82 FR 28076 - Agency Information Collection Activities: Proposed Collection; 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 117 (June 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 117 (June 20, 2017)
| Page Range | 28076-28078 | |
| FR Document | 2017-12838 |
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)] [Notices] [Pages 28076-28078] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12838] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1429] Agency Information Collection Activities: Proposed Collection; 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 or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Submit either electronic or written comments on the collection of information by August 21, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 21, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are [[Page 28077]] solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N 1429 for ``Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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: Under 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 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 concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 A facility that compounds drugs may elect to register with FDA as an outsourcing facility under section 503B of 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 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. 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 [[Page 28078]] 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. This information collection supports the Agency guidance discussed above. 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). FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Compounding outsourcing Number of responses per Total annual burden per Total hours facility respondents respondent responses 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. Dated: June 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning Legislation, and Analysis. [FR Doc. 2017-12838 Filed 6-19-17; 8:45 am] BILLING CODE 4164-01-P
![28076 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
20852, 301–796–8867, PRAStaff@ comments on these topics: (1) Whether the United States Code authorize
fda.hhs.gov. the proposed collection of information Federal agencies to rate applicants for
SUPPLEMENTARY INFORMATION: Under the is necessary for the proper performance Federal jobs. The proposed information
PRA (44 U.S.C. 3501–3520), Federal of FDA’s functions, including whether collection involves brief online
Agencies must obtain approval from the the information will have practical applications completed by applicants
Office of Management and Budget utility; (2) the accuracy of FDA’s applying to FDA’s fellowship programs.
(OMB) for each collection of estimate of the burden of the proposed These voluntary online applications
information they conduct or sponsor. collection of information, including the will allow the Agency to easily and
‘‘Collection of information’’ is defined validity of the methodology and efficiently elicit and review information
in 44 U.S.C. 3502(3) and 5 CFR assumptions used; (3) ways to enhance
from students and healthcare
1320.3(c) and includes Agency requests the quality, utility, and clarity of the
professionals who are interested in
or requirements that members of the information to be collected; and (4)
ways to minimize the burden of the becoming involved in FDA-wide
public submit reports, keep records, or activities. The process will reduce the
provide information to a third party. collection of information on
respondents, including through the use time and cost of submitting written
Section 3506(c)(2)(A) of the PRA (44 documentation to the Agency and lessen
U.S.C. 3506(c)(2)(A)) requires Federal of automated collection techniques,
when appropriate, and other forms of the likelihood of applications being
Agencies to provide a 60-day notice in misrouted within the Agency mail
the Federal Register concerning each information technology.
system. It will assist the Agency in
proposed collection of information, Application for Participation in FDA promoting and protecting the public
including each proposed extension of an Fellowship Programs (Formerly
existing collection of information, health by encouraging outside persons
Application for Participation in the
before submitting the collection to OMB to share their expertise with FDA.
FDA Commissioner’s Fellowship
for approval. To comply with this Program) FDA estimates the burden of this
requirement, FDA is publishing notice collection of information as follows:
of the proposed collection of OMB Control Number 0910–0780—
information set forth in this document. Extension
With respect to the following Sections 1104, 1302, 3301, 3304,
collection of information, FDA invites 3320, 3361, 3393, and 3394 of Title 5 of
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of responses
Activity annual burden per Total hours
respondents per responses response
respondent
Commissioner’s Fellowship Program .................................. 600 1 600 1.33 798
Regulatory Science Internship Program .............................. 250 1 250 1 250
Medical Device Fellowship Program ................................... 250 1 250 1 250
Total .............................................................................. ........................ ........................ ........................ ........................ 1,298
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 14, 2017. SUMMARY: The Food and Drug untimely filed comments will not be
Anna K. Abram, Administration (FDA or Agency) is considered. Electronic comments must
Deputy Commissioner for Policy, Planning, announcing an opportunity for public be submitted on or before August 21,
Legislation, and Analysis. comment on the proposed collection of 2017. The https://www.regulations.gov
[FR Doc. 2017–12781 Filed 6–19–17; 8:45 am] certain information by the Agency. electronic filing system will accept
BILLING CODE 4164–01–P Under the Paperwork Reduction Act of comments until midnight Eastern Time
1995 (PRA), Federal Agencies are at the end of August 21, 2017.
required to publish notice in the Comments received by mail/hand
DEPARTMENT OF HEALTH AND Federal Register concerning each delivery/courier (for written/paper
HUMAN SERVICES proposed collection of information, submissions) will be considered timely
including each proposed extension of an if they are postmarked or the delivery
Food and Drug Administration existing collection of information, and service acceptance receipt is on or
[Docket No. FDA–2013–N–1429] to allow 60 days for public comment in before that date.
response to the notice. This notice
Electronic Submissions
Agency Information Collection solicits comments on the information
Activities: Proposed Collection; collection in the guidance on Submit electronic comments in the
Comment Request; Guidance for registration of human drug following way:
Industry on Registration of Human compounding outsourcing facilities
• Federal eRulemaking Portal:
sradovich on DSK3GMQ082PROD with NOTICES
Drug Compounding Outsourcing under the Federal Food, Drug, and
https://www.regulations.gov. Follow the
Facilities Under Section 503B of the Cosmetic Act (the FD&C Act).
instructions for submitting comments.
Federal Food, Drug, and Cosmetic Act DATES: Submit either electronic or Comments submitted electronically,
written comments on the collection of including attachments, to https://
AGENCY: Food and Drug Administration,
information by August 21, 2017. www.regulations.gov will be posted to
HHS.
ADDRESSES: You may submit comments the docket unchanged. Because your
ACTION: Notice.
as follows. Please note that late, comment will be made public, you are
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![28078 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
• An indication of whether the electronic submission process by hours per registrant (‘‘average burden
facility compounds from bulk drug submitting a written request to FDA per response’’ in table 1, row 1). We
substances, and if so, whether it explaining why the use of electronic expect to receive no more than one
compounds sterile or nonsterile drugs means is not reasonable. waiver request from the electronic
from bulk drug substances. This information collection supports submission process annually (‘‘number
Registration information should be the Agency guidance discussed above. of respondents’’ and ‘‘total annual
submitted to FDA electronically using We estimate that approximately 62 responses’’ in table 1, row 2), and that
the Structured Product Labeling (SPL) outsourcing facilities (‘‘number of each request should take approximately
format and in accordance with section respondents’’ and ‘‘total annual
1 hour to prepare and submit to us
IV of the FDA guidance entitled responses’’ in table 1, row 1) will
(‘‘average burden per response’’ in table
‘‘Providing Regulatory Submissions in annually submit to FDA registration
Electronic Format—Drug Establishment information using the SPL format as 1, row 2).
Registration and Drug Listing.’’ Under specified in the guidance, and that FDA estimates the burden of this
the final guidance, outsourcing facilities preparing and submitting this collection of information as follows:
may request a waiver from the SPL information will take approximately 4.5
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Compounding Average
Number of responses Total annual
outsourcing burden per Total hours
respondents per responses
facility response
respondent
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.
Dated: June 15, 2017. (11) figures in PLoS One interactions between PPIP5K and the
Anna K. Abram, 11(10):e0164378, 2016 (hereafter inhibitors, UNC1011264 and
Deputy Commissioner for Policy, Planning referred to as ‘‘PLoS One 2016’’). UNC10225498, and Figure S5 for
Legislation, and Analysis. ORI found that Respondent falsified UNC10225354
[FR Doc. 2017–12838 Filed 6–19–17; 8:45 am] and/or fabricated data and text • Figure 6 results for the analysis of
BILLING CODE 4164–01–P published in PLoS One 2016, in Figures the mechanisms of inhibition of PPIP5K
2, 3, 4, 5, 6, 8, S1, S2, S3, S4, and S5, by UNC10112646 and UNC10225498
by claiming that a screening strategy of • Figures 8A and 8B results for high
DEPARTMENT OF HEALTH AND the kinase focused libraries, PKIS and performance liquid chromatography
HUMAN SERVICES 5K, was performed, when original data (HPLC) analysis for the effects of
do not exist to support the claims. UNC10112646 or UNC10225498 on
Office of the Secretary Respondent also claimed that three (3) PPIP5K activity and IP6K activity
inhibitory compounds for the inositol • Figures S1–S4 for experimental
Findings of Research Misconduct phosphate kinase, PPIP5K, were results further characterizing
AGENCY: Office of the Secretary, HHS. identified from the 5K library, when UNC10112646, UNC10225498, and
ACTION: Notice. these compounds, UNC10112646, other inhibitors, when the results were
UNC10225354, and UNC10225498, were not supported by the experimental
SUMMARY: Notice is hereby given that not part of the data set for the 5K records.
the Office of Research Integrity (ORI) library. Specifically, Respondent As a result of Respondent’s
has taken final action in the following falsified and/or fabricated the admission, NIH recommended that the
case: characterization of the inhibitor PLoS One 2016 paper be retracted.
Brandi M. Baughman, Ph.D., National compounds in: Dr. Baughman has entered into a
Institutes of Health (NIH): Based on • Figures 2 and 3 results for Z’-factor, Voluntary Settlement Agreement with
Respondent’s admission and analysis %CV, signal:background ratio, and a 10- ORI, in which she voluntarily agreed:
conducted by ORI, ORI found that Dr. point dose response titration experiment (1) To have her research supervised
Brandi M. Baughman, former Intramural for inhibitor UNC10225354 for a period of three (3) years beginning
Research Training Awardee, National • claims in the text of PLoS One 2016 on May 17, 2017; Respondent agreed to
Institute of Environmental and Health that eight molecules from the PKIS ensure that prior to the submission of an
Sciences (NIEHS), NIH, engaged in library and fifteen molecules from the application for U.S. Public Health
research misconduct in research 5K library inhibited PPIP5K activity by Service (PHS) support for a research
>50% project on which Respondent’s
sradovich on DSK3GMQ082PROD with NOTICES
supported by National Institute of
Diabetes and Digestive and Kidney • Figure 4D results for the inhibition participation is proposed and prior to
Diseases (NIDDK), NIH, grant R01 by UNC10112646, UNC10225354, and Respondent’s participation in any
DK101645 and the NIEHS, NIH, UNC10225498, in dose response assays capacity on PHS-supported research,
Postdoctoral Intramural Research against the kinase domain of PPIP5K Respondent shall ensure that a plan for
Training Award (IRTA). • Figures 5A and 5B results for supervision of Respondent’s duties is
ORI found that falsified and/or isothermal titration calorimetry (ITC) submitted to ORI for approval; the
fabricated data were included in eleven assays for quantifying intermolecular supervision plan must be designed to
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Document Created: 2017-06-20 02:20:45
Document Modified: 2017-06-20 02:20:45
| 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 | Submit either electronic or written comments on the collection of information by August 21, 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 28076 |
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