7318 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Rules and Regulations 

§ 163.1 Definitions. 

* * * * * 

(a) * * * 

(2) * * * 

(ix) The maintenance of any 

documentation that the importer may 

have in support of a claim for 

preferential tariff treatment under the 

United States-Australia Free Trade 

Agreement (AFTA), including an AFTA 

importer’s supporting statement. 

* * * * * 

■ 10. Appendix to Part 163 is amended 

by adding a listing under section IV in 

numerical order to read as follows: 

Appendix to Part 163—Interim (a)(1)(A) 

List 

* * * * * 

IV. * * * 

§ 10.723–10.727 AFTA records that the 

importer may have in support of an AFTA 

claim for preferential tariff treatment, 

including an importer’s supporting 

statement. 

* * * * * 

PART 178—APPROVAL OF 

INFORMATION COLLECTION 

REQUIREMENTS 

■ 11. The authority citation for part 178 

continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 1624; 44 

U.S.C. 3501 et seq. 

■ 12. Section 178.2 is amended by 

adding new listings for ‘‘§§ 10.723 and 

10.724’’ to the table in numerical order 

to read as follows: 

§ 178.2 Listing of OMB control numbers. 

19 CFR Section Description OMB control 

No. 

*******

§§ 10.723 and 10.724 ............................... Claim for preferential tariff treatment under the US-Australia Free Trade Agreement 1651–0117 

* * * * * * * 

* * * * * 

R. Gil Kerlikowske, 

Commissioner. 

Approved: February 5, 2015. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2015–02720 Filed 2–9–15; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 312 

[Docket No. FDA–2015–D–0268] 

Individual Patient Expanded Access 

Applications: Form FDA 3926; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of draft guidance. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Individual Patient Expanded Access 

Applications: Form FDA 3926.’’ The 

draft guidance provides for public 

comment and describes draft Form FDA 

3926 (Individual Patient Expanded 

Access—Investigational New Drug 

Application (IND)), which, when 

finalized, FDA intends to make 

available for licensed physicians to use 

for expanded access requests for 

individual patient INDs. Individual 

patient expanded access allows for the 

use of an investigational drug outside of 

a clinical trial for an individual patient 

who has a serious or immediately lifethreatening disease or condition and 

there is no comparable or satisfactory 

alternative therapy to diagnose, monitor, 

or treat the disease or condition. When 

finalized, draft Form FDA 3926 is 

intended to provide a streamlined 

alternative for submitting an 

Investigational New Drug Application 

(IND) for use in cases of individual 

patient expanded access. 

DATES: February 10, 2015. Although you 

can comment on any guidance at any 

time (see 21 CFR 10.115(g)(5)), to ensure 

that the Agency considers your 

comment on this draft guidance before 

it begins work on the final version of the 

guidance, submit either electronic or 

written comments on the draft guidance 

by April 13, 2015. Submit either 

electronic or written comments 

concerning the collection of information 

proposed in the draft guidance by April 

13, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 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, or 

to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, 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 document. 

Submit electronic comments on the 

draft guidance 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: Lori 

Bickel, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6353, Silver Spring, 

MD 20993–0002, 301–796–0210; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Individual Patient Expanded Access 

Applications: Form FDA 3926.’’ The 

draft guidance provides draft Form FDA 

3926 for public comment. When 

finalized, draft Form FDA 3926 will be 

available for licensed physicians to use 

for expanded access requests for 

individual patient INDs as an alternative 

to Form FDA 1571 (Investigation New 

Drug Application (IND)). 

On August 13, 2009, FDA published 

a final rule (74 FR 40900, August 13, 

2009) to amend its IND regulations by 

removing the certain sections of part 

312 (21 CFR part 312) on treatment use 

of investigational drugs and adding 

subpart I of part 312 on expanded access 

(part 312, subpart I). 

Subpart I describes the following 

categories of expanded access: 


rljohnson on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Rules and Regulations 7319 

• Expanded access for individual 

patients, including for emergency use; 

• Expanded access for intermediatesize patient populations (smaller than 

those typical of a treatment IND or 

treatment protocol); and 

• Expanded access through a 

treatment IND or treatment protocol 

(designed for use in larger patient 

populations). 

The final rule was, among other 

things, intended to increase awareness 

and knowledge of expanded access 

programs and the procedures for 

obtaining investigational drugs for 

treatment use for patients who have 

serious or immediately life-threatening 

diseases or conditions who lack 

therapeutic alternatives. The final rule 

was also intended to facilitate the 

availability, when appropriate, of 

investigational new drugs for treatment 

use, while protecting patient safety and 

avoiding interference with the 

development of investigational drugs for 

marketing under approved applications. 

The draft guidance is intended to 

address the submission of draft Form 

FDA 3926, when finalized, for a new 

individual patient expanded access IND 

by a licensed physician. For information 

on expanded access in general, 

including how to submit an expanded 

access protocol to an existing IND, see 

FDA’s draft guidance for industry 

‘‘Expanded Access to Investigational 

Drugs for Treatment Use—Qs and As’’ 

(available at http://www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm). 

FDA may permit expanded access to 

an investigational new drug for an 

individual patient when the applicable 

criteria in § 312.305(a), which pertains 

to all types of expanded access, and the 

criteria in § 312.310(a), which pertains 

to individual patient expanded access, 

including in an emergency, are met. The 

physician may satisfy some of the 

submission requirements by referring to 

information in an existing IND, 

ordinarily the one held by the 

manufacturer, if the physician obtains 

permission from that IND holder. If 

permission is obtained, the physician 

should then provide FDA a letter of 

authorization (LOA) from the existing 

IND holder that permits FDA to 

reference that IND. 

Section 312.305(b) sets forth the 

submission requirements for all 

expanded access uses. One of the 

requirements under § 312.305(b)(2) is 

that a ‘‘cover sheet’’ must be included 

‘‘meeting the requirements of 

§ 312.23(a).’’ This provision applies to 

several types of submissions under part 

312, ranging from commercial INDs 

under § 312.23 involving large groups of 

patients enrolled in clinical trials to 

requests from licensed physicians to use 

an investigational drug for an individual 

patient. FDA is concerned that its goal 

of facilitating access to drugs for 

individual patient treatment use may 

have been complicated by difficulties 

experienced by physicians in submitting 

Form FDA 1571 (currently used by 

sponsors for all types of IND 

submissions) including associated 

documents, which is not tailored to 

requests for individual patient 

expanded access. 

In an effort to streamline the 

submission process for individual 

patient expanded access INDs, FDA 

intends to make draft Form FDA 3926 

available, when finalized, for licensed 

physicians to request expanded access 

to an investigational drug outside of a 

clinical trial for an individual patient 

who has a serious or immediately lifethreatening disease or condition and for 

whom there is no comparable or 

satisfactory alternative therapy to 

diagnose, monitor, or treat the disease or 

condition (i.e., for individual patient 

expanded access, including in 

emergencies). Draft Form FDA 3926 is 

shorter than Form FDA 1571 and 

requests the following information: (1) 

Patient’s initials and date of submission; 

(2) clinical information; (3) treatment 

information; (4) LOA from the 

investigational drug’s manufacturer, if 

applicable; (5) physician’s 

qualifications; (6) physician’s contact 

information and the physician’s IND 

number, which is not the same as the 

manufacturer’s IND number, (if the 

number is known); (7) request for 

authorization to use draft Form FDA 

3926, when finalized, for individual 

patient expanded access applications 

instead of Form FDA 1571; and (8) 

certification statement and physician’s 

signature. Draft Form FDA 3926 is 

provided in the draft guidance for 

public comment as Appendix 1. 

As discussed in the draft guidance, 

FDA intends to accept submission of 

draft Form FDA 3926, when finalized, to 

comply with the IND submission 

requirements in §§ 312.23, 312.305(b), 

and 312.310(b). To the extent that 

information required under part 312 is 

not contained in draft Form FDA 3926, 

FDA intends to consider the submission 

of that form, when finalized, with the 

box in item 7 checked and the form 

signed by the physician, to constitute a 

request under § 312.10 to waive any 

other applicable application 

requirements, including additional 

information included in Form FDA 1571 

and Form FDA 1572 (Statement of 

Investigator, providing the identity and 

qualifications of the investigator 

conducting the clinical investigation). 

In an emergency situation that 

requires the patient to be treated before 

a written submission can be made, the 

request to use the investigational drug 

for individual patient expanded access 

may be made by telephone (or other 

rapid means of communication) to the 

appropriate FDA review division, and 

authorization of the emergency use may 

be given by the FDA official over the 

telephone, provided the physician 

explains how the expanded access use 

will meet the requirements of 

§§ 312.305 and 312.310 and agrees to 

submit an expanded access submission 

within 15 working days of FDA’s initial 

authorization of the expanded access 

use (§ 312.310(d)). 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the use of draft Form FDA 3926, 

when finalized, by licensed physicians 

for individual patient expanded access 

applications. It does not create or confer 

any rights for or on any person and does 

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. 

II. Paperwork Reduction Act of 1995 

The draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The title, 

description, and respondent description 

of the information collection are given 

under this section with an estimate of 

the annual reporting burden. Included 

in the estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

We invite 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, 


rljohnson on DSK3VPTVN1PROD with RULES
7320 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Rules and Regulations 

when appropriate, and other forms of 

information technology. 

Title: Draft Guidance on Individual 

Patient Expanded Access Applications: 

Form FDA 3926. 

Description: The draft guidance 

provides for public comment and 

describes draft Form FDA 3926. When 

finalized, draft Form FDA 3926 will be 

available for licensed physicians to 

request the use of an investigational 

drug outside of a clinical trial for an 

individual patient who has a serious or 

immediately life-threatening disease or 

condition and there is no comparable or 

satisfactory alternative therapy to 

diagnose, monitor, or treat the disease or 

condition (i.e., for individual patient 

expanded access). FDA regulations 

(§ 312.305(b)(2)) require that a cover 

sheet meeting the requirements of 

§ 312.23(a) (currently Form FDA 1571) 

be submitted for all expanded access 

requests. 

As explained in the draft guidance, 

the following information would be 

submitted to FDA by those using draft 

Form FDA 3926 when it is finalized: 

• Patient’s initials and date of 

submission. 

• Clinical information, including 

indication, brief clinical history of the 

patient (age, gender, weight, allergies, 

diagnosis, prior therapy, response to 

prior therapy), and the rationale for 

requesting the proposed treatment, 

including an explanation of why the 

patient lacks other therapeutic options. 

• Treatment information, including 

the investigational drug’s name and 

manufacturer and the treatment plan. 

The plan should include the planned 

dose, route of administration, planned 

duration of treatment, monitoring 

procedures, and planned modifications 

to the treatment plan in the event of 

toxicity. 

• LOA obtained from the 

investigational drug’s manufacturer and 

attached to draft Form FDA 3926, if 

applicable. 

• Physician’s qualification statement 

that specifies the medical school 

attended, year of graduation, medical 

specialty, state medical license number, 

current employment, and job title. 

Alternatively, the first few pages of the 

physician’s curriculum vitae may be 

attached, provided they include the 

information described previously. 

• Physician’s contact information, 

including the physical address, email 

address, telephone number, facsimile 

number, and physician’s IND number, if 

known. 

• Request for authorization to use 

Form FDA 3926, when finalized, for the 

initial submission of individual patient 

expanded access applications instead of 

Form FDA 1571. 

• Signature of the physician 

certifying that treatment will not begin 

until 30 days after FDA receives the 

application, unless the submitting 

physician receives earlier notification 

from FDA that the treatment may 

proceed; that the physician will obtain 

informed consent, consistent with 

Federal requirements; that an 

institutional review board (IRB) that 

complies with the Federal IRB 

requirements will be responsible for 

initial and continuing review and 

approval of the treatment use; and that 

in the case of an emergency request, 

treatment may begin without prior IRB 

approval, provided that the IRB is 

notified of the emergency treatment 

within 5 working days of treatment. 

Section 312.305(b)(2) of FDA’s 

expanded access regulations sets forth 

the submission requirements for all 

types of expanded access requests for 

investigational drugs. Section 

312.310(b) contains additional 

submission requirements for individual 

patient expanded access requests, and 

§ 312.310(d) contains the requirements 

for requesting individual patient 

expanded access for emergency use. 

FDA currently has OMB approval under 

control number 0910–0014 for 

individual patient expanded access 

information collection under 

§§ 312.305(b), 312.310(b), and 

312.310(d). As shown in Table 1, based 

on data for the number of these 

responses to FDA during 2011, 2012, 

and 2013, we estimate that we will 

receive approximately 593 requests 

annually for individual patient 

expanded access use from 

approximately 393 licensed physicians 

and will receive approximately 560 

requests annually for individual patient 

expanded access emergency use from 

approximately 397 licensed physicians. 

The current OMB approval also 

estimates that it takes each licensed 

physician approximately 8 hours to 

request each individual patient 

expanded access use and approximately 

16 hours to request each individual 

patient expanded access for emergency 

use. These estimates are based on the 

use of Form FDA 1571. When a 

finalized Form FDA 3926 is submitted 

instead of current Form FDA 1571, we 

estimate that the burden time will be 45 

minutes, resulting in a burden reduction 

of 7 hours and 15 minutes for each 

individual patient expanded access 

request and a burden reduction of 15 

hours and 15 minutes for each 

individual patient expanded access for 

emergency use request. That estimate is 

based on information provided by 

Department of Health and Human 

Services (DHHS) personnel who are 

familiar with preparing and reviewing 

expanded access submissions by 

practicing physicians. As shown in 

Table 1, we estimate a total of 

approximately 864.75 hours annually 

for requesting individual patient 

expanded access use and individual 

patient expanded access emergency use 

using draft Form FDA 3926, when 

finalized. This is a reduction of 

16,727.25 hours from what was 

approved under OMB control number 

0910–0014 for these submissions. 

The total estimated reporting burden 

for the draft guidance is as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

[Reduces currently approved burden of 17,592 hours under 0910–0014 by 16,727.25 hours] 1

Draft guidance on individual patient expanded 

access applications; Form FDA 3926 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(minutes) 

Total hours 

Expanded access submission for treatment of an individual patient, including submission of draft Form FDA 

3926, when finalized, instead of Form FDA 1571 ........... 790 1.46 1,153 45 864.75 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


rljohnson on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Rules and Regulations 7321 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm; or http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm; or 

http://www.regulations.gov. 

Dated: February 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02561 Filed 2–9–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 96 

[Public Notice: 9023] 

RIN 1400–AD45 

Adoptions: Regulatory Change To 

Clarify the Application of the 

Accreditation Requirement and 

Standards in Cases Covered by the 

Intercountry Adoption Universal 

Accreditation Act 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: This rule amends the 

Department of State (Department) 

interim rule on the accreditation and 

approval of adoption service providers 

in intercountry adoptions, and adopts 

the interim rule as final. The revisions 

reflect the requirement of the 

Intercountry Adoption Universal 

Accreditation Act of 2012 (UAA) that 

the accreditation standards developed 

in accordance with the 1993 Hague 

Convention on Protection of Children 

and Co-operation in Respect of 

Intercountry Adoption (Convention) and 

the Intercountry Adoption Act of 2000 

(IAA), which previously only applied in 

Convention adoption cases, apply also 

in non-Convention adoption cases. Nonconvention adoption cases are known as 

‘‘orphan’’ cases, defined in the 

Immigration and Nationality Act (INA). 

This rule also revises the accreditation 

rule by referring to the Department of 

Homeland Security (DHS) Convention 

home study regulation and deleting 

obsolete references, such as any 

reference to temporary accreditation. 

DATES: This document finalizes the 

interim final rule published on July 14, 

2014 (79 FR 40629), and is effective 

February 10, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Office of Legal Affairs, Overseas Citizen 

Services, U.S. Department of State, CA/ 

OCS/L, SA–17, Floor 10, Washington, 

DC 20522–1710; (202) 485–6079. 

SUPPLEMENTARY INFORMATION: 

Why is the Department promulgating 

this rule? 

This rule clarifies that under the 

Intercountry Adoption Universal 

Accreditation Act of 2012 (UAA), signed 

into law January 14, 2013, and effective 

July 14, 2014, the accreditation 

requirement and standards found in 22 

CFR part 96 apply to any person 

(including non-profit agencies, for-profit 

agencies and individuals but excluding 

government agencies and tribal 

authorities), providing adoption services 

on behalf of prospective adoptive 

parents in an ‘‘orphan’’ intercountry 

adoption case described under section 

101(b)(1)(F) of the Immigration and 

Nationality Act. Specifically, under 

Section 2 of the UAA ‘‘[t]he provisions 

of title II and section 404 of the 

Intercountry Adoption Act of 2000 (42 

U.S.C. 14901 et seq.), and related 

implementing regulations, shall apply to 

any person offering or providing 

adoption services in connection with a 

child described in section 101(b)(1)(F) 

of the Immigration and Nationality Act 

(8 U.S.C. 1101(b)(1)(F)), to the same 

extent as they apply to the offering or 

provision of adoption services in 

connection with a Convention 

adoption.’’ 

Title II of the Intercountry Adoption 

Act of 2000 (IAA) (Pub. L. 106–279) 

requires that any person providing 

adoption services in a Convention case 

be an accredited, approved, or an 

exempted adoption service provider, 

and section 404 imposes civil and 

criminal penalties for violations of the 

Act. On February 15, 2006 the 

Department of State published 

implementing regulations at 71 FR 8064, 

on the accreditation and approval of 

agencies and persons in accordance 

with the Convention and the IAA. 

The UAA extends that rule from 

Convention cases to ‘‘orphan’’ cases. 

This regulatory change includes a 

number of technical edits to facilitate 

interpretation of the regulatory 

requirements and clarify designated 

accrediting entities’ authority under the 

UAA and the IAA. 

The Department is amending the 

regulation to make 22 CFR part 96, as 

affected by the UAA, easier to read. This 

rule will aid the accrediting entity 

applying the standards and adoption 

service providers required to comply 

with the standards. In particular, this 

rule adds references to the UAA where 

the IAA is referenced; adds a sentence 

concerning the UAA effective date; 

redefines ‘‘Central Authority’’ to include 

competent authorities, thereby 

clarifying how the term applies in 

countries that are not party to the 

Convention; redefines adoption records 

to include non-Convention case records 

and changes Section 96.25(b) 

concerning accrediting entity access to 

non-Convention records in cases subject 

to the UAA; defines the terms INA, IAA, 

and intercountry adoption; refers to 

‘‘accreditation and approval’’ instead of 

to ‘‘Convention accreditation and 

approval;’’ revises § 96.46(a)(4) to clarify 

that foreign supervised providers in 

non-Convention countries may not have 

a pattern of licensing suspensions 

relating to key Convention principles; 

and revises references to ‘‘Convention 

adoption,’’ ‘‘cases subject to the 

Convention,’’ ‘‘Convention case,’’ 

‘‘Convention country,’’ and 

‘‘Convention-related activity’’ to ensure 

that such references include nonConvention adoptions, activities, 

countries, and cases under the UAA. 

Additionally, this rule corrects the 

references in 22 CFR 96.37(f)(2), and 

96.47(a)(4) and (b), to refer to the correct 

Department of Homeland Security 

(DHS) definition of home study preparer 

and home study requirements. When 

the original rule was issued in 2006, 

DHS had not yet published its final rule 

concerning home studies in Convention 

cases. Thus, the 2006 State Department 

rule referred to the ‘‘orphan’’ home 

study requirements under 8 CFR 

204.3(b) and (e), instead of the 

Convention home study requirements 

found in 8 CFR 204.301 and 311. This 

rule references the correct DHS 

regulation. The change clarifies that the 

home study must be prepared by an 

accredited agency, approved person, 

exempted provider, or a supervised 

provider. In addition, when the home 

study is not performed in the first 

instance by an accredited agency, then 

an accredited agency must review and 

approve it. The orphan and Convention 

home study requirements also differ 

concerning the required elements, 


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