82 FR 23578 - Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 98 (May 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 98 (May 23, 2017)
| Page Range | 23578-23581 | |
| FR Document | 2017-10537 |
[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)] [Notices] [Pages 23578-23581] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10537] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0349] Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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 collection of information associated with the Guidance ``Providing Post-market Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' DATES: Submit either electronic or written comments on the collection of information by July 24, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 24, 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. ADDRESSES: You may submit comments as follows: 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 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 [[Page 23579]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-D-0349 for ``Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format.'' Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 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. Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report), OMB Control Number 0910-0771-- Extension The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use issued, on November 15, 2012, the ICH harmonized tripartite guideline entitled ``Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2)'' (the PBRER guideline) (available at http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html). The PBRER guideline is intended to promote a consistent approach to periodic post-marketing safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities. The PBRER is intended to provide a common standard for periodic reporting on approved drugs or biologics among the ICH regions. FDA currently has OMB approval for the required submission of periodic adverse drug experience reports (PADER) for drugs subject to a new drug application (NDA) or an abbreviated new drug application (ANDA) (Sec. [thinsp]314.80(c)(2) (21 CFR 314.80(c)(2)) (OMB control number 0910-0230), and for the required submission of periodic adverse experience reports (PAER) for drugs subject to a biologics license application (BLA) (Sec. [thinsp]600.80(c)(2) (21 CFR 600.80(c)(2)) (OMB control number 0910-0308). There is considerable overlap in the information required under Sec. Sec. [thinsp]314.80(c)(2) and 600.80(c)(2) and the information requested in a periodic safety report using the ICH E2C(R2) PBRER format. Applicants subject to periodic safety reporting requirements under FDA regulations could choose to continue to submit the reports as specified in those regulations, and would be permitted to submit reports in the PBRER format and submit reports as specified in FDA regulations with an approved waiver. Companies who submit periodic reports on the same drug to multiple regulators, including not only the United States, but, also the European Union, Japan, and regulators in other countries who have elected to adopt the ICH standards, may find it in their interest to prepare a single PBRER, [[Page 23580]] rather than preparing multiple types of reports for multiple regulators. As a result, FDA, in the Federal Register of November 29, 2016 (81 FR 85976), announced the availability of the guidance for industry entitled ``Providing Post-marketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)'' to indicate its willingness to accept post-market periodic safety reports using the ICH PBRER format in lieu of the specific reports described in FDA regulations. Because FDA regulations in Sec. Sec. [thinsp]314.80(c)(2) and 600.80(c)(2) include specific requirements for periodic safety reports, in order for an applicant to submit an alternative report, such as the PBRER, for a given product, FDA must grant a waiver. Existing regulations permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under existing control numbers. (See Sec. [thinsp]314.90(a), waivers for drugs subject to NDAs and ANDAs, approved under OMB control number 0910-0001, and Sec. [thinsp]600.90(a), waivers for products subject to BLAs, approved under OMB control number 0910-0308.) The November 29, 2016, guidance both explains conditions under which applicants that have previously received waivers to submit reporting information in the format of the previous ICH guidance would be permitted to apply those existing waivers to the submission of PBRERs, and also advises how applicants that have not previously obtained a waiver may submit waiver requests to submit the PBRER. There are information collections proposed in the November 29, 2016, guidance that are related to waivers specifically to enable the submission of PBRERs, and these information collections are not already addressed under the approved control numbers covering waiver submissions and periodic safety reports generally. FDA has previously granted waiver requests, submitted under Sec. Sec. [thinsp]314.90(a) and 600.90(a), that allow applicants to prepare and submit reports using the periodic safety update report (PSUR) format described in FDA's 1996 and 2004 ICH E2C guidance. In accordance with the recommendations of the November 29, 2016, guidance, if an applicant already has a PSUR waiver in place for a given approved application, FDA will consider the existing PSUR waiver to allow the applicant to submit a PBRER instead of a PSUR because the PBRER replaces the PSUR for post-marketing periodic safety reporting for that application. The applicant would not need to submit a new waiver request unless the applicant wishes to change the frequency of reporting. FDA will consider requests to be waived of the quarterly reporting requirement but will not waive applicants of the annual reporting requirement. If an applicant submits a PBRER in place of the PSUR and uses a different data lock point, the applicant should submit overlapping reports or submit a one-time PADER/PAER in order to cover the gap in reporting intervals. The applicant should submit notification to the application(s), indicating the change in data lock point and should include a description of the measures taken to ensure that there are no resulting gaps in reporting. If an applicant submits a PBRER in place of the PSUR and uses a different reporting frequency for the PBRER than was used for the PSUR, the continued validity of the waiver will be conditioned on the submission of a PADER/PAER as needed to fulfill the reporting frequency requirement under FDA regulations. The applicant should submit a notification to the application(s), describing this change and the measures taken to ensure that the periodicity requirements are being met. FDA expects approximately 187 waiver requests and notifications to include the additional information described previously in this document for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 55 applicants to make these submissions, and we estimate that the time for submitting the additional information described previously would be on average approximately 1 hour for each waiver request or notification. If an applicant does not have a PSUR waiver in place for an approved application, the applicant may submit a waiver request under Sec. [thinsp]314.90(a) or Sec. [thinsp]600.90(a) to submit a PBRER instead of the PADER/PAER. The applicant should submit a request to FDA for each approved application for which a waiver is requested, and a single waiver request letter can include multiple applications. Waiver requests should be submitted to each of the application(s) in the request, and may be submitted electronically or by mail as described in the November 29, 2016, guidance. Each PBRER waiver request should include the following information: The product name(s) and application number(s); a brief description of the justification for the request; the U.S. approval date for the product(s) and current reporting interval used; the reporting interval of the last PADER/PAER submitted for the product(s); and the data lock point that will be used for each PBRER. If a data lock point other than one aligned to the U.S. approval date is proposed, the applicant should describe how he/she will ensure that there are no gaps in reporting intervals (e.g., by submitting overlapping reports; submitting a one-time PADER/PAER to cover the gap period; or, if the gap is less than 2 months, extending the reporting interval of the final PADER/PAER to close the gap). The frequency for submitting the PBRER, as described in section IV.C of the April 8, 2013, draft guidance. The email address and telephone number for the individual who can provide additional information regarding the waiver request. As explained earlier, existing regulations at Sec. 314.90(a) or 600.90(a) permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under OMB control numbers 0910-0001 and 0910-0308. FDA believes that the information submitted under numbers 1-4 and number 7 in the list in the previous paragraph is information that is typical of any waiver request regarding post-marketing safety reporting and is accounted for in the existing approved collections of information for waiver requests and reports. Concerning numbers 5 and 6, FDA expects approximately 67 waiver requests to include the additional information for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 29 applicants to make these submissions, and we estimate that the time for submitting the additional information described in the previous paragraph would be on average approximately 2 hours for each waiver request. FDA estimates the additional burden of this collection of information as follows: [[Page 23581]] Table 1--Estimated Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Additional information and/or notifications for using a Number of Number of Total annual Average different data lock point and/or respondents responses per responses burden per Total hours a different reporting frequency respondent response ---------------------------------------------------------------------------------------------------------------- Applicants that have a PSUR 55 3.4 187 1 187 waiver for an approved application.................... Applicants that do not have a 29 2.3 67 2 134 PSUR waiver for an approved application.................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 321 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital or operating and maintenance costs associated with the information collection. Dated: May 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-10537 Filed 5-22-17; 8:45 am] BILLING CODE 4164-01-P
![23578 Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
21 CFR section/activity disclosures burden per Total hours
respondents disclosures
per respondent disclosure
701.3—Ingredients in order of predominance ................... 1,518 21 31,878 1 31,878
701.11—Statement of identity ........................................... 1,518 24 36,432 1 36,432
701.12—Name and place of business .............................. 1,518 24 36,432 1 36,432
701.13—Net quantity of contents ...................................... 1,518 24 36,432 1 36,432
Total ............................................................................ ........................ .......................... ........................ ........................ 141,174
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The hour burden is the additional or may redesign up to one-third of SKUs extension of an existing collection of
incremental time that establishments per year. Therefore, we estimate that the information, and to allow 60 days for
need to design and print labeling that number of disclosures per respondent public comment in response to the
includes the following required will be 21 (31,878 SKUs) for § 701.3 and notice. This notice solicits comments on
elements: A declaration of ingredients 24 each (36,432 SKUs) for §§ 701.11, the collection of information associated
in decreasing order of predominance, a 701.12, and 701.13. with the Guidance ‘‘Providing Post-
statement of the identity of the product, We estimate that each of the required market Periodic Safety Reports in the
a specification of the name and place of label elements may add approximately 1 ICH E2C(R2) Format (Periodic Benefit-
business of the establishment, and a hour to the label design process. We Risk Evaluation Report).’’
declaration of the net quantity of base this estimate on the hour burdens DATES: Submit either electronic or
contents. These requirements increase the Agency has previously estimated for written comments on the collection of
the time establishments need to design food, drug, and medical device labeling information by July 24, 2017. Late,
labels because they increase the number and on the Agency’s knowledge of untimely filed comments will not be
of label elements that establishments cosmetic labeling. Therefore, we considered. Electronic comments must
must take into account when designing estimate that the total hour burden on be submitted on or before July 24, 2017.
labels. These requirements do not members of the public for this The https://www.regulations.gov
generate any recurring burden per label information collection is 141,174 hours electronic filing system will accept
because establishments must already per year. comments until midnight Eastern Time
print and affix labels to cosmetic Dated: May 18, 2017. at the end of July 24, 2017. Comments
products as part of normal business Anna K. Abram, received by mail/hand delivery/courier
practices. Deputy Commissioner for Policy, Planning, (for written/paper submissions) will be
The estimated annual third party Legislation, and Analysis. considered timely if they are
disclosure is based on data available to [FR Doc. 2017–10532 Filed 5–22–17; 8:45 am] postmarked or the delivery service
the Agency, our knowledge of and BILLING CODE 4164–01–P acceptance receipt is on or before that
experience with cosmetic labeling, and date.
our communications with industry. We ADDRESSES: You may submit comments
estimate there are 1,518 cosmetic DEPARTMENT OF HEALTH AND as follows:
product establishments in the United HUMAN SERVICES
States. We calculate label design costs Electronic Submissions
based on stock keeping units (SKUs) Food and Drug Administration Submit electronic comments in the
because each SKU has a unique product [Docket No. FDA–2013–D–0349] following way:
label. Based on data available to the • Federal eRulemaking Portal:
Agency and on communications with Agency Information Collection https://www.regulations.gov. Follow the
industry, we estimate that cosmetic Activities; Proposed Collection; instructions for submitting comments.
establishments will offer 94,800 SKUs Comment Request; Providing Waiver- Comments submitted electronically,
for retail sale in 2017. This corresponds Related Materials in Accordance With including attachments, to https://
to an average of 62 SKUs per the Guidance for Industry on Providing www.regulations.gov will be posted to
establishment. Post-Market Periodic Safety Reports in the docket unchanged. Because your
One of the four provisions that we the International Conference on comment will be made public, you are
discuss in this information collection, Harmonisation E2C(R2) Format solely responsible for ensuring that your
§ 701.3, applies only to cosmetic AGENCY: Food and Drug Administration, comment does not include any
products offered for retail sale. HHS. confidential information that you or a
However, the other three provisions, third party may not wish to be posted,
ACTION: Notice.
§§ 701.11, 701.12, and 701.13, apply to such as medical information, your or
all cosmetic products, including non- SUMMARY: The Food and Drug anyone else’s Social Security number, or
retail professional-use-only products. Administration (FDA) is announcing an confidential business information, such
We estimate that including professional- opportunity for public comment on the as a manufacturing process. Please note
sradovich on DSK3GMQ082PROD with NOTICES
use-only cosmetic products increases proposed collection of certain that if you include your name, contact
the total number of SKUs by 15 percent information by the Agency. Under the information, or other information that
to 109,020. This corresponds to an Paperwork Reduction Act of 1995 identifies you in the body of your
average of 72 SKUs per establishment. (PRA), Federal Agencies are required to comments, that information will be
Finally, based on the Agency’s publish notice in the Federal Register posted on https://www.regulations.gov.
experience with other products, we concerning each proposed collection of • If you want to submit a comment
estimate that cosmetic establishments information, including each proposed with confidential information that you
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![Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices 23581
TABLE 1—ESTIMATED REPORTING BURDEN 1
Additional information and/or notifications for using a Number of Average
Number of Total annual
different data lock point and/or a different reporting responses per burden per Total hours
respondents responses
frequency respondent response
Applicants that have a PSUR waiver for an approved ap-
plication ............................................................................ 55 3.4 187 1 187
Applicants that do not have a PSUR waiver for an ap-
proved application ............................................................ 29 2.3 67 2 134
Total .............................................................................. ........................ ........................ ........................ ........................ 321
1 There are no capital or operating and maintenance costs associated with the information collection.
Dated: May 18, 2017. the instructions for submitting of Dockets Management between 9 a.m.
Anna K. Abram, comments. Comments submitted and 4 p.m., Monday through Friday.
Deputy Commissioner for Policy, Planning, electronically, including attachments, to • Confidential Submissions—To
Legislation, and Analysis. https://www.regulations.gov/ will be submit a comment with confidential
[FR Doc. 2017–10537 Filed 5–22–17; 8:45 am] posted to the docket unchanged. information that you do not wish to be
BILLING CODE 4164–01–P Because your comment will be made made publicly available, submit your
public, you are solely responsible for comments only as a written/paper
ensuring that your comment does not submission. You should submit two
DEPARTMENT OF HEALTH AND include any confidential information copies total. One copy will include the
HUMAN SERVICES that you or a third party may not wish information you claim to be confidential
to be posted, such as medical with a heading or cover note that states
Food and Drug Administration information, your or anyone else’s ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2014–N–0222] Social Security number, or confidential CONFIDENTIAL INFORMATION.’’ The
business information, such as a Agency will review this copy, including
Agency Information Collection manufacturing process. Please note that the claimed confidential information, in
Activities; Proposed Collection; if you include your name, contact its consideration of comments. The
Comment Request; Guidance for information, or other information that second copy, which will have the
Industry—User Fee Waivers, identifies you in the body of your claimed confidential information
Reductions, and Refunds for Drug and comments, that information will be redacted/blacked out, will be available
Biological Products posted on https://www.regulations.gov/. for public viewing and posted on
If you want to submit a comment with https://www.regulations.gov/. Submit
AGENCY: Food and Drug Administration, confidential information that you do not both copies to the Division of Dockets
HHS. wish to be made available to the public, Management. If you do not wish your
ACTION: Notice. submit the comment as a written/paper name and contact information to be
submission and in the manner detailed made publicly available, you can
SUMMARY: The Food and Drug (see ‘‘Written/Paper Submissions’’ and provide this information on the cover
Administration (FDA or Agency) is ‘‘Instructions’’). sheet and not in the body of your
announcing an opportunity for public comments and you must identify this
comment on the proposed collection of Written/Paper Submissions
information as ‘‘confidential.’’ Any
certain information by the Agency. Submit written/paper submissions as information marked as ‘‘confidential’’
Under the Paperwork Reduction Act of follows: will not be disclosed except in
1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for accordance with 21 CFR 10.20 and other
required to publish notice in the written/paper submissions): Division of applicable disclosure law. For more
Federal Register concerning each Dockets Management (HFA–305), Food information about FDA’s posting of
proposed collection of information, and Drug Administration, 5630 Fishers comments to public dockets, see 80 FR
including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852. 56469, September 18, 2015, or access
existing collection of information, and • For written/paper comments the information at: https://www.gpo.gov/
to allow 60 days for public comment in submitted to the Division of Dockets fdsys/pkg/FR-2015-09-18/pdf/2015-
response to the notice. This notice Management, FDA will post your 23389.pdf.
solicits comments on recommendations comment, as well as any attachments, Docket: For access to the docket to
to applicants considering whether to except for information submitted, read background documents or the
request a waiver or reduction in user marked and identified, as confidential, electronic and written/paper comments
fees. if submitted as detailed in received, go to https://
DATES: Submit either electronic or ‘‘Instructions.’’ www.regulations.gov/ and insert the
written comments on the collection of Instructions: All submissions received docket number, found in brackets in the
information by July 24, 2017. must include the Docket No. FDA– heading of this document, into the
2014–N–0222 for ‘‘User Fee Waivers, ‘‘Search’’ box and follow the prompts
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES: You may submit comments
as follows: Reductions, and Refunds for Drug and and/or go to the Division of Dockets
Biological Products.’’ Received Management, 5630 Fishers Lane, Rm.
Electronic Submissions comments will be placed in the docket 1061, Rockville, MD 20852.
Submit electronic comments in the and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
following way: ‘‘Confidential Submissions,’’ publicly JonnaLynn Capezzuto, Office of
• Federal eRulemaking Portal: viewable at https:// Operations, Food and Drug
https://www.regulations.gov/. Follow www.regulations.gov/ or at the Division Administration, Three White Flint
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Document Created: 2017-05-23 02:14:49
Document Modified: 2017-05-23 02:14:49
| 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 | Submit either electronic or written comments on the collection of information by July 24, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 24, 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. | |
| 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 23578 |
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