Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69857 

good manufacturing practice for drugs). 

This guidance describes in detail the fee 

types and amounts an entity must pay 

to satisfy the fee requirements of 

sections 503B and 744K of the FD&C 

Act to be deemed an outsourcing facility 

and maintain its status as an 

outsourcing facility, the adjustments to 

the fees required by law, how to qualify 

as a small business to obtain a reduction 

of the annual establishment fee, how 

and when to submit payment to FDA, 

the effect of failure to pay fees, and feerelated dispute resolution. 

On April 1, 2014 (79 FR 18297), FDA 

announced the availability of the draft 

version of this guidance. The public 

comment period closed on June 2, 2014. 

One comment was received from the 

public, and FDA carefully considered 

that comment as it finalized the 

guidance. Some of the issues raised 

relate to matters that FDA intends to 

address in other policy documents and 

were not directly pertinent to the topics 

addressed in this guidance. During 

finalization of the guidance, FDA made 

both clarifying changes and minor 

editorial changes to the guidance and 

accompanying form. For example, FDA 

clarified that it intends to issue an 

invoice for reinspection fees within 14 

calendar days of the close of the 

reinspection, and that the reinspection 

fee must be paid within 30 calendar 

days of the date of the invoice. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on fees associated with human 

drug compounding outsourcing 

facilities. 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. Comments 

Interested persons can 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 can 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. 

III. Paperwork Reduction Act of 1995 

This guidance contains collections of 

information that are subject to review by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3520). The 

collections of information have been 

approved under OMB control number 

0910–0776. 

IV. Electronic Access 

Persons with access to the Internet 

can obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27692 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1428] 

Electronic Product Reporting for 

Human Drug Compounding 

Outsourcing Facilities; Draft Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a revised 

draft guidance entitled ‘‘Electronic 

Product Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ The 

revised draft guidance addresses 

provisions in the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) added 

by the Drug Quality and Security Act 

(DQSA) and updates reporting 

instructions for drug compounders that 

choose to register as outsourcing 

facilities. Such compounders must 

report information on the drugs they 

have compounded in Structured 

Product Labeling (SPL) format using 

FDA’s electronic submissions system. 

This revised draft guidance supersedes 

a draft guidance entitled ‘‘Interim 

Product Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ 

DATES: Although 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 this 

revised draft guidance, submit either 

electronic or written comments on the 

revised draft guidance by January 23, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the revised draft guidance by January 

23, 2015. 

ADDRESSES: Submit written requests for 

single copies of the revised draft 

guidance document 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 request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the revised draft guidance. 

Submit electronic comments on the 

revised 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: 

Lysette Deshields, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Electronic Product Reporting 

for Human Drug Compounding 

Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act.’’ In the Federal Register 

of December 4, 2013 (78 FR 72897), FDA 

issued a notice announcing the 

availability of an initial draft of this 

guidance entitled ‘‘Interim Product 

Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ That 

draft guidance addressed new 

provisions in the FD&C Act added by 

the DQSA and set forth an interim 

submission method for human drug 

compounders that choose to register as 

outsourcing facilities. 

The comment period on the initial 

draft guidance ended on February 3, 

2014. FDA received six comments on 

the draft. In response to received 

comments or on its own initiative, FDA 

made the following changes and 

updates in the revised draft guidance: 

(1) Modified the scope of the guidance 

to refer to product reports submitted in 

SPL format; (2) clarified the following 

elements required in a product report: 

‘‘Strength of the active ingredient per 

unit,’’ ‘‘package description,’’ and 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
69858 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

‘‘number of individual units produced’’; 

(3) included language that discusses the 

time period during which outsourcing 

facilities must submit product reports; 

(4) included the appropriate SPL 

document type category for outsourcing 

facilities submitting a product report 

and a reference to detailed instructions 

on how to submit information using 

SPL; (5) clarified that reports submitted 

under section 503B(b)(2) of the FD&C 

Act (21 U.S.C. 353b(b)(2)) are exempt 

from inspection unless the Secretary 

finds that such an exemption would be 

inconsistent with the protection of the 

public health; and (6) made grammatical 

and other minor editorial changes for 

clarity. 

In some cases, received comments 

raised issues that were not directly 

pertinent to the topics addressed in the 

draft. This revised draft guidance 

explains that registered outsourcing 

facilities must provide reports to FDA 

on compounded drugs in SPL format 

using FDA’s electronic submissions 

system. It supersedes the draft guidance 

entitled ‘‘Interim Product Reporting for 

Human Drug Compounding Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

Section 503B(b)(2)(B) of the FD&C Act 

provides that a facility that elects to 

register with FDA as an outsourcing 

facility is required to report to FDA 

information about the drugs 

compounded at that outsourcing facility 

in the form and manner as FDA may 

‘‘prescribe by regulation or guidance.’’ 

Congress gave FDA explicit statutory 

authority to establish binding 

requirements on this topic in guidance. 

Therefore, this guidance is not subject to 

the usual restrictions in FDA’s good 

guidance practice regulations (e.g., the 

requirements that guidances not 

establish legally enforceable 

responsibilities and that guidances 

prominently display a statement of the 

document’s nonbinding effect); see 21 

CFR 10.115(d)(1)). 

As provided in section 503B of the 

DQSA, this revised draft guidance 

explains the form and manner in which 

registered outsourcing facilities are 

required to submit drug reporting 

information. This revised draft 

guidance, when finalized, will prescribe 

the form and manner for submitting 

drug product reports to FDA under 

section 503B of the FD&C Act and will 

have binding effect under section 

503B(b)(2)(B). Until this draft guidance 

is finalized, FDA will accept drug 

product reports submitted in accordance 

with the form and manner described in 

FDA’s initial draft guidance on this 

subject. However, FDA strongly 

encourages outsourcing facilities to 

submit drug product reports as 

described in this revised draft guidance. 

Elsewhere in this issue of the Federal 

Register, FDA is making available a 

final guidance on registration for human 

drug compounding outsourcing 

facilities under section 503B of the 

FD&C Act. 

II. Paperwork Reduction Act 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information that they conduct or 

sponsor. ‘‘Collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA, 44 

U.S.C. 3506(c)(2)(A), requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this 

document, FDA invites comments on 

the following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Under the revised draft guidance, 

registered outsourcing facilities must 

submit to FDA a report identifying all 

drugs compounded by the facility 

during the previous 6-month period. 

The report must be submitted upon 

initial registration as an outsourcing 

facility, once in June, and once in 

December of each year. The report must 

include the following information for all 

drugs compounded at the outsourcing 

facility during the previous 6-month 

period: 

• The active ingredient and strength 

of active ingredient per unit 

• The source of the active ingredient 

(bulk or finished) 

• The National Drug Code (NDC) 

number of the source drug or bulk active 

ingredient, if available 

• The dosage form and route of 

administration 

• The package description 

• The number of individual units 

produced 

• The NDC number of the final 

product, if assigned 

Product reports must be submitted to 

FDA electronically in SPL format, as 

described in the revised draft guidance. 

Outsourcing facilities can request a 

waiver from the electronic submission 

process by submitting a written request 

to FDA explaining why the use of 

electronic means is not reasonable for 

them. 

Based on our familiarity with 

outsourcing facilities, we estimate that 

annually a total of approximately 50 

outsourcing facilities (‘‘number of 

respondents’’ in table 1, row 1) will 

submit to FDA at the time of initial 

registration a report identifying all drugs 

compounded in the facility. We also 

estimate that these outsourcing facilities 

will submit a total of approximately 50 

reports for compounded drugs 

containing the information specified in 

the draft guidance (‘‘total annual 

responses’’ in table 1, row 1). We 

estimate that preparing and submitting 

this information electronically will take 

approximately 2 hours per report 

(‘‘average burden per response’’ in table 

1, row 1). We expect to receive no more 

than one waiver request from this 

electronic submission process (‘‘total 

annual responses’’ in table 1, row 2), 

and each request should take 

approximately 1 hour to prepare and 

submit to us (‘‘average burden per 

response’’ in table 1, row 2). 

We also estimate that a total of 

approximately 50 outsourcing facilities 

(‘‘number of respondents’’ in table 2, 

row 1) will submit to FDA a report twice 

each year identifying all drugs 

compounded at the facility. We estimate 

that these outsourcing facilities will 

submit a total of approximately 50 

reports in December and 50 reports in 

June containing the information 

specified in the draft revised guidance 

(‘‘total annual responses’’ in table 2, row 

1). We estimate that preparing and 

submitting this information 

electronically will take approximately 2 

hours per report (‘‘average burden per 

response’’ in table 2, row 1). We expect 

to receive no more than one waiver 

request from the electronic submission 

process (‘‘total annual responses’’ in 

table 2, row 2), and each request should 

take approximately 1 hour to prepare 

and submit to us (‘‘average burden per 

response’’ in table 2, row 2). 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69859 

TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1

Product reporting for compounding outsourcing facilities Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of Initial Product Report ................................... 50 1 50 2 100 

Waiver Request from Electronic Submission of Initial Product Report ......................................................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 101 

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

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Product reporting for compounding outsourcing facilities Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total hours 

Submission of December Product Report ........................... 50 1 50 2 100 

Submission of June Product Report .................................... 50 1 50 2 100 

Waiver Request from Electronic Submission of Product 

Reports ............................................................................. 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 201 

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

III. Comments 

Interested persons can 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 can be viewed at 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 either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27691 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1429] 

Registration of Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the FD&C Act; 

Final Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final guidance for 

industry entitled ‘‘Registration of 

Human Drug Compounding Outsourcing 

Facilities Under Section 503B of the 

FD&C Act.’’ The guidance addresses 

new provisions in the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as amended by the Drug Quality and 

Security Act (DQSA). The guidance is 

intended to assist human drug 

compounders that elect to register as 

outsourcing facilities in registering, reregistering, or de-registering with FDA. 

The guidance provides information on 

how an outsourcing facility should 

submit facility registration information 

electronically in structured product 

labeling (SPL) format using FDA’s 

electronic submission system. This 

guidance reflects the Agency’s current 

thinking on the issues addressed by the 

guidance. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the final guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

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 final guidance document. 

Submit electronic comments on the 

final 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: Soo 

Jin Park, Drug Registration and Listing 

Team, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–3100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Registration of Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the FD&C Act.’’ 

This guidance is being issued consistent 

with the new authority conferred to 

FDA in the DQSA (Pub. L. 113–54). In 

that legislation, Congress created a new 

category for certain facilities that 


asabaliauskas on DSK5VPTVN1PROD with NOTICES