82 FR 37101 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 151 (August 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37101-37103 | |
| FR Document | 2017-16648 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37101-37103] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16648] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0588] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile 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 September 7, 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 0910-0614. 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. Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; OMB Control Number 0910-0614-- Extension Under the Public Health Service Act (PHS Act), the Department of Health and Human Services stockpiles medical products that are essential to the health security of the Nation (see the PHS Act, 42 U.S.C. 247d-6b). This collection of medical products for use during national health emergencies, known as the Strategic National Stockpile (SNS), is to ``provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.'' It may be appropriate for certain medical products that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling regulations given their anticipated circumstances of use in an emergency. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352). [[Page 37102]] Under 21 CFR 201.26, 610.68, 801.128, and 809.11 (Sec. Sec. 201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center Director may grant a request for an exception or alternative to certain regulatory provisions pertaining to the labeling of human drugs, biological products, medical devices, and in vitro diagnostics that currently are or will be included in the SNS if certain criteria are met. The appropriate FDA Center Director may grant an exception or alternative to certain FDA labeling requirements if compliance with these labeling requirements could adversely affect the safety, effectiveness, or availability of products that are or will be included in the SNS. An exception or alternative granted under the regulations may include conditions or safeguards so that the labeling for such products includes appropriate information necessary for the safe and effective use of the product given the product's anticipated circumstances of use. Any grant of an exception or alternative will only apply to the specified lots, batches, or other units of medical products in the request. The appropriate FDA Center Director may also grant an exception or alternative to the labeling provisions specified in the regulations on his or her own initiative. Under Sec. Sec. 201.26(b)(1)(i) (human drug products), 610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human use), an SNS official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores such products that are or will be included in the SNS may submit, with written concurrence from a SNS official, a written request for an exception or alternative to certain labeling requirements to the appropriate FDA Center Director. Except when initiated by an FDA Center Director, a request for an exception or alternative must be in writing and must:Identify the specified lots, batches, or other units of the affected product; Identify the specific labeling provisions under the regulations that are the subject of the request; Explain why compliance with the specified labeling provisions could adversely affect the safety, effectiveness, or availability of the product subject to the request; Describe any proposed safeguards or conditions that will be implemented so that the labeling of the product includes appropriate information necessary for the safe and effective use of the product given the anticipated circumstances of use of the product; Provide copies of the proposed labeling of the specified lots, batches, or other units of the affected product that will be subject to the exception or alternative; and Provide any other information requested by the FDA Center Director in support of the request. If the request is granted, the manufacturer may need to report to FDA any resulting changes to the new drug application, biologics license application, premarket approval application, or premarket notification (510(k)) in effect, if any. The submission and grant of an exception or an alternative to the labeling requirements specified in the regulations may be used to satisfy certain reporting obligations relating to changes to product applications under Sec. Sec. 314.70, 601.12, 814.39 and 807.81 (21 CFR 314.70 (human drugs), 21 CFR 601.12 (biological products), 21 CFR 814.39 (medical devices subject to premarket approval), or 21 CFR 807.81 (medical devices subject to 510(k) clearance requirements)). The information collection provisions in Sec. Sec. 314.70, 601.12, 807.81, and 814.39 have been approved under OMB control numbers 0910- 0001, 0910-0338, 0910-0120, and 0910-0231, respectively. On a case-by- case basis, the appropriate FDA Center Director may also determine when an exception or alternative is granted that certain safeguards and conditions are appropriate, such as additional labeling on the SNS products, so that the labeling of such products would include information needed for safe and effective use under the anticipated circumstances of use. Respondents to this collection of information are entities that manufacture (including labeling, packing, relabeling, or repackaging), distribute, or store affected SNS products. Based on data from fiscal years 2014 and 2015, FDA estimates an average of one request annually for an exception or alternative received by FDA. FDA estimates an average of 24 hours preparing each request. The average burden per response for each submission is based on the estimated time that it takes to prepare a supplement to an application, which may be considered similar to a request for an exception or alternative. To the extent that labeling changes not already required by FDA regulations are made in connection with an exception or alternative granted under the regulations, FDA is estimating one occurrence annually in the event FDA would require any additional labeling changes not already covered by FDA regulations. FDA estimates 8 hours to develop and revise the labeling to make such changes. The average burden per response for each submission is based on the estimated time to develop and revise the labeling to make such changes. In the Federal Register of May 23, 2017 (82 FR 23584), 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 of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR Section Number of responses per Total annual per response Total hours respondents respondent responses (in hours) ---------------------------------------------------------------------------------------------------------------- 201.26(b)(1)(i), 1 1 1 24 24 610.68(b)(1)(i), 801.128(b)(1)(i), and 809.11(b)(1)(i)................ 201.26(b)(1)(i), 1 1 1 8 8 610.68(b)(1)(i), 801.128(b)(1)(i), and 809.11(b)(1)(i)................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 32 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 37103]] Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16648 Filed 8-7-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37101
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of disclosures Total annual
21 CFR section/activity burden per Total hours
respondents per disclosures disclosure
respondent
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 per year. Therefore, we estimate that the OMB recommends that written
incremental time that establishments number of disclosures per respondent comments be faxed to the Office of
need to design and print labeling that will be 21 (31,878 SKUs) for § 701.3 and Information and Regulatory Affairs,
includes the following required 24 each (36,432 SKUs) for §§ 701.11, OMB, Attn: FDA Desk Officer, FAX:
elements: A declaration of ingredients 701.12, and 701.13. 202–395–7285, or emailed to oira_
in decreasing order of predominance, a We estimate that each of the required submission@omb.eop.gov. All
statement of the identity of the product, label elements may add approximately 1 comments should be identified with the
a specification of the name and place of hour to the label design process. We OMB control number 0910–0614. Also
business of the establishment, and a base this estimate on the hour burdens include the FDA docket number found
declaration of the net quantity of the Agency has previously estimated for in brackets in the heading of this
contents. These requirements increase food, drug, and medical device labeling document.
the time establishments need to design and on the Agency’s knowledge of
FOR FURTHER INFORMATION CONTACT:
labels because they increase the number cosmetic labeling. Therefore, we
of label elements that establishments estimate that the total hour burden on Domini Bean, Office of Operations,
must take into account when designing members of the public for this Food and Drug Administration, Three
labels. These requirements do not information collection is 141,174 hours White Flint North, 10A63, 11601
generate any recurring burden per label per year. Landsdown St., North Bethesda, MD
because establishments must already 20852, 301–796–5733, PRAStaff@
Dated: August 2, 2017. fda.hhs.gov.
print and affix labels to cosmetic Anna K. Abram,
products as part of normal business SUPPLEMENTARY INFORMATION: In
Deputy Commissioner for Policy, Planning,
practices. Legislation, and Analysis. compliance with 44 U.S.C. 3507, FDA
The estimated annual third-party [FR Doc. 2017–16649 Filed 8–7–17; 8:45 am] has submitted the following proposed
disclosure is based on data available to collection of information to OMB for
BILLING CODE 4164–01–P
the Agency, our knowledge of and review and clearance.
experience with cosmetic labeling, and
our communications with industry. We Exceptions or Alternatives to Labeling
DEPARTMENT OF HEALTH AND Requirements for Products Held by the
estimate there are 1,518 cosmetic HUMAN SERVICES
product establishments in the United Strategic National Stockpile; OMB
States. We calculate label design costs Control Number 0910–0614—Extension
Food and Drug Administration
based on stock keeping units (SKUs) Under the Public Health Service Act
[Docket No. FDA–2010–N–0588]
because each SKU has a unique product (PHS Act), the Department of Health
label. Based on data available to the Agency Information Collection and Human Services stockpiles medical
Agency and on communications with Activities; Submission for Office of products that are essential to the health
industry, we estimate that cosmetic Management and Budget Review; security of the Nation (see the PHS Act,
establishments will offer 94,800 SKUs Comment Request; Exceptions or 42 U.S.C. 247d–6b). This collection of
for retail sale in 2017. This corresponds Alternatives to Labeling Requirements medical products for use during
to an average of 62 SKUs per for Products Held by the Strategic national health emergencies, known as
establishment. National Stockpile the Strategic National Stockpile (SNS),
One of the four provisions that we is to ‘‘provide for the emergency health
discuss in this information collection, AGENCY: Food and Drug Administration, security of the United States, including
§ 701.3, applies only to cosmetic HHS. the emergency health security of
products offered for retail sale. ACTION: Notice. children and other vulnerable
However, the other three provisions, populations, in the event of a
§§ 701.11, 701.12, and 701.13, apply to SUMMARY: The Food and Drug bioterrorist attack or other public health
all cosmetic products, including non- Administration (FDA) is announcing emergency.’’ It may be appropriate for
retail professional-use-only products. that a proposed collection of certain medical products that are or will
We estimate that including professional- information has been submitted to the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
be held in the SNS to be labeled in a
use-only cosmetic products increases Office of Management and Budget manner that would not comply with
the total number of SKUs by 15 percent (OMB) for review and clearance under certain FDA labeling regulations given
to 109,020. This corresponds to an the Paperwork Reduction Act of 1995. their anticipated circumstances of use in
average of 72 SKUs per establishment. DATES: Fax written comments on the an emergency. However, noncompliance
Finally, based on the Agency’s collection of information by September with these labeling requirements could
experience with other products, we 7, 2017. render such products misbranded under
estimate that cosmetic establishments ADDRESSES: To ensure that comments on section 502 of the Federal Food, Drug,
may redesign up to one-third of SKUs the information collection are received, and Cosmetic Act (21 U.S.C. 352).
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![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37103
Dated: August 2, 2017. information, please include the discuss transplants with their care team,
Anna K. Abram, information request collection title for (4) increase in awareness of available
Deputy Commissioner for Policy, Planning, reference, in compliance with Section resources, (5) timeliness of response,
Legislation, and Analysis. 3506(c)(2)(A) of the Paperwork and (6) overall satisfaction.
[FR Doc. 2017–16648 Filed 8–7–17; 8:45 am] Reduction Act of 1995. The proposed changes to the survey
BILLING CODE 4164–01–P Information Collection Request Title: instrument include minor changes to
Office of Patient Advocacy/Be The both selected survey questions and the
Match® Patient Services Survey, OMB instructions. The updated survey
DEPARTMENT OF HEALTH AND No. 0906–0004—Revision. questions include simplified language
HUMAN SERVICES Abstract: The National Marrow Donor and the references to race and ethnicity
Program®/Be The Match® is a HRSA are updated to better match preliminary
Health Resources and Services contractor dedicated to helping patients
Administration U.S. Census Bureau question format and
and families get the support and statements from the U.S. Department of
information they need to learn about Education. The question format changes
Agency Information Collection
their disease and treatment options, will better allow individuals to self-
Activities: Proposed Collection: Public
prepare for a blood stem cell transplant, identify their ethnicity and race and
Comment Request Information
and thrive after a transplant procedure. permit individuals to select more than
Collection Request Title: Office of
The information and resources provided
Patient Advocacy/Be The Match® one race and/or ethnicity. These
help individuals navigate the bone changes will not increase respondent
Patient Services Survey, OMB No.
0906–0004, Revision marrow or cord blood transplant burden.
process. Participant feedback is
AGENCY: Health Resources and Services essential to understand the needs for Likely Respondents: Respondents will
Administration (HRSA), Department of transplant support services and include all patients, caregivers and
Health and Human Services. educational information across a diverse family members who have contact with
ACTION: Notice. population. This information is used to Be The Match Patient Services
determine helpfulness of existing Coordinators via phone or email for
SUMMARY: In compliance with the services and resources. Feedback is also transplant navigation services and
requirement for opportunity for public used to identify areas for improvement support. The decision to survey all
comment on proposed data collection and develop future programs. participants was made based on historic
projects of the Paperwork Reduction Act Need and Proposed Use of the evidence of patients’ unavailability due
of 1995, HRSA announces plans to Information: Barriers to access to bone to frequent transitions in health status
submit an Information Collection marrow or cord blood transplant related as well as between home and the
Request (ICR), described below, to the care and educational information are hospital for initial treatment and care
Office of Management and Budget multi-factorial. Feedback from for complications.
(OMB). Prior to submitting the ICR to participants is essential to better Burden Statement: Burden in this
OMB, HRSA seeks comments from the understand the changing needs for context means the time expended by
public regarding the burden estimate, services and information as well as to persons to generate, maintain, retain,
below, or any other aspect of the ICR. demonstrate the effectiveness of existing disclose or provide the information
DATES: Comments on this ICR must be services. The primary use for requested. This includes the time
received no later than October 10, 2017. information gathered through the survey needed to review instructions; to
ADDRESSES: Submit your comments to is to determine helpfulness of develop, acquire, install, and utilize
paperwork@hrsa.gov or mail the HRSA participants’ initial contact with Be The technology and systems for the purpose
Information Collection Clearance Match® Patient Services Coordinators of collecting, validating, and verifying
Officer, Room 14N39, 5600 Fishers (PSC) and to identify areas for information, processing and
Lane, Rockville, MD 20857. improvement in the delivery of services. maintaining information, and disclosing
FOR FURTHER INFORMATION CONTACT: To In addition, stakeholders use this and providing information; to train
request more information on the evaluation data to make program and personnel and to be able to respond to
proposed project or to obtain a copy of resource allocation decisions. a collection of information; to search
the data collection plans and draft The survey includes items to measure data sources; to complete and review
instruments, email paperwork@hrsa.gov the following: (1) Reason for contacting the collection of information; and to
or call the HRSA Information Collection Be The Match®, (2) if the PSC was able transmit or otherwise disclose the
Clearance Officer at (301) 443–1984. to answer questions and was easy to information. The total annual burden
SUPPLEMENTARY INFORMATION: When understand, (3) if the contact helped the hours estimated for this ICR are
submitting comments or requesting participant to feel better prepared to summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total
Form name responses per
respondents responses response burden hours
respondent (in hours)
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Be The Match Patient Services Survey ............................... 420 1 420 0.25 105
Total .............................................................................. 420 ........................ 420 ........................ 105
HRSA specifically requests comments proposed information collection for the functions; (2) the accuracy of the
on (1) the necessity and utility of the proper performance of the agency’s estimated burden; (3) ways to enhance
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Document Created: 2017-08-08 00:18:00
Document Modified: 2017-08-08 00:18:00
| 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 September 7, 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 37101 |
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