Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 51176-51178 [2014-20276]

Download as PDF 51176 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices Immigrants (USCRI), served more clients than it had originally planned for in its budget. Without the additional funding, significant cuts in services to clients would be made and the enrollment of new clients will be limited. With the supplemental funding, USCRI will be able to ensure that all of the clients’ essential needs will be met. Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–20314 Filed 8–26–14; 8:45 am] BILLING CODE 4184–01–P Statutory Authority: Trafficking Victims Protection Act of 2000 (TVPA), as amended, Section 107(b)(1)(B), 22 U.S.C. 7105(b)(1)(B), authorizes funding for benefits and services to foreign victims of severe forms of trafficking in persons in the United States, potential victims of trafficking seeking HHS Certification, and certain family members. DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.598] Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the U.S. Committee for Refugees and Immigrants in Arlington, VA Melody Wayland, Senior Grants Policy Specialist, Office of Administration/Division of Grants Policy. [FR Doc. 2014–20326 Filed 8–26–14; 8:45 am] BILLING CODE 4184–47–P Office of Refugee Resettlement, ACF, HHS. ACTION: Announcement of the award of a single-source program expansion supplement to the U.S. Committee for Refugees and Immigrants (USCRI) to support expanded services to foreign trafficking victims, potential trafficking victims, and certain family members. AGENCY: The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to U.S. Committee for Refugees and Immigrants in Arlington, Virginia for a total of $361,286. The supplemental funding will ensure sufficient that clients’ essential needs, such as housing, transportation, communication, food, and medical care will be met. DATES: The period of support under these supplements is June 26, 2014 through September 29, 2014. FOR FURTHER INFORMATION CONTACT: Maggie Wynne, Director, Division of Anti-Trafficking in Persons, Office of Refugee Resettlement, 901 D Street SW., Washington, DC 20447, Telephone (202) 401–4664. Email: maggie.wynne@ acf.hhs.gov SUPPLEMENTARY INFORMATION: The National Human Trafficking Victim Assistance Program (NHTVAP) provides funding for comprehensive case management services on a per capita basis. The NHTVAP grantees help victims gain access to housing, employability services, mental health screening and therapy, medical care, and some legal services, enabling them to live free of violence and exploitation. During FY 2014, the current grantee, U.S. Committee for Refugees and mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Announcement of the Intent To Award a Single-Source Cooperative Agreement to the National Association of State Units on Aging and Disability Administration for Community Living, HHS. ACTION: Notice. AGENCY: The Administration for Community Living (ACL) announces the intent to award a single-source cooperative agreement in the amount of $220,000 to the National Association of State Units on Aging and Disability (NASUAD) to support and stimulate the expansion of work already under way by NASUAD to create a valid and reliable National Core Indicator (NCI) Survey for older adults and people with physical disabilities. DATES: The award will be issued for a project period of September 30, 2014 through September 29, 2015. FOR FURTHER INFORMATION CONTACT: Shawn Terrell, Center for Disability and Aging Policy, Administration for Community Living, 1 Massachusetts Avenue NW., Washington, DC 20001. Telephone: 202–357–3517; Email: Shawn.Terrell@acl.hhs.gov. SUPPLEMENTARY INFORMATION: In 2009, NASUAD started to partner with National Association of State Directors of Developmental Disabilities Services (NASDDDS) and Human Services Research Institute (HSRI) to expand the NCI to include older adults and people with physical disabilities. As a result of the NASUAD/NASDDDS/HSRI SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 partnership, the expanded tool, National Core Indicators—Aging and Disability (NCI–AD), is currently being piloted in 3 states. NASUAD is the lead partner for the NCI–AD project. With this one-year of grant funding, through a cooperative agreement, NASUAD will be able to recruit additional state aging and disability agencies to participate in the National Core Indicators—Aging & Disability (NCI–AD) project and expand the project’s technical assistance to the three states already participating in this project. This program is authorized under Title IV of the Older Americans Act (OAA) (42 U.S.C. 3032), as amended by the Older Americans Act Amendments of 2006, Public Law 109–365 (Catalog of Federal Domestic Assistance 93.048, Title IV Discretionary Projects) as well as Title I, Subtitle E of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15081), Public Law 106–402 (Catalog of Federal Domestic Assistance 93.631, Developmental Disabilities Projects of National Significance). Date: August 21, 2014. Sharon Lewis, Principal Deputy Administrator, Administration for Community Living. [FR Doc. 2014–20370 Filed 8–26–14; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1429] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by September 26, 2014. SUMMARY: E:\FR\FM\27AUN1.SGM 27AUN1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. mstockstill on DSK4VPTVN1PROD with NOTICES ADDRESSES: Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability In the Federal Register of December 4, 2013 (78 FR 72899), FDA announced the availability of a draft guidance for industry entitled ‘‘Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ The guidance is being issued to implement provisions added to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Drug Quality and Security Act (DQSA), which created a statutory category of ‘‘outsourcing facilities’’ that compound human drugs. Section 503B of the FD&C Act (21 U.S.C. 353b) allows compounders to register with FDA as outsourcing facilities. Drug products compounded in an outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to label products with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section 503B are met. The guidance discusses the process for registration of outsourcing facilities. Under the guidance, facilities that elect to register must submit the following registration information to FDA for each facility: • Name of the facility; • place of business; • unique facility identifier; • point of contact email address and phone number; • whether the facility intends to compound drugs that appear on FDA’s VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e); and • an indication of whether the facility compounds from bulk drug substances, and if so, whether it compounds sterile or nonsterile drugs from bulk drug substances. After initial registration, outsourcing facilities that wish to remain an outsourcing facility must re-register annually between October 1 and December 31 of each year. Registration information should be submitted to FDA electronically using the Structured Product Labeling (SPL) format and in accordance with section IV of the FDA guidance entitled ‘‘Providing Regulatory Submissions in Electronic Format— Drug Establishment Registration and Drug Listing.’’ In the draft guidance issued on December 4, 2013, FDA described an alternative interim registration mechanism for use after initial passage of the DQSA and until September 30, 2014. The final guidance specifies the use of the SPL format for all registrations. Under the final guidance, outsourcing facilities may request a waiver from the SPL electronic submission process by submitting a written request to FDA explaining why the use of electronic means is not reasonable for the person requesting the waiver. In response to the December 4, 2013, Federal Register notice, FDA received nine comments on the draft guidance, several of which raised issues pertaining to the information collection provisions in the draft guidance. The four primary issues raised are addressed below. (Issue 1) Several commenters noted that the final guidance should clarify what product information will be included on the public list of registered outsourcing facilities required under section 503B(b)(1)(B)(ii) of the FD&C Act. Specifically, page 4, lines 133–134, of the draft guidance state that ‘‘information collected from the outsourcing facility registration, as well as certain product information, will be published in a list’’ authorized under section 503B(b)(1)(B)(ii) of the FD&C Act. The commenters requested assurances that confidential information submitted in product reports would remain confidential and not be posted on the Web. Other commenters requested clarification about how often the information will be updated. (Response) FDA has clarified the guidance. Specifically, the guidance now reads: ‘‘Section 503B(b)(1)(B)(ii) of the FD&C Act requires FDA to publish on the Internet a list of registered outsourcing facilities that includes the name of each registered outsourcing PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 51177 facility, the state in which it is located, whether the facility compounds from bulk drug substances and whether such compounding from bulk drug substances is for sterile or non-sterile drugs. FDA will publish the information required, as well as the date of registration as an outsourcing facility and certain publicly disclosable information related to past FDA inspections and compliance actions. FDA intends to update the list of registered outsourcing facilities weekly.’’ Some of the commenters may have been confusing disclosure of registration information with disclosure of proprietary information required to be reported under section 503B(b)(2) of the FD&C Act. That provision specifies that, upon initially registering as an outsourcing facility, once during the month of June of each year, and once during the month of December of each year, each facility that registers with the Secretary of Health and Human Services as an outsourcing facility shall submit to the Secretary a report providing certain information about the drugs that were compounded by the facility during the previous 6-month period. Unlike section 503B(b)(1), section 503B(b)(2) of the FD&C Act does not require that information reported be posted and specifies that reports submitted under the provision shall be exempt from inspection unless the Secretary finds that such an exemption would be inconsistent with the protection of the public health (section 503B(b)(2)(C) of the FD&C Act). FDA intends to address product reporting information in a separate guidance, ‘‘Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.’’ At this time, FDA does not intend to routinely disclose such information. (Issue 2) Another commenter noted that all registration information from the outsourcing facility should be made public using the SPL format. The commenter suggested FDA obtain and make publicly available the following information: Name/license number of supervising pharmacist(s), an indicator of compliance registration or date of first and last registration, and a link to FDA disciplinary actions and to a list of recalled products for that outsourcing facility. (Response) The list of registered outsourcing facilities includes most of the information that the commenter suggested, including each facility’s date of registration as an outsourcing facility and any action FDA has taken based on the most recent inspection. FDA publishes drug product recalls in its E:\FR\FM\27AUN1.SGM 27AUN1 51178 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices weekly Enforcement Report, which includes a description of the products subject to the recall. The commenter can check the Enforcement Report to view drug products that have been recalled. FDA does not include the name/license number of the supervising pharmacist because section 503B of the FD&C Act does not require facilities to provide this information to FDA when registering. This information is not in SPL format because FDA includes information in this list that is not captured in SPL, such as FDA regulatory actions. (Issue 3) One commenter requested insight on how FDA intends to communicate with industry those facilities that had previously registered as human drug compounders before the implementation of section 503B and those that are now registering under section 503B of the FD&C Act. (Response) FDA has made available on the Internet a list of the facilities that have registered under section 503B of the FD&C Act as outsourcing facilities. FDA does not have a list of facilities that had previously registered as human drug compounders before section 503B of the FD&C Act was enacted as there was no category of registered human drug compounder before this. Some human drug compounding facilities may have registered prior to the enactment of section 503B as human drug manufacturers under section 510 of the FD&C Act (21 U.S.C. 360). A list of all firms that are registered as manufacturers under section 510 is available to the public on FDA’s Drug Establishments Current Registration Site, which is separate from the list of outsourcing facilities that have registered under section 503B of the FD&C Act. (Issue 4) Another commenter noted that FDA should define what would constitute an undue burden justifying the granting of a waiver from the submission of registration information electronically. (Response) Section 503B(b)(3) of the FD&C Act specifies the standard FDA is to use to determine whether a waiver should be granted. FDA may grant a waiver if it finds that ‘‘use of electronic means is not reasonable for the person requesting the waiver.’’ FDA does not anticipate many instances in which electronic submission of registration information will not be reasonable for the person requesting the waiver, because the information requested is minimal, and the electronic system for submitting the information is an Internet-based system accessible to all firms seeking to register. Because human drug compounders are not currently required to register and report as outsourcing facilities, it is difficult to anticipate the number of outsourcing Number of responses per respondent Number of respondents Compounding outsourcing facility facilities that will participate in the process. As a result of comments received on the ‘‘Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act,’’ FDA has increased its estimates of the number of outsourcing facilities that are subject to each guidance. We now estimate that 50 outsourcing facilities will register and pay establishment fees, and we have adjusted the other estimates in the table (except for the ‘‘average burden per response’’) accordingly. We estimate that 50 outsourcing facilities (‘‘number of respondents’’ and ‘‘total annual responses’’ in table 1, row 1) will annually submit to FDA registration information using the SPL format as specified in the guidance, and that preparing and submitting this information will take 4.5 hours per registrant (‘‘average burden per response’’ in table 1, row 1). We expect to receive no more than one waiver request from the electronic submission process annually (‘‘number of respondents’’ and ‘‘total annual responses’’ in table 1, row 2), and that each request should take 1 hour to prepare and submit to us (‘‘average burden per response’’ in table 1, row 2). FDA estimates the burden of this collection of information as follows: Average burden per response Total annual responses Total hours Electronic Submission of Registration Information Using SPL Format ...................................................................... Waiver Request From Electronic Submission of Registration Information ................................................................. 50 1 50 4.5 225 1 1 1 1 1 Total .............................................................................. ........................ ........................ ........................ ........................ 226 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 21, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. ACTION: The Food and Drug Administration is correcting a notice entitled ‘‘Biosimilar User Fee Rates for Fiscal Year 2015’’ that appeared in the Federal Register of August 1, 2014 (79 FR 44795). The document announced the rates for biosimilar user fees for fiscal year 2015. The document was published with the incorrect docket number. This document corrects that error. BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0007] Food and Drug Administration, HHS VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 Lisa Granger, Office of Policy, Food and Administration, 10990 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. FOR FURTHER INFORMATION CONTACT: Biosimilar User Fee Rates for Fiscal Year 2015; Correction PO 00000 Frm 00041 Fmt 4703 Sfmt 9990 In the Federal Register of Friday, August 1, 2014, in FR Doc. 2014–18112, the following correction is made: 1. On page 44795, in the third column, in the Docket No. heading, ‘‘[Docket No. FDA–2013–N–0007]’’ is corrected to read ‘‘[Docket No. FDA– 2014–N–0007]’’. SUPPLEMENTARY INFORMATION: SUMMARY: [FR Doc. 2014–20276 Filed 8–26–14; 8:45 am] AGENCY: Notice; correction. Dated: August 21, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–20332 Filed 8–26–14; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51176-51178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20276]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Registration of Human Drug Compounding Outsourcing Facilities Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
September 26, 2014.

[[Page 51177]]


ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oirasubmission@omb.eop.gov. 
All comments should be identified with the title. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Registration of Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; Availability

    In the Federal Register of December 4, 2013 (78 FR 72899), FDA 
announced the availability of a draft guidance for industry entitled 
``Registration for Human Drug Compounding Outsourcing Facilities Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The 
guidance is being issued to implement provisions added to the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) by the Drug Quality and 
Security Act (DQSA), which created a statutory category of 
``outsourcing facilities'' that compound human drugs. Section 503B of 
the FD&C Act (21 U.S.C. 353b) allows compounders to register with FDA 
as outsourcing facilities. Drug products compounded in an outsourcing 
facility can qualify for exemptions from the FDA approval requirements 
in section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to 
label products with adequate directions for use under section 502(f)(1) 
of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section 
503B are met. The guidance discusses the process for registration of 
outsourcing facilities.
    Under the guidance, facilities that elect to register must submit 
the following registration information to FDA for each facility:
     Name of the facility;
     place of business;
     unique facility identifier;
     point of contact email address and phone number;
     whether the facility intends to compound drugs that appear 
on FDA's drug shortage list in effect under section 506E of the FD&C 
Act (21 U.S.C. 356e); and
     an indication of whether the facility compounds from bulk 
drug substances, and if so, whether it compounds sterile or nonsterile 
drugs from bulk drug substances.
    After initial registration, outsourcing facilities that wish to 
remain an outsourcing facility must re-register annually between 
October 1 and December 31 of each year. Registration information should 
be submitted to FDA electronically using the Structured Product 
Labeling (SPL) format and in accordance with section IV of the FDA 
guidance entitled ``Providing Regulatory Submissions in Electronic 
Format--Drug Establishment Registration and Drug Listing.'' In the 
draft guidance issued on December 4, 2013, FDA described an alternative 
interim registration mechanism for use after initial passage of the 
DQSA and until September 30, 2014. The final guidance specifies the use 
of the SPL format for all registrations. Under the final guidance, 
outsourcing facilities may request a waiver from the SPL electronic 
submission process by submitting a written request to FDA explaining 
why the use of electronic means is not reasonable for the person 
requesting the waiver.
    In response to the December 4, 2013, Federal Register notice, FDA 
received nine comments on the draft guidance, several of which raised 
issues pertaining to the information collection provisions in the draft 
guidance. The four primary issues raised are addressed below.
    (Issue 1) Several commenters noted that the final guidance should 
clarify what product information will be included on the public list of 
registered outsourcing facilities required under section 
503B(b)(1)(B)(ii) of the FD&C Act. Specifically, page 4, lines 133-134, 
of the draft guidance state that ``information collected from the 
outsourcing facility registration, as well as certain product 
information, will be published in a list'' authorized under section 
503B(b)(1)(B)(ii) of the FD&C Act. The commenters requested assurances 
that confidential information submitted in product reports would remain 
confidential and not be posted on the Web. Other commenters requested 
clarification about how often the information will be updated.
    (Response) FDA has clarified the guidance. Specifically, the 
guidance now reads: ``Section 503B(b)(1)(B)(ii) of the FD&C Act 
requires FDA to publish on the Internet a list of registered 
outsourcing facilities that includes the name of each registered 
outsourcing facility, the state in which it is located, whether the 
facility compounds from bulk drug substances and whether such 
compounding from bulk drug substances is for sterile or non-sterile 
drugs. FDA will publish the information required, as well as the date 
of registration as an outsourcing facility and certain publicly 
disclosable information related to past FDA inspections and compliance 
actions. FDA intends to update the list of registered outsourcing 
facilities weekly.''
    Some of the commenters may have been confusing disclosure of 
registration information with disclosure of proprietary information 
required to be reported under section 503B(b)(2) of the FD&C Act. That 
provision specifies that, upon initially registering as an outsourcing 
facility, once during the month of June of each year, and once during 
the month of December of each year, each facility that registers with 
the Secretary of Health and Human Services as an outsourcing facility 
shall submit to the Secretary a report providing certain information 
about the drugs that were compounded by the facility during the 
previous 6-month period. Unlike section 503B(b)(1), section 503B(b)(2) 
of the FD&C Act does not require that information reported be posted 
and specifies that reports submitted under the provision shall be 
exempt from inspection unless the Secretary finds that such an 
exemption would be inconsistent with the protection of the public 
health (section 503B(b)(2)(C) of the FD&C Act). FDA intends to address 
product reporting information in a separate guidance, ``Electronic 
Product Reporting for Human Drug Compounding Outsourcing Facilities 
Under Section 503B of the FD&C Act.'' At this time, FDA does not intend 
to routinely disclose such information.
    (Issue 2) Another commenter noted that all registration information 
from the outsourcing facility should be made public using the SPL 
format. The commenter suggested FDA obtain and make publicly available 
the following information: Name/license number of supervising 
pharmacist(s), an indicator of compliance registration or date of first 
and last registration, and a link to FDA disciplinary actions and to a 
list of recalled products for that outsourcing facility.
    (Response) The list of registered outsourcing facilities includes 
most of the information that the commenter suggested, including each 
facility's date of registration as an outsourcing facility and any 
action FDA has taken based on the most recent inspection. FDA publishes 
drug product recalls in its

[[Page 51178]]

weekly Enforcement Report, which includes a description of the products 
subject to the recall. The commenter can check the Enforcement Report 
to view drug products that have been recalled. FDA does not include the 
name/license number of the supervising pharmacist because section 503B 
of the FD&C Act does not require facilities to provide this information 
to FDA when registering. This information is not in SPL format because 
FDA includes information in this list that is not captured in SPL, such 
as FDA regulatory actions.
    (Issue 3) One commenter requested insight on how FDA intends to 
communicate with industry those facilities that had previously 
registered as human drug compounders before the implementation of 
section 503B and those that are now registering under section 503B of 
the FD&C Act.
    (Response) FDA has made available on the Internet a list of the 
facilities that have registered under section 503B of the FD&C Act as 
outsourcing facilities. FDA does not have a list of facilities that had 
previously registered as human drug compounders before section 503B of 
the FD&C Act was enacted as there was no category of registered human 
drug compounder before this. Some human drug compounding facilities may 
have registered prior to the enactment of section 503B as human drug 
manufacturers under section 510 of the FD&C Act (21 U.S.C. 360). A list 
of all firms that are registered as manufacturers under section 510 is 
available to the public on FDA's Drug Establishments Current 
Registration Site, which is separate from the list of outsourcing 
facilities that have registered under section 503B of the FD&C Act.
    (Issue 4) Another commenter noted that FDA should define what would 
constitute an undue burden justifying the granting of a waiver from the 
submission of registration information electronically.
    (Response) Section 503B(b)(3) of the FD&C Act specifies the 
standard FDA is to use to determine whether a waiver should be granted. 
FDA may grant a waiver if it finds that ``use of electronic means is 
not reasonable for the person requesting the waiver.'' FDA does not 
anticipate many instances in which electronic submission of 
registration information will not be reasonable for the person 
requesting the waiver, because the information requested is minimal, 
and the electronic system for submitting the information is an 
Internet-based system accessible to all firms seeking to register. 
Because human drug compounders are not currently required to register 
and report as outsourcing facilities, it is difficult to anticipate the 
number of outsourcing facilities that will participate in the process.
    As a result of comments received on the ``Draft Guidance for 
Industry on Fees for Human Drug Compounding Outsourcing Facilities 
Under the Federal Food, Drug, and Cosmetic Act,'' FDA has increased its 
estimates of the number of outsourcing facilities that are subject to 
each guidance. We now estimate that 50 outsourcing facilities will 
register and pay establishment fees, and we have adjusted the other 
estimates in the table (except for the ``average burden per response'') 
accordingly.
    We estimate that 50 outsourcing facilities (``number of 
respondents'' and ``total annual responses'' in table 1, row 1) will 
annually submit to FDA registration information using the SPL format as 
specified in the guidance, and that preparing and submitting this 
information will take 4.5 hours per registrant (``average burden per 
response'' in table 1, row 1). We expect to receive no more than one 
waiver request from the electronic submission process annually 
(``number of respondents'' and ``total annual responses'' in table 1, 
row 2), and that each request should take 1 hour to prepare and submit 
to us (``average burden per response'' in table 1, row 2).
    FDA estimates the burden of this collection of information as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
Compounding outsourcing facility     Number of     responses per   Total annual     burden per     Total  hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Electronic Submission of                      50               1              50             4.5             225
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             226
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20276 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P