82 FR 48090 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 198 (October 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 198 (October 16, 2017)
| Page Range | 48090-48092 | |
| FR Document | 2017-22283 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Notices] [Pages 48090-48092] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22283] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0329] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under 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. DATES: Fax written comments on the collection of information by November 15, 2017. 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 [email protected]. All comments should be identified with the OMB control number 0910-0776. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. 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 Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act OMB Control Number 0910-0776--Extension This information collection supports the Agency's guidance on fees for human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On November 27, 2013, the President signed the Drug Quality and Security Act (DQSA) (Pub. L. 113- 54) into law. The DQSA added a new section, 503B (21 U.S.C. 353B), to the FD&C Act, creating a category of entities called ``outsourcing facilities.'' Outsourcing facilities, as defined in section 503B(d)(4) of the FD&C Act, are facilities that meet certain requirements described in section 503B, including registering with FDA as an outsourcing facility and paying associated fees. 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 of the FD&C Act are met. The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under section 503B of the FD&C Act. Once an entity has elected to register as an outsourcing facility, it must pay certain fees to be registered as an outsourcing facility. The guidance describes the types and amounts of fees that outsourcing facilities must pay, the adjustments to fees required by law, the way in which outsourcing facilities may submit payment to FDA, the consequences of outsourcing facilities' failure to pay fees, and the way an outsourcing facility may qualify as a small business to obtain a reduction in fees. In the Federal Register of June 15, 2017 (82 FR 27493), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We therefore estimate the burden associated with the information collection as follows: [[Page 48091]] Table 1--Estimated Annual Reporting Burden--Establishment Fee \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Payment of annual 60 1 60 .5 (30 minutes) 30 establishment fee........... Request for Small Business 15 1 15 25 375 Establishment Fee Reduction (Form FDA 3908)............. ---------------------------------------------------------------------------------- Total.................... .............. .............. .............. ................. 405 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Reporting Burden--Re-Inspection Fee and Dispute Resolution Requests \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Payment of re-inspection fee. 15 1 15 .5 (30 minutes) 7.50 Reconsideration request...... 3 1 3 1 3 Appeal request............... 1 1 1 1 1 ---------------------------------------------------------------------------------- Total.................... .............. .............. .............. ................. 11.50 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of recordkeeping Number of record per Total annual Average burden Total hours recordkeepers recordkeeper records per record ---------------------------------------------------------------------------------------------------------------- Copy of small business 15 1 15 .5 (30 minutes) 7.50 designation letter.......... ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. As described in section III.A of the guidance, upon receiving registration information from a facility seeking to register as an outsourcing facility, FDA will send an invoice for an establishment fee to the outsourcing facility. The invoice contains instructions for paying the establishment fee, as discussed in section III.E of the guidance. This process would be repeated annually under the timeframes described in the guidance. An outsourcing facility is not considered registered until the required establishment fee is paid for that fiscal year. We estimate that annually a total of 60 outsourcing facilities (``no. of respondents'' in table 1, row 1) will pay to FDA 60 establishment fees (``total annual responses'' in table 1, row 1) as described in the guidance. We also estimate that it will take an outsourcing facility 0.5 hour to prepare and submit to FDA each establishment fee (``average burden per response'' in table 1, row 1). As described in section III.C of the guidance, outsourcing facilities that are re-inspected will be assessed a re-inspection fee for each re-inspection. The re-inspection fee is designed to reimburse FDA when it must visit a particular outsourcing facility more than once because of noncompliance identified during a previous inspection. A re- inspection fee will be incurred for each re-inspection that occurs. After FDA conducts a re-inspection, we will send an invoice to the email address indicated in the facility's registration file. The invoice contains instructions for paying the re-inspection fee, as discussed in section III.E of the guidance. We estimate that annually a total of 15 outsourcing facilities (``no. of respondents'' in table 2, row 1) will pay to FDA 15 re- inspection fees (``total annual responses'' in table 2, row 1) as described in the guidance. We also estimate that it will take an outsourcing facility 0.5 hour to prepare and submit to FDA each re- inspection fee (``average burden per response'' in table 2, row 1). As described in section III.D of the guidance, certain outsourcing facilities may qualify for a small business reduction in the amount of the annual establishment fee. To qualify for this reduction, an outsourcing facility must submit to FDA a written request certifying that the entity meets the requirements for the reduction. For every fiscal year that the firm seeks to qualify as a small business and receive the fee reduction, the written request must be submitted to FDA by April 30 of the preceding fiscal year. For example, an outsourcing facility must submit a written request for the small business reduction by April 30, 2015, to qualify for a reduction in the fiscal year 2016 annual establishment fee. As described in the guidance, section 744K of the FD&C Act (21 U.S.C. 379j-62) also requires an outsourcing facility to submit its written request for a small business reduction in a format specified by FDA in the guidance. The guidance specifies that Form FDA 3908 is the format for submitting requests for a small business fee reduction. We estimate that annually a total of 15 outsourcing facilities (``no. of respondents'' in table 1, row 2) will submit to FDA a request for a small business reduction in the amount of the annual establishment fee. We estimate that 15 outsourcing facilities will submit Form FDA 3908 (``total annual responses'' in table 1, row 2) to FDA annually, as described in the guidance, and that it will take an outsourcing facility 25 hours to prepare and submit to FDA each Form FDA 3908 (``average burden per response'' in table 1, row 2). [[Page 48092]] As described in section III.D of the guidance, those outsourcing facilities that request a small business reduction in the amount of the annual establishment fee will receive a small business designation letter notifying the facility of FDA's decision. Outsourcing facilities eligible to pay a reduced fee should maintain a copy of the small business designation letter applicable to that fiscal year for their records. We estimate that annually a total of 15 outsourcing facilities (``no. of recordkeepers'' in table 3) will keep a copy of their small business designation letter (``total annual records'' in table 3), and that maintaining each record will take 0.5 hour (``average burden per recordkeeping'' in table 3). As described in section V.B of the guidance, an outsourcing facility may request reconsideration under 21 CFR 10.75 of an FDA decision related to the fee provisions of section 744K of the FD&C Act. As explained in the guidance, the request should state the facility's rationale for its position that the decision was in error and include any additional information that is relevant to the outsourcing facility's argument. We estimate that a total of three outsourcing facilities (``no. of respondents'' in table 2, row 2) annually will submit to FDA a request for reconsideration as described in the guidance. We estimate that it will take an outsourcing facility approximately 1 hour to prepare and submit to FDA each request for reconsideration (``average burden per response'' in table 2, row 2). As described in section V.B of the guidance, an outsourcing facility may appeal, as set forth in Sec. 10.75, an FDA denial of a request for reconsideration of an FDA decision related to the fee provisions of section 744K of the FD&C Act. We estimate that a total of one outsourcing facility (``no. of respondents'' in table 2, row 3) annually will submit an appeal of an FDA denial of a request for reconsideration. We estimate that it will take an outsourcing facility 1 hour to prepare and submit each appeal under Sec. 10.75 (``average burden per response'' in table 2, row 3). Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22283 Filed 10-13-17; 8:45 am] BILLING CODE 4164-01-P
![48090 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Application ....................................................................................................... 52 1 40 2,080
Annual Report .................................................................................................. 52 1 24 1,248
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Guidance for Industry on Fees for
Hours: 3,328. HUMAN SERVICES Human Drug Compounding
In compliance with the requirements Outsourcing Facilities Under Sections
of Section 3506(c)(2)(A) of the Food and Drug Administration 503B and 744K of the FD&C Act OMB
Control Number 0910–0776—Extension
Paperwork Reduction Act of 1995, the
Administration for Children and [Docket No. FDA–2014–D–0329] This information collection supports
Families is soliciting public comment the Agency’s guidance on fees for
on the specific aspects of the Agency Information Collection human drug compounding outsourcing
Activities; Submission for Office of facilities under the Federal Food, Drug,
information collection described above.
Management and Budget Review; and Cosmetic Act (the FD&C Act). On
Copies of the proposed collection of
Comment Request; Guidance for November 27, 2013, the President
information can be obtained and
Industry on Fees for Human Drug signed the Drug Quality and Security
comments may be forwarded by writing
Compounding Outsourcing Facilities Act (DQSA) (Pub. L. 113–54) into law.
to the Administration for Children and The DQSA added a new section, 503B
Under the Federal Food, Drug, and
Families, Office of Planning, Research, (21 U.S.C. 353B), to the FD&C Act,
Cosmetic Act
and Evaluation, 330 C Street SW., creating a category of entities called
Washington, DC 20201, Attn: ACF AGENCY: Food and Drug Administration, ‘‘outsourcing facilities.’’ Outsourcing
Reports Clearance Officer. Email HHS. facilities, as defined in section
address: infocollection@acf.hhs.gov. All 503B(d)(4) of the FD&C Act, are
requests should be identified by the title ACTION: Notice. facilities that meet certain requirements
of the information collection. described in section 503B, including
SUMMARY: The Food and Drug registering with FDA as an outsourcing
The Department specifically requests
Administration (FDA) is announcing facility and paying associated fees. Drug
comments on (a) whether the proposed
that a proposed collection of products compounded in an
collection of information is necessary
information has been submitted to the outsourcing facility can qualify for
for the proper performance of the
Office of Management and Budget exemptions from the FDA approval
functions of the agency, including (OMB) for review and clearance under requirements in section 505 of the FD&C
whether the information shall have the Paperwork Reduction Act of 1995. Act (21 U.S.C. 355), and the requirement
practical utility; (b) the accuracy of the
DATES: Fax written comments on the to label products with adequate
agency’s estimate of the burden of the directions for use under section
proposed collection of information; (c) collection of information by November
502(f)(1) of the FD&C Act (21 U.S.C.
the quality, utility, and clarity of the 15, 2017.
352(f)(1)), if the requirements in section
information to be collected; and (d) ADDRESSES: To ensure that comments on 503B of the FD&C Act are met.
ways to minimize the burden of the the information collection are received, The guidance is intended for entities
collection of information on OMB recommends that written that compound human drugs and elect
respondents, including through the use comments be faxed to the Office of to register as outsourcing facilities
of automated collection techniques or Information and Regulatory Affairs, under section 503B of the FD&C Act.
other forms of information technology. OMB, Attn: FDA Desk Officer, Fax: 202– Once an entity has elected to register as
Consideration will be given to 395–7285, or emailed to oira_ an outsourcing facility, it must pay
comments and suggestions submitted submission@omb.eop.gov. All certain fees to be registered as an
within 60 days of this publication. comments should be identified with the outsourcing facility. The guidance
OMB control number 0910–0776. Also describes the types and amounts of fees
Mary Jones, that outsourcing facilities must pay, the
include the FDA docket number found
ACF/OPRE Reports Clearance Officer. in brackets in the heading of this adjustments to fees required by law, the
[FR Doc. 2017–22294 Filed 10–13–17; 8:45 am] document. way in which outsourcing facilities may
BILLING CODE 4184–29–P
submit payment to FDA, the
FOR FURTHER INFORMATION CONTACT: consequences of outsourcing facilities’
Domini Bean, Office of Operations, failure to pay fees, and the way an
Food and Drug Administration, Three outsourcing facility may qualify as a
White Flint North, 10A63, 11601 small business to obtain a reduction in
Landsdown St., North Bethesda, MD fees.
20852, 301–796–5733, PRAStaff@ In the Federal Register of June 15,
ethrower on DSK3G9T082PROD with NOTICES
fda.hhs.gov. 2017 (82 FR 27493), we published a 60-
day notice requesting public comment
SUPPLEMENTARY INFORMATION: In on the proposed extension of this
compliance with 44 U.S.C. 3507, FDA collection of information. No comments
has submitted the following proposed were received. We therefore estimate the
collection of information to OMB for burden associated with the information
review and clearance. collection as follows:
VerDate Sep<11>2014 16:59 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1](https://thefederalregister.org/doc/82_FR_48288/page/1.svg)
![48092 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
As described in section III.D of the DEPARTMENT OF HEALTH AND added by the Drug Quality and Security
guidance, those outsourcing facilities HUMAN SERVICES Act (DQSA). Drug products
that request a small business reduction compounded in a registered outsourcing
in the amount of the annual Food and Drug Administration facility can qualify for exemptions from
establishment fee will receive a small [Docket No. FDA–2013–N–1429] the FDA approval requirements in
business designation letter notifying the section 505 of the FD&C Act (21 U.S.C.
facility of FDA’s decision. Outsourcing Agency Information Collection 355), the requirement to label products
facilities eligible to pay a reduced fee Activities; Submission for Office of with adequate directions for use under
should maintain a copy of the small Management and Budget Review; section 502(f)(1) of the FD&C Act (21
business designation letter applicable to Comment Request; Guidance for U.S.C. 352(f)(1)), and drug supply chain
that fiscal year for their records. Industry on Registration of Human security requirements in section 582 of
Drug Compounding Outsourcing the FD&C Act (21 U.S.C. 360eee) if the
We estimate that annually a total of 15 Facilities Under Section 503B of the requirements in section 503B of the
outsourcing facilities (‘‘no. of Federal Food, Drug, and Cosmetic Act FD&C Act are met.
recordkeepers’’ in table 3) will keep a After the initial registration, under
copy of their small business designation AGENCY: Food and Drug Administration, section 503B(b) of the FD&C Act, a
letter (‘‘total annual records’’ in table 3), HHS. facility that elects to register with FDA
and that maintaining each record will ACTION: Notice. as an outsourcing facility must also do
take 0.5 hour (‘‘average burden per so annually between October 1 and
SUMMARY: The Food and Drug
recordkeeping’’ in table 3). December 31. Upon registration, the
Administration (FDA) is announcing
As described in section V.B of the outsourcing facility must provide its
that a proposed collection of
guidance, an outsourcing facility may name, place of business, a unique
information has been submitted to the
facility identifier, and a point of contact
request reconsideration under 21 CFR Office of Management and Budget
email address and phone number. The
10.75 of an FDA decision related to the (OMB) for review and clearance under
outsourcing facility must also indicate
fee provisions of section 744K of the the Paperwork Reduction Act of 1995.
whether it intends to compound, within
FD&C Act. As explained in the DATES: Fax written comments on the the next calendar year, a drug that
guidance, the request should state the collection of information by November appears on FDA’s drug shortage list in
facility’s rationale for its position that 15, 2017. effect under section 506E of the FD&C
the decision was in error and include ADDRESSES: To ensure that comments on Act (21 U.S.C. 356e), and whether it
any additional information that is the information collection are received, compounds from bulk drug substances,
relevant to the outsourcing facility’s OMB recommends that written and, if so, whether it compounds sterile
argument. comments be faxed to the Office of or non-sterile drugs from bulk drug
We estimate that a total of three Information and Regulatory Affairs, substances.
outsourcing facilities (‘‘no. of OMB, Attn: FDA Desk Officer, Fax: 202– Outsourcing facilities that elect to
395–7285, or emailed to oira_ register should submit the following
respondents’’ in table 2, row 2) annually
submission@omb.eop.gov. All registration information to FDA for each
will submit to FDA a request for
comments should be identified with the facility:
reconsideration as described in the
OMB control number 0910–0777. Also • Name of the facility;
guidance. We estimate that it will take include the FDA docket number found • Place of business;
an outsourcing facility approximately 1 in brackets in the heading of this • Unique facility identifier;
hour to prepare and submit to FDA each document. • Point of contact email address and
request for reconsideration (‘‘average phone number;
FOR FURTHER INFORMATION CONTACT:
burden per response’’ in table 2, row 2). • Whether the facility intends to
Domini Bean, Office of Operations, compound drugs that appear on FDA’s
As described in section V.B of the Food and Drug Administration, Three
guidance, an outsourcing facility may drug shortage list in effect under section
White Flint North, 10A–12M, 11601 506E of the FD&C Act; and
appeal, as set forth in § 10.75, an FDA Landsdown St., North Bethesda, MD • An indication of whether the
denial of a request for reconsideration of 20852, 301–796–5733, PRAStaff@ facility compounds from bulk drug
an FDA decision related to the fee fda.hhs.gov. substances, and if so, whether it
provisions of section 744K of the FD&C SUPPLEMENTARY INFORMATION: In compounds sterile or nonsterile drugs
Act. compliance with 44 U.S.C. 3507, FDA from bulk drug substances.
We estimate that a total of one has submitted the following proposed Registration information should be
outsourcing facility (‘‘no. of collection of information to OMB for submitted to FDA electronically using
respondents’’ in table 2, row 3) annually review and clearance. the Structured Product Labeling (SPL)
will submit an appeal of an FDA denial format and in accordance with section
Guidance for Industry on Registration IV of the FDA guidance entitled
of a request for reconsideration. We of Human Drug Compounding
estimate that it will take an outsourcing ‘‘Providing Regulatory Submissions in
Outsourcing Facilities Under Section Electronic Format—Drug Establishment
facility 1 hour to prepare and submit 503B of the Federal Food, Drug, and
each appeal under § 10.75 (‘‘average Registration and Drug Listing.’’ Under
Cosmetic Act OMB Control Number the final guidance, outsourcing facilities
burden per response’’ in table 2, row 3). 0910–0777—Extension may request a waiver from the SPL
ethrower on DSK3G9T082PROD with NOTICES
Dated: October 10, 2017. This information collection supports electronic submission process by
Anna K. Abram, the above captioned Agency guidance. submitting a written request to FDA
Deputy Commissioner for Policy, Planning, A facility that compounds drugs may explaining why the use of electronic
Legislation, and Analysis. elect to register with FDA as an means is not reasonable.
[FR Doc. 2017–22283 Filed 10–13–17; 8:45 am] outsourcing facility under section 503B In the Federal Register of June 20,
BILLING CODE 4164–01–P
of the Federal Food, Drug, and Cosmetic 2017 (82 FR 28076), FDA published a
Act (the FD&C Act) (21 U.S.C. 353b), as 60-day notice requesting public
VerDate Sep<11>2014 16:59 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1](https://thefederalregister.org/doc/82_FR_48288/page/3.svg)
Document Created: 2017-10-14 01:42:49
Document Modified: 2017-10-14 01:42:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by November 15, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 48090 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR