83 FR 35655 - Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 145 (July 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35655-35657 | |
| FR Document | 2018-16027 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35655-35657] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16027] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6380] Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' FDA does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug [[Page 35656]] in the non-orphan adult population of that disease, get a pediatric- subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication. DATES: The announcement of the guidance is published in the Federal Register on July 27, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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-2017-D-6380 for ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Office of Orphan Products Development, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Aaron Friedman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5209, Silver Spring, MD 20993, 301-796-2989. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a final guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' In the Federal Register of December 20, 2017 (82 FR 60402), FDA published a notice of availability for the draft guidance entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases,'' announcing that FDA does not expect to grant any additional orphan drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of over 200,000 in the United States). In the Federal Register of January 12, 2018 (83 FR 1619), FDA announced that it was extending the comment period for this draft guidance for an additional 30 days. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated December 2017. FDA does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric-subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on orphan designation of drugs and biologics for pediatric subpopulations of common diseases. It does not establish any rights for any person and is not binding on FDA or the [[Page 35657]] public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Orphan or https://www.regulations.gov. Dated: July 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16027 Filed 7-26-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35655
Application No. Drug Applicant
ANDA 064201 .... Cefotaxime for Injection USP, EQ 10 g base/vial and EQ 20 Do.
g base/vial.
ANDA 065251 .... Cefuroxime for Injection USP, EQ 75 g base/bag and EQ Samson Medical Technologies, LLC, 2050 Springdale Rd.,
225 g base/bag (Pharmacy Bulk Package). P.O. Box 2730, Suite 400, Cherry Hill, NJ 08034.
ANDA 070892 .... Metoclopramide Hydrochloride (HCl) Injection, EQ 10 mg Norbrook Laboratories, Ltd., c/o Norbrook, Inc., 9401 Indian
base/2 milliliters (mL). Creek Pkwy., Suite 680, Overland Park, KS 66210.
ANDA 075309 .... Ticlopidine HCl Tablets USP, 250 mg ..................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 076797 .... Risperidone Oral Solution USP, 1 mg/mL ............................... Precision Dose, Inc., 722 Progressive Lane, South Beloit, IL
61080.
ANDA 077656 .... Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 4 mg GlaxoSmithKline Consumer Healthcare, 184 Liberty Corner
base. Rd., Suite 200, Warren, NJ 07059.
ANDA 077658 .... Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 2 mg Do.
base.
ANDA 080188 .... Testosterone Propionate Injection USP, 25 mg/mL, 50 mg/ Watson Laboratories, Inc., Subsidiary of Teva Pharma-
mL, and 100 mg/mL. ceuticals USA, Inc.
ANDA 083398 .... Prednisolone Acetate Injectable Suspension, 25 mg/mL ........ Do.
ANDA 083764 .... Prednisolone Acetate Injectable Suspension, 50 mg/mL ........ Do.
ANDA 084072 .... Triamcinolone Diacetate Injection, 40 mg/mL ......................... Do.
ANDA 084270 .... Triamcinolone Tablets USP, 4 mg ........................................... Do.
ANDA 084466 .... Reserpine and Hydrochlorothiazide Tablets, 0.125 mg/25 mg Do.
ANDA 084604 .... Procainamide HCl Capsules, 250 mg ...................................... Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 085693 .... Phentermine HCl Tablets USP, 8 mg ...................................... Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 085863 .... Theophylline Elixir, 80 mg/15 mL ............................................ Precision Dose, Inc.
ANDA 087185 .... Ergoloid Mesylates Sublingual Tablets USP, 1 mg ................. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 087770 .... Sulfinpyrazone Capsules USP, 200 mg .................................. Do.
ANDA 088648 .... Methotrexate Injection USP, EQ 25 mg base/mL ................... Norbrook Laboratories, Ltd., c/o Norbrook, Inc.
ANDA 088928 .... Chlorzoxazone Tablets USP, 250 mg ..................................... Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
ANDA 090663 .... Gemcitabine for Injection USP, EQ 200 mg base/vial and EQ Hameln RDS GmbH, c/o B&H Consulting Services, Inc., 50
1 g base/vial. Division St., Suite 206, Somerville, NJ 08876.
ANDA 091469 .... Vancomycin HCl for Injection USP, EQ 10 g base/vial (Phar- Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
macy Bulk Package). 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV
26504.
ANDA 202390 .... Tramadol HCl Tablets USP, 50 mg ......................................... Accord Healthcare, Inc., 1009 Slater Rd., Suite 210–B, Dur-
ham, NC 27703.
ANDA 203506 .... Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
10 mg, 15 mg, 20 mg, 30 mg, and 40 mg. Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
ANDA 204320 .... Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., 440 U.S.
15 mg, and 20 mg. Highway 22 East, One Grande Commons, Suite 150,
Bridgewater, NJ 08807.
ANDA 204706 .... Olopatadine HCl Ophthalmic Solution USP, EQ 0.1% base ... Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC,
9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242.
ANDA 207467 .... Nevirapine Extended-Release Tablets, 100 mg and 400 mg Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
Therefore, approval of the Dated: July 23, 2018. ACTION: Notice of availability.
applications listed in the table, and all Leslie Kux,
amendments and supplements thereto, Associate Commissioner for Policy.
SUMMARY: The Food and Drug
is hereby withdrawn as of August 27, Administration (FDA or Agency) is
[FR Doc. 2018–16037 Filed 7–26–18; 8:45 am]
announcing the availability of a final
2018. Introduction or delivery for BILLING CODE 4164–01–P
guidance for industry entitled
introduction into interstate commerce of
‘‘Clarification of Orphan Designation of
products without approved new drug Drugs and Biologics for Pediatric
applications violates section 301(a) and DEPARTMENT OF HEALTH AND
Subpopulations of Common Diseases.’’
(d) of the Federal Food, Drug, and HUMAN SERVICES
FDA does not expect to grant any
Cosmetic Act (21 U.S.C. 331(a) and (d)). additional orphan-drug designation to
Food and Drug Administration
Drug products that are listed in the table drugs for pediatric subpopulations of
that are in inventory on August 27, 2018 common diseases (i.e., diseases or
may continue to be dispensed until the [Docket No. FDA–2017–D–6380]
conditions with an overall prevalence of
amozie on DSK3GDR082PROD with NOTICES1
inventories have been depleted or the Clarification of Orphan Designation of 200,000 or greater). This will help
drug products have reached their Drugs and Biologics for Pediatric resolve an unintended loophole in the
expiration dates or otherwise become Subpopulations of Common Diseases; Pediatric Research Equity Act (PREA)
violative, whichever occurs first. Guidance for Industry; Availability orphan exemption process where a
sponsor holding a pediatric-
AGENCY: Food and Drug Administration, subpopulation designation can submit a
HHS. marketing application for use of its drug
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35800/page/1.svg)
![Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35657
public. You can use an alternative instructions for submitting comments. second copy, which will have the
approach if it satisfies the requirements Comments submitted electronically, claimed confidential information
of the applicable statutes and including attachments, to https:// redacted/blacked out, will be available
regulations. This guidance is not subject www.regulations.gov will be posted to for public viewing and posted on
to Executive Order 12866. the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Dockets Management
II. Electronic Access solely responsible for ensuring that your Staff. If you do not wish your name and
Persons with access to the internet comment does not include any contact information to be made publicly
may obtain the guidance at either confidential information that you or a available, you can provide this
https://www.fda.gov/Orphan or https:// third party may not wish to be posted, information on the cover sheet and not
www.regulations.gov. such as medical information, your or in the body of your comments and you
Dated: July 23, 2018. anyone else’s Social Security number, or must identify this information as
Leslie Kux,
confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy.
that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–16027 Filed 7–26–18; 8:45 am]
information, or other information that and other applicable disclosure law. For
BILLING CODE 4164–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment
HUMAN SERVICES the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration
public, submit the comment as a Docket: For access to the docket to
[Docket No. FDA–2018–D–2478] written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Recommendations for Reducing the Submissions’’ and ‘‘Instructions’’). received, go to https://
Risk of Transfusion-Transmitted
Written/Paper Submissions www.regulations.gov and insert the
Babesiosis; Draft Guidance for
docket number, found in brackets in the
Industry; Availability Submit written/paper submissions as
heading of this document, into the
follows:
AGENCY: Food and Drug Administration, ‘‘Search’’ box and follow the prompts
• Mail/Hand Delivery/Courier (for
HHS. and/or go to the Dockets Management
written/paper submissions): Dockets
ACTION: Notice of availability. Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
Rockville, MD 20852.
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or Agency) is • For written/paper comments guidance at any time (see 21 CFR
announcing the availability of a draft submitted to the Dockets Management 10.115(g)(5)).
document entitled ‘‘Recommendations Staff, FDA will post your comment, as Submit written requests for single
for Reducing the Risk of Transfusion- well as any attachments, except for copies of the draft guidance to the Office
Transmitted Babesiosis; Draft Guidance information submitted, marked and of Communication, Outreach and
for Industry.’’ The draft guidance identified, as confidential, if submitted Development, Center for Biologics
document notifies blood establishments as detailed in ‘‘Instructions.’’ Evaluation and Research (CBER), Food
that collect blood and blood Instructions: All submissions received and Drug Administration, 10903 New
components that we have determined must include the Docket No. FDA– Hampshire Ave., Bldg. 71, Rm. 3128,
babesiosis to be a relevant transfusion- 2018–D–2478 for ‘‘Recommendations Silver Spring, MD 20993–0002. Send
transmitted infection (RTTI) and for Reducing the Risk of Transfusion- one self-addressed adhesive label to
provides recommendations for donor Transmitted Babesiosis; Draft Guidance assist the office in processing your
screening, donation testing, donor for Industry.’’ Received comments will requests. The draft guidance may also be
deferral, and product management to be placed in the docket and, except for obtained by mail by calling CBER at 1–
reduce the risk of transfusion- those submitted as ‘‘Confidential 800–835–4709 or 240–402–8010. See
transmitted babesiosis (TTB). The Submissions,’’ publicly viewable at the SUPPLEMENTARY INFORMATION section
recommendations contained in the https://www.regulations.gov or at the for electronic access to the draft
guidance apply to the collection of Dockets Management Staff between 9 guidance document.
blood and blood components, except a.m. and 4 p.m., Monday through FOR FURTHER INFORMATION CONTACT:
Source Plasma. Friday. Valerie A. Butler, Center for Biologics
DATES: Submit either electronic or • Confidential Submissions—To Evaluation and Research, Food and
written comments on the draft guidance submit a comment with confidential Drug Administration, 10903 New
by September 25, 2018 to ensure that information that you do not wish to be Hampshire Ave., Bldg. 71, Rm. 7301,
the Agency considers your comment on made publicly available, submit your Silver Spring, MD 20993–0002, 240–
this draft guidance before it begins work comments only as a written/paper 402–7911.
on the final version of the guidance. submission. You should submit two SUPPLEMENTARY INFORMATION:
ADDRESSES: You may submit comments copies total. One copy will include the
amozie on DSK3GDR082PROD with NOTICES1
information you claim to be confidential I. Background
on any guidance at any time as follows:
with a heading or cover note that states FDA is announcing the availability of
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS a draft document entitled
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The ‘‘Recommendations for Reducing the
following way: Agency will review this copy, including Risk of Transfusion-Transmitted
• Federal eRulemaking Portal: the claimed confidential information, in Babesiosis; Draft Guidance for
https://www.regulations.gov. Follow the its consideration of comments. The Industry.’’ The draft guidance document
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35800/page/3.svg)
Document Created: 2018-07-27 04:04:37
Document Modified: 2018-07-27 04:04:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on July 27, 2018. | |
| Contact | Aaron Friedman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5209, Silver Spring, MD 20993, 301-796-2989. | |
| FR Citation | 83 FR 35655 |
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