(ii); reporting of 104 0.14 15 2 30 findings that may suggest significant hazards pertinent to the safety of the new animal drug........................... 511.1(b)(9); reporting by 104 0.14 15 8 120 importers of investigational new animal drugs for clinical investigational use in animals. ------------------------------------------------------------------------------- Total....................... .............. .............. 1,663 .............. 2,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR Section/activity Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 511.1(a)(3); maintain records 104 2.5 260 1 260 showing the name and post office address of the expert or expert organization to whom the new animal drug is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment or delivery....................... 511.1(b)(3); maintain records 104 15.38 1,600 1 1,600 showing the name and post office address of the expert or expert organization to whom the new animal drug or feed containing same is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment or delivery....................... 511.1(b)(7); maintain records of 104 15.38 1,600 3.5 5,600 the investigation, including records of the receipt and disposition of each shipment or delivery of the investigational new animal drug................ 511.1(b)(8)(i); maintain records 104 15.38 1,600 3.5 5,600 of all reports received by a sponsor from investigators..... ------------------------------------------------------------------------------- Total....................... .............. .............. 5,060 .............. 13,060 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the time required for reporting requirements, record preparation, and maintenance for this collection of information is based on our informal communication with industry. Based on the number of sponsors subject to animal drug user fees, we estimate that there are 104 respondents. We use this estimate consistently throughout the table and calculate the ``number of responses per respondent'' by dividing the total annual responses by number of respondents. Additional information needed to make a final calculation of the total burden hours [[Page 7738]] (i.e., the number of respondents, the number of recordkeepers, the number of NCIEs received, etc.) is derived from our records. The burden for this information collection has changed since the last OMB approval. We estimate an overall increase in burden that we attribute to an increase in the number of annual responses and records. Dated: February 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03609 Filed 2-21-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7735
actual amount of extension that the 202207 was approved on March 13, announcing an opportunity for public
Director of USPTO may award (for 2013. comment on the proposed collection of
example, half the testing phase must be This determination of the regulatory certain information by the Agency.
subtracted as well as any time that may review period establishes the maximum Under the Paperwork Reduction Act of
have occurred before the patent was potential length of a patent extension. 1995 (PRA), Federal Agencies are
issued), FDA’s determination of the However, the USPTO applies several required to publish notice in the
length of a regulatory review period for statutory limitations in its calculations Federal Register concerning each
a human drug product will include all of the actual period for patent extension. proposed collection of information,
of the testing phase and approval phase In its application for patent extension, including each proposed extension of an
as specified in 35 U.S.C. 156(g)(1)(B). this applicant seeks 1,826 days of patent existing collection of information, and
FDA has approved for marketing the term extension. to allow 60 days for public comment in
human drug product LYMPHOSEEK response to the notice. This notice
III. Petitions
(technetium (Tc 99m) tilmanocept). solicits comments on the reporting and
LYMPHOSEEK is indicated for Anyone with knowledge that any of
recordkeeping requirements of our
lymphatic mapping with a hand-held the dates as published are incorrect may
regulations concerning new animal
gamma counter to assist in the submit either electronic or written
comments and under 21 CFR 60.24, ask drugs for investigational use.
localization of lymph nodes draining a
primary tumor site in patients with for a redetermination (see DATES). DATES: Submit either electronic or
breast cancer or melanoma. Subsequent Furthermore, as specified in § 60.30 (21 written comments on the collection of
to this approval, the USPTO received a CFR 60.30), any interested person may information by April 23, 2018.
patent term restoration application for petition FDA for a determination
regarding whether the applicant for ADDRESSES: You may submit comments
LYMPHOSEEK (U.S. Patent No.
extension acted with due diligence as follows. Please note that late,
6,409,990) from Navidea
during the regulatory review period. To untimely filed comments will not be
Biopharmaceuticals, Inc., and the
meet its burden, the petition must considered. Electronic comments must
USPTO requested FDA’s assistance in
determining this patent’s eligibility for comply with all the requirements of be submitted on or before April 23,
patent term restoration. In a letter dated § 60.30, including but not limited to: 2018. The https://www.regulations.gov
November 4, 2015, FDA advised the must be timely (see DATES), must be electronic filing system will accept
USPTO that this human drug product filed in accordance with § 10.20, must comments until midnight Eastern Time
had undergone a regulatory review contain sufficient facts to merit an FDA at the end of April 23, 2018. Comments
period and that the approval of investigation, and must certify that a received by mail/hand delivery/courier
LYMPHOSEEK represented the first true and complete copy of the petition (for written/paper submissions) will be
permitted commercial marketing or use has been served upon the patent considered timely if they are
of the product. Thereafter, the USPTO applicant. (See H. Rept. 857, part 1, 98th postmarked or the delivery service
requested that FDA determine the Cong., 2d sess., pp. 41–42, 1984.) acceptance receipt is on or before that
product’s regulatory review period. Petitions should be in the format date.
specified in 21 CFR 10.30. Electronic Submissions
II. Determination of Regulatory Review Submit petitions electronically to
Period https://www.regulations.gov at Docket Submit electronic comments in the
FDA has determined that the No. FDA–2013–S–0610. Submit written following way:
applicable regulatory review period for petitions (two copies are required) to the • Federal eRulemaking Portal:
LYMPHOSEEK is 4,398 days. Of this Dockets Management Staff (HFA–305), https://www.regulations.gov. Follow the
time, 3,816 days occurred during the Food and Drug Administration, 5630 instructions for submitting comments.
testing phase of the regulatory review Fishers Lane, Rm. 1061, Rockville, MD Comments submitted electronically,
period, while 582 days occurred during 20852. including attachments, to https://
the approval phase. These periods of Dated: February 15, 2018. www.regulations.gov will be posted to
time were derived from the following Leslie Kux, the docket unchanged. Because your
dates: comment will be made public, you are
Associate Commissioner for Policy.
1. The date an exemption under
[FR Doc. 2018–03610 Filed 2–21–18; 8:45 am] solely responsible for ensuring that your
section 505(i) of the Federal Food, Drug,
comment does not include any
and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P
confidential information that you or a
U.S.C. 355(i)) became effective:
third party may not wish to be posted,
February 28, 2001. FDA has verified the
DEPARTMENT OF HEALTH AND such as medical information, your or
applicant’s claim that the date the
HUMAN SERVICES anyone else’s Social Security number, or
investigational new drug application
confidential business information, such
became effective was on February 28, Food and Drug Administration as a manufacturing process. Please note
2001.
2. The date the application was [Docket No. FDA–2018–N–0341] that if you include your name, contact
initially submitted with respect to the information, or other information that
human drug product under section Agency Information Collection identifies you in the body of your
505(b) of the FD&C Act: August 10, Activities; Proposed Collection; comments, that information will be
2011. FDA has verified the applicant’s Comment Request; New Animal Drugs posted on https://www.regulations.gov.
daltland on DSKBBV9HB2PROD with NOTICES
claim that the new drug application for Investigational Use • If you want to submit a comment
(NDA) for LYMPHOSEEK (NDA 202207) AGENCY: Food and Drug Administration, with confidential information that you
was initially submitted on August 10, HHS. do not wish to be made available to the
2011. ACTION: Notice. public, submit the comment as a
3. The date the application was written/paper submission and in the
approved: March 13, 2013. FDA has SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
verified the applicant’s claim that NDA Administration (FDA, Agency, or we) is Submissions’’ and ‘‘Instructions’’).
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![7738 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
(i.e., the number of respondents, the DEPARTMENT OF HEALTH AND DATES:Approval is withdrawn as of
number of recordkeepers, the number of HUMAN SERVICES March 26, 2018.
NCIEs received, etc.) is derived from our
Food and Drug Administration FOR FURTHER INFORMATION CONTACT:
records. The burden for this information
Florine P. Purdie, Center for Drug
collection has changed since the last [Docket No. FDA–2018–N–0508] Evaluation and Research, Food and
OMB approval. We estimate an overall
Parke-Davis, Subsidiary of Pfizer, Inc. Drug Administration, 10903 New
increase in burden that we attribute to
et al.; Withdraw of Approval of 38 New Hampshire Ave., Bldg. 51, Rm. 6248,
an increase in the number of annual
Drug Applications and 43 Abbreviated Silver Spring, MD 20993–0002, 301–
responses and records.
New Drug Applications 796–3601.
Dated: February 15, 2018.
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: The
Leslie Kux,
HHS. holders of the applications listed in the
Associate Commissioner for Policy. table have informed FDA that these drug
ACTION: Notice.
[FR Doc. 2018–03609 Filed 2–21–18; 8:45 am] products are no longer marketed and
BILLING CODE 4164–01–P SUMMARY: The Food and Drug have requested that FDA withdraw
Administration (FDA or Agency) is approval of the applications under the
withdrawing approval of 38 new drug process in § 314.150(c) (21 CFR
applications (NDAs) and 43 abbreviated 314.150(c)). The applicants have also,
new drug applications (ANDAs) from by their requests, waived their
multiple applicants. The holders of the opportunity for a hearing. Withdrawal
applications notified the Agency in of approval of an application or
writing that the drug products were no
abbreviated application under
longer marketed and requested that the
§ 314.150(c) is without prejudice to
approval of the applications be
withdrawn. refiling.
TABLE 1
Application No. Drug Applicant
NDA 010151 ...... Dilantin (phenytoin sodium) Injection USP, 50 milligrams Parke-Davis, Subsidiary of Pfizer, Inc., 235 East 42nd St.,
(mg)/milliliter (mL). New York, NY 10017.
NDA 011903 ...... Zolyse (chymotrypsin) for Ophthalmic Solution, 750 units/vial Alcon Laboratories, Inc., 6201 S. Freeway, TC–45, Fort
Worth, TX 76134–2099.
NDA 012125 ...... Carbocaine (mepivacaine hydrochloride (HCl)) Injection USP, Hospira Inc., 8401 W. 102nd St., Pleasant Prairie, WI 53158.
3%.
Carbocaine with Neo-Cobefrin (mepivacaine HCl;
levonordefrin) Injection USP, 2%; 0.05 mg/mL.
NDA 012516 ...... Sansert (methysergide maleate) Tablets, 2 mg ...................... Novartis Pharmaceuticals Corp., One Health Pl., East Han-
over, NJ 07936–1080.
NDA 016774 ...... Serentil (mesoridazine besylate) Tablets, Equivalent to (EQ) Do.
10 mg base, 25 mg base, 50 mg base, and 100 mg base.
NDA 016775 ...... Serentil (mesoridazine besylate) Injection, EQ 25 mg base/ Do.
mL.
NDA 016793 ...... Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham,
mg/vial, 1 gram (g)/vial, and 2 g/vial. PA 19044.
NDA 016997 ...... Serentil (mesoridazine besylate) Oral Concentrate, EQ 25 Novartis Pharmaceuticals Corp.
mg base/mL.
NDA 017364 ...... Aquatensen (methyclothiazide) Tablets USP, 5 mg ................ Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 400,
Somerset, NJ 08873.
NDA 017575 ...... DTIC-Dome (dacarbazine) for Injection, 100 mg/vial and 200 Bayer Healthcare Pharmaceuticals, Inc., 100 Bayer Blvd.,
mg/vial. Whippany, NJ 07981.
NDA 017717 ...... Gyne-Lotrimin (clotrimazole) Vaginal Tablets, 100 mg ........... Bayer HealthCare, LLC, 100 Bayer Blvd., P.O. Box 915,
Whippany, NJ 07981–0915.
NDA 017869 ...... Funduscein-25 (fluorescein sodium) Injection, 25% ................ Novartis Pharmaceuticals Corp.
NDA 017993 ...... Hydergine (ergoloid mesylates) Tablets, 0.5 mg and 1 mg .... Do.
NDA 018052 ...... Gyne-Lotrimin (clotrimazole) Vaginal Cream, 1% ................... Bayer HealthCare, LLC.
NDA 018128 ...... Ovcon-50 (norethindrone and ethinyl estradiol) Tablets USP Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC,
(21-Day Regimen), 1 mg and 0.05 mg. 100 Enterprise Dr., Rockaway, NJ 07866.
NDA 018397 ...... Chlor-Trimeton (chlorpheniramine maleate and Bayer HealthCare, LLC.
pseudoephedrine sulfate) Extended-Release Tablets, 8 mg
and 120 mg.
NDA 018418 ...... Hydergine (ergoloid mesylates) Oral Solution, 1 mg/mL ......... Novartis Pharmaceuticals Corp.
NDA 018439 ...... Multi-Vitamins Concentrate for Infusion, Injection ................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
daltland on DSKBBV9HB2PROD with NOTICES
NDA 018471 ...... Ocuclear (oxymetazoline HCl) Ophthalmic Solution, 0.025% Bayer HealthCare, LLC.
NDA 018517 ...... Metronidazole Tablets USP, 250 mg and 500 mg .................. IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
NDA 018969 ...... Liposyn III 10% (soybean oil) Injection, 10% .......................... Hospira, Inc.
NDA 020045 ...... Shade UVAGuard (avobenzone, octinoxate, oxybenzone) Lo- Bayer HealthCare, LLC.
tion, 3%/7.5%/3%.
NDA 020289 ...... Gyne-Lotrimin Combination Pack (clotrimazole) Vaginal Do.
Cream and Vaginal Tablets, 1% and 100 mg.
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Document Created: 2018-02-22 02:51:10
Document Modified: 2018-02-22 02:51:10
| 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 April 23, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 7735 |
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