82 FR 48092 - 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
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 | 48092-48093 | |
| FR Document | 2017-22284 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Notices] [Pages 48092-48093] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22284] ----------------------------------------------------------------------- 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. 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 0910-0777. 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, 10A-12M, 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 Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0777--Extension This information collection supports the above captioned Agency guidance. A facility that compounds drugs may elect to register with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353b), as added by the Drug Quality and Security Act (DQSA). Drug products compounded in a registered outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355), 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)), and drug supply chain security requirements in section 582 of the FD&C Act (21 U.S.C. 360eee) if the requirements in section 503B of the FD&C Act are met. After the initial registration, under section 503B(b) of the FD&C Act, a facility that elects to register with FDA as an outsourcing facility must also do so annually between October 1 and December 31. Upon registration, the outsourcing facility must provide its name, place of business, a unique facility identifier, and a point of contact email address and phone number. The outsourcing facility must also indicate whether it intends to compound, within the next calendar year, a drug that appears on FDA's drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e), and whether it compounds from bulk drug substances, and, if so, whether it compounds sterile or non- sterile drugs from bulk drug substances. Outsourcing facilities that elect to register should 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; 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. 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.'' 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. In the Federal Register of June 20, 2017 (82 FR 28076), FDA published a 60-day notice requesting public [[Page 48093]] comment on the proposed collection of information. No comments were received. We therefore estimate the burden associated with the information collection as follows: Table 1--Estimated Annual Reporting Burden\1\ ---------------------------------------------------------------------------------------------------------------- Number of Compounding outsourcing facility Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Electronic Submission of 62 1 62 4.5 279 Registration Information Using SPL Format..................... Waiver Request From Electronic 1 1 1 1 1 Submission of Registration Information.................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 280 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We estimate that approximately 62 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 approximately 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 approximately 1 hour to prepare and submit to us (``average burden per response'' in table 1, row 2). Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22284 Filed 10-13-17; 8:45 am] BILLING CODE 4164-01-P
![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
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![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48093
comment on the proposed collection of We therefore estimate the burden
information. No comments were associated with the information
received. collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual
Compounding outsourcing facility responses per burden per Total hours
respondents responses
respondent response
Electronic Submission of Registration Information Using
SPL Format ...................................................................... 62 1 62 4.5 279
Waiver Request From Electronic Submission of Registra-
tion Information ................................................................. 1 1 1 1 1
Total .............................................................................. ........................ ........................ ........................ ........................ 280
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that approximately 62 September 21, 2017 (82 FR 44185). The announcing the availability of a draft
outsourcing facilities (‘‘number of document announced the withdrawal of guidance for industry entitled ‘‘Post-
respondents’’ and ‘‘total annual approval of 27 abbreviated new drug Complete Response Letter Meetings
responses’’ in table 1, row 1) will applications (ANDAs) from multiple Between FDA and ANDA Applicants
annually submit to FDA registration applicants. The document was Under GDUFA.’’ This guidance is
information using the SPL format as published with the incorrect docket intended to clarify the criteria for
specified in the guidance, and that number. This document corrects that granting post-complete response letter
preparing and submitting this error. (CRL) meeting requests and the scope of
information will take approximately 4.5 discussions for granted meeting
FOR FURTHER INFORMATION CONTACT: Lisa
hours per registrant (‘‘average burden requests. This guidance provides
Granger, Office of Policy, Food and Drug
per response’’ in table 1, row 1). We procedures that will promote well-
Administration, 10903 New Hampshire
expect to receive no more than one managed post-CRL meetings and help
Ave., Bldg. 32, Rm. 3330, Silver Spring,
waiver request from the electronic ensure that such meetings are scheduled
MD 20993–0002, 301–796–9115,
submission process annually (‘‘number and conducted in accordance with the
lisa.granger@fda.hhs.gov.
of respondents’’ and ‘‘total annual time frames set forth in the GDUFA
responses’’ in table 1, row 2), and that SUPPLEMENTARY INFORMATION: In the
Reauthorization Performance Goals and
each request should take approximately Federal Register of Thursday, Program Enhancements Fiscal Years
1 hour to prepare and submit to us September 21, 2017, in FR Doc. 2017– 2018–2022 (GDUFA II Goals or
(‘‘average burden per response’’ in table 20107, on page 44185 the following Commitment Letter).
1, row 2). correction is made:
On page 44185, in the second column, DATES: Submit either electronic or
Dated: October 10, 2017. under the docket number FDA–2017–N– written comments on the draft guidance
Anna K. Abram, 5526 is corrected to read ‘‘FDA–2017– by December 15, 2017 to ensure that the
Deputy Commissioner for Policy, Planning, N–5226’’. Agency considers your comment on this
Legislation, and Analysis. draft guidance before it begins work on
Dated: October 11, 2017.
[FR Doc. 2017–22284 Filed 10–13–17; 8:45 am] the final version of the guidance.
Anna K. Abram,
BILLING CODE 4164–01–P ADDRESSES: You may submit comments
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
on any guidance at any time as follows:
DEPARTMENT OF HEALTH AND [FR Doc. 2017–22299 Filed 10–13–17; 8:45 am] Electronic Submissions
HUMAN SERVICES BILLING CODE 4164–01–P
Submit electronic comments in the
following way:
Food and Drug Administration
• Federal eRulemaking Portal:
DEPARTMENT OF HEALTH AND
[Docket No. FDA–2017–N–5226] https://www.regulations.gov. Follow the
HUMAN SERVICES
instructions for submitting comments.
Department of Health and Human Comments submitted electronically,
Food and Drug Administration
Services, Supply Service Center et al.; including attachments, to https://
Withdrawal of Approval of 27 [Docket No. FDA–2017–D–5928] www.regulations.gov will be posted to
Abbreviated New Drug Applications; the docket unchanged. Because your
Correction Post-Complete Response Letter
comment will be made public, you are
Meetings Between the Food and Drug
AGENCY: Food and Drug Administration, solely responsible for ensuring that your
Administration and Abbreviated New
HHS. comment does not include any
Drug Application Applicants Under the
ACTION: Notice; correction. confidential information that you or a
Generic Drug User Fee Act; Draft
third party may not wish to be posted,
ethrower on DSK3G9T082PROD with NOTICES
Guidance for Industry; Availability
SUMMARY: The Food and Drug such as medical information, your or
Administration is correcting a notice AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
entitled ‘‘Department of Health and HHS. confidential business information, such
Human Services, Supply Service Center ACTION: Notice of availability. as a manufacturing process. Please note
et al.; Withdrawal of Approval of 27 that if you include your name, contact
Abbreviated New Drug Applications’’ SUMMARY: The Food and Drug information, or other information that
that appeared in the Federal Register of Administration (FDA or Agency) is identifies you in the body of your
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Document Created: 2017-10-14 01:42:56
Document Modified: 2017-10-14 01:42:56
| 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, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 48092 |
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