80_FR_12547 80 FR 12502 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

80 FR 12502 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 45 (March 9, 2015)

Page Range12502-12504
FR Document2015-05347

The Food and Drug Administration (FDA or the Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

Federal Register, Volume 80 Issue 45 (Monday, March 9, 2015) 
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12502-12504]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Product-Specific Bioequivalence Recommendations; Draft and 
Revised Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of additional draft and revised draft 
product-specific bioequivalence (BE) recommendations. The 
recommendations provide product-specific guidance on the design of BE 
studies to support abbreviated new drug applications (ANDAs). In the 
Federal Register of June 11, 2010, FDA announced the availability of a 
guidance for industry entitled ``Bioequivalence Recommendations for 
Specific Products,'' which explained the process that would be used to 
make product-specific BE recommendations available to the public on 
FDA's Web site. The BE recommendations identified in this notice were 
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR

[[Page 12503]]

10.115(g)(5)), to ensure that the Agency considers your comments on 
these draft and revised draft guidances before it begins work on the 
final versions of the guidances, submit either electronic or written 
comments on the draft and revised draft product-specific BE 
recommendations listed in this notice by May 8, 2015.

ADDRESSES: Submit written requests for single copies of the individual 
BE guidances to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE 
recommendations to http://www.regulations.gov. Submit written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products,'' which 
explained the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means 
to develop and disseminate product-specific BE recommendations and 
provide a meaningful opportunity for the public to consider and comment 
on those recommendations. Under that process, draft recommendations are 
posted on FDA's Web site and announced periodically in the Federal 
Register. The public is encouraged to submit comments on those 
recommendations within 60 days of their announcement in the Federal 
Register. FDA considers any comments received, and either publishes 
final recommendations or publishes revised draft recommendations for 
comment. Recommendations were last announced in the Federal Register on 
December 30, 2014 (79 FR 78447). This notice announces draft product-
specific recommendations, either new or revised, that are posted on 
FDA's Web site.

II. Drug Products for Which New Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing the availability of a new draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A..............................  Avanafil.
                                 Azilsartan medoxomil; Chlorthalidone.
B..............................  Buprenorphine hydrochloride; Naloxone
                                  hydrochloride.
C..............................  Chlorpheniramine maleate; Ibuprofen;
                                  Phenylephrine hydrochloride.
                                 Cyclosporine (multiple reference listed
                                  drugs).
D..............................  Deferiprone.
                                 Desoximetasone.
                                 Diclofenac.
                                 Dorzolamide.
                                 Doxepin hydrochloride.
E..............................  Eltrombopag olamine.
                                 Emtricitabine; Rilpivirine
                                  hydrochloride; Tenofovir disoproxil
                                  fumarate.
F..............................  Flucinolone acetonide; Hydroquinone;
                                  Tretinoin.
I..............................  Ibrutinib.
                                 Ibuprofen.
                                 Ipratropium bromide.
                                 Isosorbide dinitrate.
                                 Isotretinoin.
                                 Ivacaftor.
L..............................  Loperamide hydrochloride (multiple
                                  reference listed drugs and dosage
                                  forms).
M..............................  Minocycline hydrochloride.
N..............................  Naproxen sodium; Diphenhydramine
                                  hydrochloride.
O..............................  Oseltamivir phosphate.
                                 Oxybutynin chloride.
P..............................  Potassium chloride.
                                 Praziquantel.
                                 Pyrimethamine.
S..............................  Sodium polystyrene sulfonate
                                 Spinosad.
                                 Sucroferric oxyhydroxide.
T..............................  Ticagrelor.
                                 Topiramate (multiple reference listed
                                  drugs).
V..............................  Vigabatrin.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing the availability of a revised draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------
 
------------------------------------------------------------------------
B..............................  Brimonidine tartrate (multiple
                                  reference listed drugs).
                                 Brimonidine tartrate; Brinzolamide.
                                 Brinzolamide.
                                 Budesonide.
C..............................  Carbamazepine (multiple reference
                                  listed drugs and dosage forms).
                                 Ciprofloxacin; dexamethasone.
D..............................  Dexmethylphenidate hydrochloride.
                                 Dextroamphetamine sulfate.
                                 Doxepin hydrochloride.
G..............................  Gabapentin.
I..............................  Isotretinoin.
M..............................  Methylphenidate hydrochloride.
                                 Mirtazapine.
N..............................  Nisoldipine.
P..............................  Paliperidone.
T..............................  Teriflunomide.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). These 
guidances represent the Agency's current thinking on product-specific 
design of BE studies to support ANDAs. They do not create or confer any 
rights for or on any person and do not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit either electronic comments on any of 
the specific BE recommendations posted on FDA's Web site to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. The guidances, notices, and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and

[[Page 12504]]

will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05347 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P

12502 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices FDA has actively participated in the published in the Federal Register of V. Comments International Conference on September 15, 2011 (76 FR 57056). The Interested persons may submit either Harmonisation of Technical revised guidance includes minor electronic comments regarding this Requirements for Registration of changes that clarify recommendations document to www.regulations.gov or Pharmaceuticals for Human Use for for conducting a single timepoint study written comments to the Division of several years to develop harmonized for products proposed for a 0-day Dockets Management (see ADDRESSES). It technical requirements for the approval withdrawal period or a 0-day milk is only necessary to send one set of of human pharmaceutical and biological discard time. In addition, the design for comments. Identify comments with the products among the European Union, a 0-day milk discard timestudy was docket number found in brackets in the Japan, and the United States. The VICH described, and a definition for heading of this document. Received is a parallel initiative for veterinary preruminant was added. This revised comments may be seen in the Division medicinal products. The VICH is guidance is a product of the Metabolism of Dockets Management between 9 a.m. concerned with developing harmonized and Residue Kinetics Expert Working and 4 p.m., Monday through Friday, and technical requirements for the approval Group of the VICH. will be posted to the docket at http:// of veterinary medicinal products in the As part of the approval process for www.regulations.gov. European Union, Japan, and the United veterinary medicinal products in food- States, and includes input from both producing animals, national/regional VI. Electronic Access regulatory and industry representatives. regulatory authorities require data from Persons with access to the Internet The VICH Steering Committee is marker residue depletion studies in may obtain the guidance at either composed of member representatives order to establish appropriate http://www.fda.gov/AnimalVeterinary/ from the European Commission, withdrawal periods in edible tissues, GuidanceComplianceEnforcement/ European Medicines Evaluation Agency, including meat, milk, and eggs. The GuidanceforIndustry/default.htm or European Federation of Animal Health, objective of this guidance is to provide http://www.regulations.gov. Committee on Veterinary Medicinal study design recommendations that will Products, FDA, U.S. Department of Dated: March 3, 2015. facilitate the universal acceptance of the Agriculture, the Animal Health Leslie Kux, generated residue depletion data to Institute, Japanese Veterinary fulfill the national/regional Associate Commissioner for Policy. Pharmaceutical Association, Japanese requirements. [FR Doc. 2015–05345 Filed 3–6–15; 8:45 am] Association of Veterinary Biologics, and BILLING CODE 4164–01–P Japanese Ministry of Agriculture, III. Significance of Guidance Forestry, and Fisheries. As a result of Level 2 revisions, this Six observers are eligible to DEPARTMENT OF HEALTH AND participate in the VICH Steering VICH revised guidance is being issued in final, consistent with FDA’s good HUMAN SERVICES Committee: One representative from the government of Australia/New Zealand, guidance practice (GGP) regulations at Food and Drug Administration one representative from the industry in 21 CFR 10.115(g)(4). This guidance, developed under the VICH process, has [Docket No. FDA–2007–D–0369] Australia/New Zealand, one representative from the government of been revised to conform to FDA’s GGP regulation (21 CFR 10.115). For Product-Specific Bioequivalence Canada, one representative from the Recommendations; Draft and Revised industry of Canada, one representative example, the document has been designated ‘‘guidance’’ rather than Draft Guidances for Industry; from the government of South Africa, Availability and one representative from the ‘‘guideline.’’ In addition, guidance industry of South Africa. The VICH documents must not include mandatory AGENCY: Food and Drug Administration, Secretariat, which coordinates the language such as ‘‘shall,’’ ‘‘must,’’ HHS. preparation of documentation, is ‘‘require,’’ or ‘‘requirement,’’ unless ACTION: Notice. provided by the International FDA is using these words to describe a Federation for Animal Health (IFAH). statutory or regulatory requirement. SUMMARY: The Food and Drug An IFAH representative also This VICH guidance represents the Administration (FDA or the Agency) is participates in the VICH Steering Agency’s current thinking on this topic. announcing the availability of Committee meetings. It does not create or confer any rights for additional draft and revised draft or on any person and does not operate product-specific bioequivalence (BE) II. Revised Guidance on Studies To to bind FDA or the public. An recommendations. The Evaluate the Metabolism and Residue alternative approach may be used if recommendations provide product- Kinetics of Veterinary Drugs in Food- such approach satisfies the specific guidance on the design of BE Producing Animals: Marker Residue requirements of applicable statutes and studies to support abbreviated new drug Depletion Studies To Establish Product regulations. applications (ANDAs). In the Federal Withdrawal Periods Register of June 11, 2010, FDA IV. Paperwork Reduction Act of 1995 announced the availability of a guidance In June 2014, the VICH Steering Committee agreed that a revised This revised guidance refers to for industry entitled ‘‘Bioequivalence guidance document entitled ‘‘Studies to previously approved collections of Recommendations for Specific Evaluate the Metabolism and Residue information found in FDA regulations. Products,’’ which explained the process that would be used to make product- mstockstill on DSK4VPTVN1PROD with NOTICES Kinetics of Veterinary Drugs in Food- These collections of information are Producing Animals: Marker Residue subject to review by the Office of specific BE recommendations available Depletion Studies to Establish Product Management and Budget (OMB) under to the public on FDA’s Web site. The BE Withdrawal Periods’’ (VICH GL48(R)) the Paperwork Reduction Act of 1995 recommendations identified in this should be made available to the public. (44 U.S.C. 3501–3520). The collections notice were developed using the process The revised guidance is a revision of a of information in 21 CFR part 514 have described in that guidance. final guidance on the same topic for been approved under OMB control DATES: Although you can comment on which a notice of availability was number 0910–0032. any guidance at any time (see 21 CFR VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12503 10.115(g)(5)), to ensure that the Agency received, and either publishes final III. Drug Products for Which Revised considers your comments on these draft recommendations or publishes revised Draft Product-Specific BE and revised draft guidances before it draft recommendations for comment. Recommendations Are Available begins work on the final versions of the Recommendations were last announced FDA is announcing the availability of guidances, submit either electronic or in the Federal Register on December 30, a revised draft guidance for industry on written comments on the draft and 2014 (79 FR 78447). This notice product-specific BE recommendations revised draft product-specific BE announces draft product-specific for drug products containing the recommendations listed in this notice recommendations, either new or following active ingredients: by May 8, 2015. revised, that are posted on FDA’s Web ADDRESSES: Submit written requests for site. TABLE 2—REVISED DRAFT PRODUCT- single copies of the individual BE II. Drug Products for Which New Draft SPECIFIC BE RECOMMENDATIONS guidances to the Division of Drug Product-Specific BE Recommendations FOR DRUG PRODUCTS Information, Center for Drug Evaluation and Research, Food and Drug Are Available B ..... Brimonidine tartrate (multiple ref- Administration, 10001 New Hampshire erence listed drugs). Ave., Hillandale Building, 4th Floor, FDA is announcing the availability of a new draft guidance for industry on Brimonidine tartrate; Brinzolamide. Silver Spring, MD 20993–0002. Send Brinzolamide. one self-addressed adhesive label to product-specific BE recommendations Budesonide. assist that office in processing your for drug products containing the C ..... Carbamazepine (multiple reference requests. See the SUPPLEMENTARY following active ingredients: listed drugs and dosage forms). INFORMATION section for electronic Ciprofloxacin; dexamethasone. access to the draft guidance TABLE 1—NEW DRAFT PRODUCT-SPE- D ..... Dexmethylphenidate hydrochloride. recommendations. CIFIC BE RECOMMENDATIONS FOR Dextroamphetamine sulfate. Doxepin hydrochloride. Submit electronic comments on the DRUG PRODUCTS G ..... Gabapentin. draft product-specific BE I ....... Isotretinoin. recommendations to http:// A ..... Avanafil. M ..... Methylphenidate hydrochloride. www.regulations.gov. Submit written Azilsartan medoxomil; Chlorthalidone. Mirtazapine. comments to the Division of Dockets B ..... Buprenorphine hydrochloride; N ..... Nisoldipine. Management (HFA–305), Food and Drug Naloxone hydrochloride. P ..... Paliperidone. Administration, 5630 Fishers Lane, Rm. C ..... Chlorpheniramine maleate; Ibuprofen; T ..... Teriflunomide. 1061, Rockville, MD 20852. Phenylephrine hydrochloride. FOR FURTHER INFORMATION CONTACT: Cyclosporine (multiple reference listed For a complete history of previously Xiaoqiu Tang, Center for Drug drugs). published Federal Register notices D ..... Deferiprone. related to product-specific BE Evaluation and Research, Food and Desoximetasone. recommendations, go to http:// Drug Administration, 10903 New Diclofenac. www.regulations.gov and enter Docket Hampshire Ave., Bldg. 75, Rm. 4730, Dorzolamide. No. FDA–2007–D–0369. Silver Spring, MD 20993–0002, 301– Doxepin hydrochloride. These draft and revised draft 796–5850. E ..... Eltrombopag olamine. SUPPLEMENTARY INFORMATION: guidances are being issued consistent Emtricitabine; Rilpivirine hydro- with FDA’s good guidance practices I. Background chloride; Tenofovir disoproxil fuma- rate. regulation (21 CFR 10.115). These In the Federal Register of June 11, F ..... Flucinolone acetonide; Hydroquinone; guidances represent the Agency’s 2010 (75 FR 33311), FDA announced the Tretinoin. current thinking on product-specific availability of a guidance for industry I ....... Ibrutinib. design of BE studies to support ANDAs. entitled ‘‘Bioequivalence Ibuprofen. They do not create or confer any rights Recommendations for Specific Ipratropium bromide. for or on any person and do not operate Products,’’ which explained the process Isosorbide dinitrate. to bind FDA or the public. An that would be used to make product- Isotretinoin. alternative approach may be used if specific BE recommendations available Ivacaftor. such approach satisfies the to the public on FDA’s Web site at L ...... Loperamide hydrochloride (multiple requirements of the applicable statutes http://www.fda.gov/Drugs/Guidance reference listed drugs and dosage and regulations. ComplianceRegulatoryInformation/ forms). M ..... Minocycline hydrochloride. IV. Comments Guidances/default.htm. As described in that guidance, FDA N ..... Naproxen sodium; Diphenhydramine Interested persons may submit either adopted this process as a means to hydrochloride. electronic comments on any of the develop and disseminate product- O ..... Oseltamivir phosphate. specific BE recommendations posted on specific BE recommendations and Oxybutynin chloride. FDA’s Web site to http:// provide a meaningful opportunity for P ..... Potassium chloride. www.regulations.gov or written the public to consider and comment on Praziquantel. comments to the Division of Dockets those recommendations. Under that Pyrimethamine. Management (see ADDRESSES). It is only S ..... Sodium polystyrene sulfonate mstockstill on DSK4VPTVN1PROD with NOTICES process, draft recommendations are necessary to send one set of comments. Spinosad. Identify comments with the docket posted on FDA’s Web site and Sucroferric oxyhydroxide. number found in brackets in the announced periodically in the Federal T ..... Ticagrelor. Register. The public is encouraged to heading of this document. The Topiramate (multiple reference listed submit comments on those guidances, notices, and received drugs). recommendations within 60 days of V ..... Vigabatrin. comments may be seen in the Division their announcement in the Federal of Dockets Management between 9 a.m. Register. FDA considers any comments and 4 p.m., Monday through Friday, and VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

12504 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices will be posted to the docket at http:// Instructions: All submissions received nationwide. In addition, the DQSA adds www.regulations.gov. must include the Agency name and a new section, 503B, to the FD&C Act Docket No. [FDA–2015–N–0030]. All (21 U.S.C. 353b) that creates a new V. Electronic Access comments received may be posted category of ‘‘outsourcing facilities’’. Persons with access to the Internet without change to http:// Outsourcing facilities, as defined in may obtain the document at either www.regulations.gov, including any section 503B of the FD&C Act, are http://www.fda.gov/Drugs/Guidance personal information provided. facilities that meet certain conditions ComplianceRegulatoryInformation/ Docket: For access to the docket to described in section 503B, including Guidances/default.htm or http:// read background documents or registration with FDA as an outsourcing www.regulations.gov. comments received, go to http:// facility. If these conditions are satisfied, Dated: March 3, 2015. www.regulations.gov and insert the a drug compounded for human use by docket number found in brackets in the or under the direct supervision of a Leslie Kux, heading of this document, into the licensed pharmacist in an outsourcing Associate Commissioner for Policy. ‘‘Search’’ box and follow the prompts facility is exempt from three sections of [FR Doc. 2015–05347 Filed 3–6–15; 8:45 am] and/or go to the Division of Dockets the FD&C Act: (1) Section 502(f)(1), (2) BILLING CODE 4164–01–P Management (HFA–305), Food and Drug section 505, and (3) section 582 (21 Administration, 5630 Fishers Lane, Rm. U.S.C. 360eee), but not section 1061, Rockville, MD 20852. 501(a)(2)(B). DEPARTMENT OF HEALTH AND Since enactment of the DQSA, FDA FOR FURTHER INFORMATION CONTACT: HUMAN SERVICES Philantha Bowen, Center for Drug has sought public comment on a Evaluation and Research, Food and number of specific human drug Food and Drug Administration Drug Administration, 10903 New compounding issues and has published [Docket No. FDA–2015–N–0030] Hampshire Ave., Bldg.51, Rm. 5175, several Federal Register notices seeking Silver Spring, MD 20993–0002, 301– public input. These have included Compounding of Human Drug 796–2466. notices inviting comment on the Products Under the Federal Food, registration process and product SUPPLEMENTARY INFORMATION: Drug, and Cosmetic Act; reporting requirements for human drug Establishment of a Public Docket I. Background compounding outsourcing facilities (78 AGENCY: Food and Drug Administration, Section 503A of the FD&C Act (21 FR 72899 and 78 FR 72897), requesting HHS. U.S.C. 353a) describes the conditions nominations for the list of drugs that that must be satisfied for human drug present demonstrable difficulties for ACTION: Notice; establishment of public products compounded by a licensed compounding (78 FR 72840), and docket. pharmacist or licensed physician to be seeking input on other specific matters. SUMMARY: The Food and Drug exempt from the following three A complete list of the human drug Administration (FDA or Agency) is sections of the FD&C Act: (1) Section compounding policy documents issued establishing a public docket to receive 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) by the Agency for public comment can information, recommendations, and (concerning current good manufacturing be found at http://www.fda.gov/Drugs/ comments on matters related to the practice); (2) section 502(f)(1) (21 U.S.C. GuidanceCompliance 352(f)(1)) (concerning the labeling of RegulatoryInformation/Pharmacy Agency’s regulation of compounding of drugs with adequate directions for use); Compounding/ucm166743.htm. The human drug products under sections and (3) section 505 (21 U.S.C. 355) Agency will continue to seek public 503A and 503B of the Federal Food, (concerning the approval of drugs under comment on specific documents and Drug, and Cosmetic Act (FD&C Act). new drug applications or abbreviated issues through future Federal Register This docket is intended for general new drug applications). Previously, the notices. The Agency recognizes, comments related to human drug conditions of section 503A of the FD&C however, that it would be useful to have compounding that are not specific to Act also included restrictions on the a docket available for submissions of documents or issues that are the subject advertising or promotion of the any information related to human drug of other dockets. compounding of any particular drug, compounding that may be unrelated to DATES: Comments may be submitted to class of drug, or type of drug and the the specific issues and documents this docket at any time. solicitation of prescriptions for published for public comment. ADDRESSES: You may submit comments, compounded drugs. These provisions identified by Docket No. [FDA–2015–N– II. Establishment of a Docket were challenged in court and held 0030], by any of the following methods. unconstitutional by the U.S. Supreme FDA is establishing a public docket so Court in 2002.1 that anyone can share information, Electronic Submissions research, and ideas on any matters On November 27, 2013, President Submit electronic comments in the Obama signed the Drug Quality and related to human drug compounding following way: Security Act (DQSA) (Pub. L. 113–54), that are not specific to the documents or • Federal eRulemaking Portal: http:// which contains important provisions issues addressed in other dockets. This www.regulations.gov. Follow the relating to the oversight of human drug information will give the Agency insight instructions for submitting comments. compounding. This new law removes into stakeholders’ experiences and from section 503A of the FD&C Act the views regarding human drug Written Submissions mstockstill on DSK4VPTVN1PROD with NOTICES provisions that had been held compounding as the Agency works to Submit written comments in the unconstitutional by the U.S. Supreme implement sections 503A and 503B of following ways: Court in 2002. By removing these the FD&C Act. • Mail/Hand delivery/Courier (for provisions, the new law clarifies that This docket will be open for comment paper submissions): Division of Dockets section 503A of the FD&C Act applies simultaneously with a number of other Management (HFA–305), Food and Drug dockets that are specific to particular Administration, 5630 Fishers Lane, Rm. 1 See Thompson v. Western States Med. Ctr., 535 human drug compounding documents 1061, Rockville, MD 20852. U.S. 357 (2002). or issues (see http://www.fda.gov/drugs/ VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1


Document Created: 2015-12-18 12:05:12
Document Modified: 2015-12-18 12:05:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by May 8, 2015.
ContactXiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850.
FR Citation80 FR 12502 
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