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request. Written requests are to be sentto the Division of Freedom ofInformation (ELEM1029), Food andDrug Administration, 12420 ParklawnDr., Element Bldg., Rockville, MD20857.

Dated: May 3, 2013.

Peter Lurie,

Acting Associate Commissioner for Policy andPlanning.

[FR Doc. 201311007 Filed 5813; 8:45 am]

BILLING CODE 416001P

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. FDA2013D0446]

Draft Guidance for Industry onExpanded Access to InvestigationalDrugs for Treatment UseQuestionsand Answers; Availability

AGENCY: Food and Drug Administration,HHS.

ACTION: Notice of availability.

SUMMARY: The Food and DrugAdministration (FDA) is announcing theavailability of a draft guidance forindustry entitled Expanded Access toInvestigational Drugs for TreatmentUseQs & As. This guidance isintended to provide information forindustry, researchers, physicians, andpatients about certain aspects of FDAsimplementation of its regulations onexpanded access to investigationaldrugs for treatment use. FDA hasreceived a number of questions aboutimplementation of its expanded accessregulations. Therefore, FDA is providingthis draft guidance in a question andanswer format, addressing the mostfrequently asked questions.

DATES: Although you can comment onany guidance at any time (see 21 CFR10.115(g)(5)), to ensure that the Agencyconsiders your comment on this draftguidance before it begins work on thefinal version of the guidance, submiteither electronic or written commentson the draft guidance by July 8, 2013.

ADDRESSES: Submit written requests forsingle copies of the draft guidance to theDivision of Drug Information, Center forDrug Evaluation and Research, Foodand Drug Administration, 10903 NewHampshire Ave., Bldg. 51, rm. 2201,Silver Spring, MD 209930002 or Officeof Communication, Outreach, andDevelopment (HFM40), Center forBiologics Evaluation and Research,Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,MD 208521448. Send one self-addressed adhesive label to assist thatoffice in processing your requests. Seethe SUPPLEMENTARY INFORMATION sectionfor electronic access to the draftguidance document.

Submit electronic comments on thedraft guidance to http://

www.regulations.gov.Submit writtencomments to the Division of DocketsManagement (HFA305), Food and DrugAdministration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Forthe Center for Drug Evaluation andResearch:Colleen L. Locicero, Centerfor Drug Evaluation and Research, Foodand Drug Administration, 10903 NewHampshire Ave., Bldg. 22, rm. 4200,Silver Spring, MD 209930002, 3017962270.

For the Center for BiologicsEvaluation and Research:Stephen M.

Ripley, Center for Biologics Evaluationand Research (HFM17), Food and DrugAdministration, 1401 Rockville Pike,Rockville, MD 208521448, 3018276210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability ofa draft guidance for industry entitledExpanded Access to InvestigationalDrugs for Treatment UseQs & As.FDAs expanded access regulations (21CFR part 312, subpart I) went into effecton October 13, 2009 (74 FR 40900).

These regulations contain therequirements for the use ofinvestigational new drugs or approveddrugs where availability is limited by arisk evaluation and mitigation strategy(REMS), when the primary purpose is todiagnose, monitor, or treat a patientsdisease or condition. Under theseregulations, there are three categories ofexpanded access based on the size of thepatient population to be treated: (1)Individual patient access, including foremergency use; (2) intermediate-sizepatient population access; and (3) largerpopulation access under a treatment

protocol or treatment investigationalnew drug application (IND). Theseregulations are intended to facilitate theavailability of investigational newdrugs, or approved drugs whereavailability is limited by a REMS, topatients with serious or immediatelylife-threatening diseases or conditionswho lack other therapeutic options andmay benefit from investigationaltherapies.

Elsewhere in this issue of the FederalRegister, FDA is announcing theavailability of the draft guidance

entitled Charging for InvestigationalDrugs Under an INDQs & As, whichis intended to provide informationabout FDAs implementation of itsregulation on charging forinvestigational drugs under aninvestigational new drug applications,including investigational drugs madeavailable under expanded access

programs.One of FDAs major goals in

promulgating these expanded accessregulations was to make expandedaccess a more transparent process byincreasing awareness and knowledge ofexpanded access programs and theprocedures for obtaining investigationaldrugs for treatment use. Since theseexpanded access regulations went intoeffect in 2009, FDA has received anumber of questions concerning itsimplementation of the regulations.Consistent with the goal of makingexpanded access processes more

transparent, FDA is providing this draftguidance to address frequently askedquestions about how it is interpretingvarious provisions in the expandedaccess regulations, including questionsabout when it is appropriate to requestaccess under each of the three accesscategories, the types and content ofaccess submissions, IRB review ofindividual patient expanded access, andthe onset and duration of access use.

Although FDA is inviting comment onthe entire draft guidance (21 CFR10.115(g)(1)(ii)(C)), FDA notes that it isparticularly interested in receivingcomments on question 10. Question 10

asks, Is Institutional Review Board(IRB) review and approval required forindividual patient expanded access? Inthe draft guidance, FDA explains thatunder current regulations for allexpanded access uses, includingindividual patient access uses,investigators are required to ensure thatIRB review and approval is obtainedconsistent with 21 CFR part 56 (21 CFR312.305(c)(4)). 21 CFR part 56 requires,among other things, that an IRB reviewthe expanded access use at a convenedmeeting at which a majority of the IRBmembers are present (full IRB review)

(21 CFR 56.108(c)). However, FDA isaware of concerns that this requirementfor full IRB review may deter individualpatient access to investigational drugsfor treatment use. FDA has encourageduse of central IRBs for review ofexpanded access uses to address theseconcerns. However, other options may

be needed. Therefore, FDA isparticularly interested in receivingcomments on this issue, including towhat extent the requirement for full IRBreview of individual patient expandedaccess is a deterrent to patient access,

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whether FDA should consideralternatives to full IRB review ofindividual patient expanded access, andwhat alternative approaches may betterfacilitate access while providingappropriate ethical oversight.

This draft guidance is being issuedconsistent with FDAs good guidancepractices regulation (21 CFR 10.115).The draft guidance, when finalized, willrepresent the Agencys current thinkingon expanded access to investigationaldrugs for treatment use. It does notcreate or confer any rights for or on anyperson and does not operate to bindFDA or the public. An alternativeapproach may be used if such approachsatisfies the requirements of theapplicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This draft guidance refers topreviously approved collections ofinformation found in FDA regulations.

These collections of information aresubject to review by the Office ofManagement and Budget (OMB) underthe Paperwork Reduction Act of 1995(44 U.S.C. 35013520). The collectionsof information in 312.305, 312.310,312.315, and 312.320 have beenapproved under OMB control number09100014.

III. Comments

Interested persons may submit eitherelectronic comments regarding thisdocument to http://www.regulations.govor written comments to the Division of

Dockets Management (see ADDRESSES). Itis only necessary to send one set ofcomments. Identify comments with thedocket number found in brackets in theheading of this document. Receivedcomments may be seen in the Divisionof Dockets Management between 9 a.m.and 4 p.m., Monday through Friday, andwill be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internetmay obtain the document at eitherhttp://www.fda.gov/Drugs/

GuidanceComplianceRegulatoryInformation/Guidances/default.htm,http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/defaultor http://www.regulations.gov.

Dated: May 3, 2013.

Peter Lurie,

Acting Associate Commissioner for Policy andPlanning.

[FR Doc. 201311005 Filed 5813; 8:45 am]

BILLING CODE 416001P

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. FDA2013D0447]

Draft Guidance for Industry onCharging for Investigational DrugsUnder an Investigational New DrugApplicationQuestions and Answers;Availability

AGENCY: Food and Drug Administration,HHS.

ACTION: Notice of availability.

SUMMARY: The Food and DrugAdministration (FDA) is announcing theavailability of a draft guidance forindustry entitled Charging forInvestigational Drugs Under an INDQs& As. This guidance is intended to

provide information for industry,researchers, and physicians on howFDA is implementing its regulation oncharging for an investigational drugunder an investigational new drug (IND)application. FDA has received a numberof questions about how it isimplementing the charging regulation.Therefore, FDA is providing this draftguidance in a question and answerformat, addressing the most frequentlyasked questions and answers, includingquestions about charging forinvestigational drugs made availableunder expanded access programs.

DATES

: Although you can comment onany guidance at any time (see 21 CFR10.115(g)(5)), to ensure that the Agencyconsiders your comment on this draftguidance before it begins work on thefinal version of the guidance, submiteither electronic or written commentson the draft guidance by July 8, 2013.

ADDRESSES: Submit written requests forsingle copies of the draft guidance to theDivision of Drug Information, Center forDrug Evaluation and Research, Foodand Drug Administration, 10903 NewHampshire Ave., Bldg. 51, rm. 2201,Silver Spring, MD 209930002; or Office

of Communication, Outreach, andDevelopment (HFM40), Center forBiologics Evaluation and Research,Food and Drug Administration, 1401Rockville Pike, suite 200N, Rockville,MD 208521448. Send one self-addressed adhesive label to assist thatoffice in processing your requests. Seethe SUPPLEMENTARY INFORMATION sectionfor electronic access to the draftguidance document.

Submit electronic comments on thedraft guidance to http://www.regulations.gov.Submit written

comments to the Division of DocketsManagement (HFA305), Food and DrugAdministration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:For the Center for Drug Evaluation

and Research:

Colleen L. Locicero, Center for Drug

Evaluation and Research, Food andDrug Administration, 10903 NewHampshire Ave., Bldg. 22, rm. 4200,Silver Spring, MD 209930002, 3017962270.

For the Center for BiologicsEvaluation and Research:

Stephen M. Ripley, Center for BiologicsEvaluation and Research (HFM17),Food and Drug Administration, 1401Rockville Pike, Rockville, MD 208521448, 3018276210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability ofa draft guidance for industry entitledCharging for Investigational DrugsUnder an INDQs & As. In 2009, FDAamended its regulation concerningcharging for investigational new drugsunder an IND (August 13, 2009; 74 FR40872). The new regulation, which wentinto effect on October 13, 2009, removedparagraph (d) of 312.7 (21 CFR 312.7)and replaced it with new 312.8. Thenew regulation is intended to clarify thecircumstances in which charging for aninvestigational drug in a clinical trial isappropriate, to set forth criteria for

charging for an investigational drug forthe three types of expanded access fortreatment use described in subpart I of21 CFR part 312, and to clarify whatcosts can be recovered for aninvestigational drug. Elsewhere in thisissue of the Federal Register, FDA isannouncing the availability of the draftguidance entitled Expanded Access toInvestigational Drugs for TreatmentUseQs & As, which is intended toprovide information about FDAsimplementation of its expanded accessregulations (21 CFR part 312, subpart I).

Since 312.8 has been in effect, FDAhas received numerous questions abouthow it is implementing the regulationand interpreting various provisions.Consistent with the goal of clarifying therequirements for charging for aninvestigational drug and the types ofcosts that can be recovered, FDA isproviding a draft guidance in a questionand answer format, addressing the mostfrequently asked questions and answersabout charging for investigational drugunder an IND.

This draft guidance is being issuedconsistent with FDAs good guidance

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